LETTERS FOR ISSUE ON
20/01/2014
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Vascular Concepts Ltd. / 46961 / Approval (R-RC)
2. / M/s. Progen SAS Technologies India (P) Ltd. / 54724 / Clarification Letter
3. / The Deputy Drugs Controller (I), Gujarat (CLAA)
The Commissioner, Gujarat (CLAA)
M/s. Envision Scientific Pvt. Ltd., Gujarat (CLAA) / 60192 / Clarification Letter
4. / M/s. Advance Bionics India Pvt. Ltd. / 47504 / Clarification Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Abbott Healthcare Pvt. Ltd. / 62190 / Approval (IL)
2. / M/s. Wheecon Instruments Pvt. Ltd. / 62728 / Approval (IL)
3. / M/s. Rapid Diagnostic Pvt. Ltd. / 62328 / Approval (E-IL)
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Cipla Ltd. / 64251 / Approval Letter
2. / Cipla Ltd. / 64252 / Approval Letter
3. / Cipla Ltd. / 64250 / Approval Letter
4. / Cipla Ltd. / 64249 / Approval Letter
5. / Mehta Pharmaceutical Industries, / 64108 / Approval Letter
6. / Mehta Antibiotics Pvt. Ltd. / 64110 / Approval Letter
7. / Mehta Pharmaceutical Industries, / 64109 / Approval Letter
8. / Lalchand Bhimraj, / 64177 / Approval Letter
9. / General Import Company (India) Pvt. Ltd. / 64173 / Approval Letter
10. / General Import Company (India) Pvt. Ltd. / 64172 / Approval Letter
11. / General Import Company (India) Pvt. Ltd. / 64176 / Approval Letter
12. / General Import Company (India) Pvt. Ltd. / 64174 / Approval Letter
13. / General Import Company (India) Pvt. Ltd. / 64171 / Approval Letter
14. / General Import Company (India) Pvt. Ltd. / 64175 / Approval Letter
15. / FDC Limited / 64105 / Approval Letter
16. / FDC Limited / 64106 / Approval Letter
17. / FDC Limited / 64107 / Approval Letter
18. / Pragati Raw Pharma Pvt. Ltd. / 64111 / Approval Letter
19. / Shell-Life Sciences Pvt. Ltd. / 64118 / Approval Letter
20. / Shell-Life Sciences Pvt. Ltd. / 64117 / Approval Letter
21. / Shell-Life Sciences Pvt. Ltd. / 64116 / Approval Letter
22. / Shell-Life Sciences Pvt. Ltd. / 64119 / Approval Letter
23. / B.M. Chemie / 64140 / Approval Letter
24. / Unimex Pvt. Ltd. / 64139 / Approval Letter
25. / Pratistha Pharma, / 64121 / Approval Letter
26. / Pratistha Pharma, / 64120 / Approval Letter
27. / Global Exim / 64257 / Approval Letter
28. / Gorang International / 64141 / Approval Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / MSD PHARAMCEUTICALS PVT. LTD. / 63991 / Approval Letter
2. / UNI CHEMIE INTERNATIONAL / 28549,57930 / 2 Approval Letter
3. / ARCHERCHEM / 64576 / Approval Letter
4. / RUMIT INTERNATIONAL / 62764 / AMENDED LETTER
5. / A.MENARINI INDIA LTD. / 43089 / CLARIFICATION LETTER
6. / NOVARTIS HEALTHCARE LTD. / 43062 / CLARIFICATION LETTER
7. / ETHACHEM / 54473 / CLARIFICATION LETTER
8. / FLAVINE PHARMA PVT. LTD. / 61830 / CLARIFICATION LETTER
9. / DR. REDDY’S LABORATORIES LTD. / 63267 / CLARIFICATION LETTER
10. / UNI CHEMIC INTERNATIONAL / 47821 / CLARIFICATION LETTER
11. / WINDLAS HEALTHCARE PVT. LTD. / CLARIFICATION LETTER
12. / SANOFI-SYNTHELABO (I) LTD. / 59943 / CLARIFICATION LETTER
SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / TUTON PHARMACEUTICAL / 64472,64500 / 2 Approval Letter
2. / MEDOPHARM PVT. LTD. / 59538 / CLARIFICATION LETTER
