Letters for Issue on 06.06.2014
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LETTERS FOR ISSUE ON 06.06.2014 GLOBAL CLINICAL TRIAL
Sr. No. Name of Firm Reference No. Type of Letter 1. M/s. J&J 54739/59052 Clarification letter 2. M/s. Parexel 2671 Clarification Letter 3. M/s. PPD - Clarification Letter
BE NOC FOR EXPORT
S. NO. NAME OF THE COMPANY REF. NO. Type of letter
1. M/s. APL Research Centre, Hyderabad- 56941 Approval Letter 500 090
2. M/s. Azidus Laboratories Ltd., Chennai- 17446 Clarification 600 048 Letter
3. M/s. Cipla Ltd., Mumbai-400 008 14565 Rejection Letter
4. M/s. Cliantha Research Limited, 22053 Approval Letter Ahmedabad-380 054
5. M/s. Clinigene International Ltd., 17431 Approval Letter Bangalore-560 100
6. M/s. Lambda Therapeutic Research Ltd., 18199 Approval Letter Ahmedabad-380 061
7. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 16547 Approval Letter 052
8. M/s. Lupin Bioresearch Center, Pune-411 17212 Clarification 021 Letter
9. M/s. Lupin Bioresearch Center, Pune-411 18240 Approval Letter 021 10. M/s. Manipal AcuNova KMC Clinical 15303 Approval Letter Pharmacology Unit, Mangalore-575 001
11. M/s. Micro Therapeutic Research Labs 7785 Approval Letter Pvt. Ltd., Chennai-600059
12. M/s. Micro Therapeutic Research Labs 18168 Approval Letter Pvt. Ltd., Coimbatore-641029 Tamil Nadu
13. M/s. Psychotropics India Ltd., Haridwar- 15120 Clarification 249 403 Letter
ONLY TEST LICENCE FOR BE
S. NO. NAME OF THE COMPANY REF. NO. Type of letter
1. M/s. Accutest Research Laboratories (I) Pvt. 17994 Test Licence Ltd., Navi Mumbai-400 709
2. M/s. Apotex Research Pvt. Ltd., Bangalore-560 18177 Test Licence 099
3. M/s. Lambda Therapeutic Research Ltd., 18198 Test Licence Ahmedabad-380 061
4. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 18057 Test Licence
5. M/s. Lupin Bioresearch Center, Pune-411 021 18149 Test Licence
6. M/s. Lupin Bioresearch Center, Pune-411 021 18148 Test Licence
7. M/s. Semler Research Center Pvt. Ltd., 18207 Test Licence Bangalore-560078
8. M/s. Strides Arcolab Ltd., Bangalore -560076 16669 Test Licence
9. M/s. Watson Pharma Pvt. Ltd., Navi Mumbai- 17434 Test Licence 400 614
MEDICAL DEVICE
S.NO. COMPANY NAME DIARY NO STATUS 1. M/s. Biotech Vision Care Pvt. Ltd. 17192 Query Letter
2. M/s. Baxter (India) Pvt. Ltd. 14298 Query Letter
3. M/s. B. L. Life Sciences Pvt. Ltd. 15108 Query Letter
4. M/s. Covidien Healthcare India Pvt. Ltd. 19625 Query Letter
5. M/s. Depuy Medical Pvt. Ltd. 16590 Query Letter
6. M/s. Johnson & Johnson Ltd. 1650 Query Letter
7. M/s. Manju Enterprise Pvt. Ltd. 16403 Query Letter
8. M/s. St. Jude Medical Pvt. Ltd. 11825 Query Letter
9. M/s. Biorad Medisys Pvt. Ltd. (CLAA) 8060 Query Letter
DIAGNOSTIC DIVISION
S.NO. COMPANY NAME DIARY NO STATUS
1. M/s. ADI Diagnostics Pvt. Ltd. 17425 Query Letter
2. M/s. Biogenix Inc. 17146 Query Letter
3. M/s. Biosystem Diagnostics Pvt. Ltd. 16469 Query Letter
4. M/s. Piramal Enterprise Ltd. 16908 Query Letter
5. M/s. Innobreeze Technologies. FTS-20625 Query Letter
6. Dr. Neeru Singh, Jabalpur FTS-27336 Query Letter
SUBSEQUENT NEW DRUG
S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO.