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Bajaj Pharmaceuticals / 33171 / Letter
2. / M/s. Intas Pharmaceuticals Ltd., / 47483 / Approval Letter
3. / M/s. GlaxoSmithKline Pharmaceuticals Ltd., / 31344 / Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Baxter India Pvt. Ltd., Maharashtra / 1044 / Query
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / AET Laboratories Pvt. Ltd / 63758, 87595 / Approval Letter
2. / AET Laboratories Pvt. Ltd / 63759, 87597 / Approval Letter
3. / Aizant Drug Research Solutions Pvt. Ltd / 63826, 87491 / Approval Letter
4. / Aizant Drug Research Solutions Pvt. Ltd. / 63825, 87494 / Approval Letter
5. / Alpa Laboratories Ltd / 64075, 87539 / Approval Letter
6. / APL Research Centre / 63975, 87518 / Approval Letter
7. / APL Research Centre / 63981, 87432 / Approval Letter
8. / Apotex Research Pvt. Ltd / 63845, 87608 / Approval Letter
9. / Apothecon Pharmaceutical Pvt Ltd / 60331, 83410, 64269, 88055 / Approval Letter
10. / Cadila Healthcare Limited / 64076, 87544 / Approval Letter
11. / Cadila Healthcare Limited / 64077, 87555 / Approval Letter
12. / Cipla Ltd / 64029, 87514 / Approval Letter
13. / Cipla Ltd / 64031, 87434 / Approval Letter
14. / Cipla Ltd / 64037, 87436 / Approval Letter
15. / Cipla Ltd / 64035, 87438 / Approval Letter
16. / Cipla Ltd / 64032, 87440 / Approval Letter
17. / Cipla Ltd / 64031, 87441 / Approval Letter
18. / Cipla Ltd / 64036, 87445 / Approval Letter
19. / Cipla Ltd / 64030, 87442 / Approval Letter
20. / Cipla Ltd / 64038, 87599 / Approval Letter
21. / Cipla Ltd / 63870, 87602 / Approval Letter
22. / Cipla Ltd / 63869, 87605 / Approval Letter
23. / Cipla Ltd / 63868, 87607 / Approval Letter
24. / Cipla Ltd / 64053, 87548 / Approval Letter
25. / Cipla Ltd / 64026, 87552 / Approval Letter
26. / Cipla Ltd / 64048, 87527 / Approval Letter
27. / Cipla Ltd / 64050, 87532 / Approval Letter
28. / Cipla Ltd / 64047, 87533 / Approval Letter
29. / Cipla Ltd / 64052, 87536 / Approval Letter
30. / Cipla Ltd / 64049, 87526 / Approval Letter
31. / Cipla Ltd / 64051, 87483 / Approval Letter
32. / Cipla Ltd / 64040, 87495 / Approval Letter
33. / Cipla Ltd / 64033, 87497 / Approval Letter
34. / Cipla Ltd / 64027, 87504 / Approval Letter
35. / Cipla Ltd / 64025, 87507 / Approval Letter
36. / Cipla Ltd / 64039, 87510 / Approval Letter
37. / Cipla Ltd / 64028, 87512 / Approval Letter
38. / Emcure Pharmaceuticals Ltd / 63800, 87447 / Approval Letter
39. / Indoco Remedies Ltd / 64064, 87567 / Approval Letter
40. / Indoco Remedies Ltd / 64058, 87570 / Approval Letter
41. / Indoco Remedies Ltd / 64080, 87581 / Approval Letter
42. / Indoco Remedies Ltd / 64079, 87564 / Approval Letter
43. / Indoco Remedies Ltd. / 64082, 87573 / Approval Letter
44. / Indoco Remedies Ltd. / 64059, 87575 / Approval Letter
45. / Indoco Remedies Ltd. / 64081, 87577 / Approval Letter
46. / Indoco Remedies Ltd. / 64057, 87579 / Approval Letter
47. / Lupin Ltd / 59228, 81805, 64781, 88714 / Approval Letter
48. / Mylan Laboratories Ltd. / 63812, 87449 / Approval Letter
49. / Mylan Laboratories Ltd. / 63813, 87451 / Approval Letter
50. / Mylan Laboratories Ltd. / 63810, 87454 / Approval Letter
51. / Mylan Laboratories Ltd. / 63808, 87460 / Approval Letter