1. M/s Intas 32617 45722 Deficiency Letter Pharmaceuticals Ltd.
TEST LICENCES S. No. Name of the Company Diary No. Type of Letter
1. Alkem Laboratories Ltd 19613,294 Approval Letter 28
2. Alkem Laboratories Ltd 19614,294 Approval Letter 59
3. Alkem Laboratories Ltd 19615,294 Approval Letter 60
4. Alkem Laboratories Ltd 19616,294 Approval Letter 61
5. Alkem Laboratories Ltd 19617,294 Approval Letter 62
6. Alphamed Formulations Pvt. 19394, Approval Letter Ltd 29305
7. Biocon Limited 19747, Approval Letter 29714
8. Biocon Limited 19748, Approval Letter 29711
9. Biocon Limited 19749, Approval Letter 29718
10. Biocon Limited 19750, Approval Letter 29842
11. Biocon Limited 19751, Approval Letter 29844
12. Biocon Limited 19752, Approval Letter 29847
13. Biocon Limited 19753, Approval Letter 29848
14. Biocon Limited 19754, Approval Letter 29850
15. Biocon Limited 19755, Approval Letter 29838 16. Biocon Limited 19756, Approval Letter 29834
17. Biocon Limited 19757, Approval Letter 29830
18. Biocon Limited 19758, Approval Letter 29829
19. Biocon Limited 19759, Approval Letter 29828
20. Biocon Limited 19763, Approval Letter 29825
21. Biocon Limited 19764. Approval Letter 29822
22. Cadila Pharmaceutical Limited 19537, Approval Letter 29244
23. Cadila Pharmaceutical Limited 19538, Approval Letter 29242
24. Cipla Ltd 19631,293 Approval Letter 21
25. Cipla Ltd 19632,293 Approval Letter 17
26. Cipla Ltd 19633,293 Approval Letter 12
27. Cipla Ltd 19634,293 Approval Letter 08
28. Cipla Ltd 19635,293 Approval Letter 04
29. Claris Lifesciences Ltd 19389, Approval Letter 29316
30. Claris Lifesciences Ltd 19390, Approval Letter 29311
31. Emcure Pharmaceuticals Ltd 19548, Approval Letter 29391
32. Evonik India Pvt Ltd 18225, Approval Letter 27726
33. Getz Pharma Research Pvt. Ltd 19773, Approval Letter 29816
34. Glenmark Generics Ltd 19514, Approval Letter 29036
35. Glenmark Generics Ltd 19685, Approval Letter 29267
36. Glenmark Generics Ltd 19686, Approval Letter 29252
37. Glenmark Generics Ltd 19687, Approval Letter 29250
38. Glenmark Generics Ltd 19688, Approval Letter 29249
39. Hospira Healthcare India Pvt. 19624,294 Approval Letter Ltd 69
40. Indeus Life Sciences Pvt. Ltd 19524, Approval Letter 29034
41. Indeus Life Sciences Pvt. Ltd 19525, Approval Letter 29033
42. Indoco Remedies Ltd 19401, Approval Letter 29287
43. Indoco Remedies Ltd 19406, Approval Letter 29282
44. Indoco Remedies Ltd 19407, Approval Letter 29280
45. Indoco Remedies Ltd 19408, Approval Letter 29336
46. Inventia Healthcare Pvt. Ltd 19539, Approval Letter 29394 47. Jagsonpal Pharmaceuticals Ltd 19411, Approval Letter 29348
48. Johnson and Johnson Ltd 19449, Approval Letter 29246
49. Johnson and Johnson Ltd 19555, Approval Letter 29387
50. Johnson and Johnson Ltd 17989, Approval Letter 27013
51. Johnson and Johnson Ltd 17990, Approval Letter 27012
52. Jubilant Life Sciences Ltd 18507, Approval Letter 27613
53. Jubilant Life Sciences Ltd 17154, Approval Letter 25562
54. Lupin Ltd 19429, Approval Letter 29291
55. Lupin Ltd 19430, Approval Letter 29322
56. Lupin Ltd 19431, Approval Letter 29274
57. Lupin Ltd 19432, Approval Letter 29297
58. Lupin Ltd 19433, Approval Letter 29295
59. Perrigo Laboratories India Pvt 19630,293 Approval Letter Ltd 47
60. Piramal Enterprises Ltd 18485, Approval Letter 27612
61. Ranbaxy Laboratories Ltd 19402, Approval Letter 29330
62. Ranbaxy Laboratories Ltd 19562, Approval Letter 29346
63. Ranbaxy Laboratories Ltd 17181, Approval Letter 25499
64. Ranbaxy Laboratories Ltd 19563, Approval Letter 29343
65. Ranbaxy Laboratories Ltd 19564,293 Approval Letter 40
66. Ranbaxy Laboratories Ltd 19565,293 Approval Letter 35
67. Rubicon Research Pvt. Ltd 19566,294 Approval Letter 00
68. Rusan Pharma Ltd 18598, Approval Letter 27863
69. Rusan Pharma Ltd 18597, Approval Letter 27860
70. Strides Arcolab Ltd 19623,294 Approval Letter 67
71. Tevapharm India Private 19767, Approval Letter limited 29742
72. Tevapharm India Private 19768, Approval Letter limited 29750
73. Torrent Pharmaceuticals Ltd 19601,294 Approval Letter 20
74. Torrent Pharmaceuticals Ltd 19602,294 Approval Letter 22
75. Torrent Pharmaceuticals Ltd 19603,294 Approval Letter 25
76. Unichem Laboratories Ltd 19652, Approval Letter 29328
77. Unichem Laboratories Ltd. 19649,293 Approval Letter 42 78. Unichem Laboratories Ltd. 19650,293 Approval Letter S. No. COMPANY NAME Dy.No. STATUS 34 1 M/s79. Biovet UnichemPvt, Ltd Laboratories14407, Ltd. 13529 19651,293Approval &Approval Clarification Letter 31 Letter 2 M/s80. AbbottUSV India Limited Ltd 12577 19586,294Approval LetterApproval Letter 13 3 M/s81. Roche USVProduct(india) Limited 13817 19587,294ClarificationApproval Letter Letter Pvt, Ltd 16
4 M/s82. IntervetVerGo India Pharma Pvt, Ltd Research 7916 19523,Approval LetterApproval Letter Laboratories Pvt Ltd 29035
VACCINE DIVISION