52. / Mylan Laboratories Ltd. / 63809, 87456 / Approval Letter
53. / Mylan Laboratories Ltd. / 63807, 87462 / Approval Letter
54. / Mylan Laboratories Ltd. / 63806, 87464 / Approval Letter
55. / Mylan Laboratories Ltd. / 63805, 87466 / Approval Letter
56. / Mylan Laboratories Ltd. / 63804, 87469 / Approval Letter
57. / Mylan Laboratories Ltd. / 63803, 87470 / Approval Letter
58. / Mylan Laboratories Ltd. / 63802, 87472 / Approval Letter
59. / Mylan Laboratories Ltd. / 63801, 87475 / Approval Letter
60. / Novartis Healthcare Pvt Ltd / 64041, 87500 / Approval Letter
61. / Ranbaxy Laboratories Ltd / 63843, 87486 / Approval Letter
62. / Ranbaxy Laboratories Ltd / 63824, 87493 / Approval Letter
63. / Rubicon Research Pvt. Ltd / 63865, 87612 / Approval Letter
64. / Rubicon Research Pvt. Ltd / 63866, 87613 / Approval Letter
65. / S. Zhaveri Pharmakem Pvt. Ltd / 64043, 87481 / Approval Letter
66. / Sun Pharma Advanced Research Company Ltd / 64046, 87520 / Approval Letter
67. / Sun Pharmaceutical Industries Ltd / 64056, 87583 / Approval Letter
68. / Sun Pharmaceutical Industries Ltd / 64054, 87562 / Approval Letter
69. / Sun Pharmaceutical Industries Ltd / 64045, 87522 / Approval Letter
70. / Sun Pharmaceutical Industries Ltd / 64044, 87479 / Approval Letter
71. / Suven Life Sciences Ltd / 63742, 87589 / Approval Letter
72. / Suven Life Sciences Ltd / 63743, 87590 / Approval Letter
73. / Suven Life Sciences Ltd / 63744, 87591 / Approval Letter
74. / Unimed Technologies Ltd / 64055, 87565 / Approval Letter
75. / Unimed Technologies Ltd / 64078, 87506 / Approval Letter
76. / Wintac Ltd / 63760, 87585 / Approval Letter
77. / Agila Specialties Pvt Ltd / 63463, 87206 / Deficiency Letter
78. / Agila Specialties Pvt Ltd / 64208, 87985 / Deficiency Letter
79. / Aizant Drug Research Solutions Pvt Ltd / 64685, 88794 / Deficiency Letter
80. / Cipla Ltd / 62261, 85288 / Deficiency Letter
81. / Cipla Ltd / 62262, 85277 / Deficiency Letter
82. / Cipla Ltd / 64462, 88245 / Deficiency Letter
83. / Cipla Ltd / 67586, 84390 / Deficiency Letter
84. / Dr. Reddy’s Laboratories Ltd / 60457, 83451 / Deficiency Letter
85. / Emcure Pharmaceuticals Ltd / 64678, 88809 / Deficiency Letter
86. / Fresenius Kabi Oncology Ltd / 62557, 85836 / Deficiency Letter
87. / Glenmark Generics Ltd / 61914, 84694 / Deficiency Letter
88. / Hospira Healthcare India Pvt Ltd / 60968, 83800 / Deficiency Letter
89. / Shasun Pharmaceuticals Ltd / 63428, 87258 / Deficiency Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. Zuventus Healthcare / - / Approval Letter (2)
2. / M/s. Boehringer / - / Clarification Letter (2)
3. / M/s. Johnson & Johnson / - / Clarification Letter
4. / Dr. Saibal Mukhopadhyay, G.B. Pant / - / Approval Letter
5. / M/s. MSN Lab. / - / Clarification Letter (2)
6. / M/s. Intas Pharmaceuticals / - / Clarification Letter
7. / Dr. Ramchander, LHM / - / Clarification Letter
8. / Dr. M.S. Gopalakrishnan / - / Clarification Letter
VACCINE DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s Merck Specialities Pvt Ltd / 57666 / Approval letter
2 / M/s Cadila Healthcare Ltd / 57871 / Clarification Letter
3 / M/s Shantha Biotechnics Ltd / 55629 / Approval letter
4 / M/s MSD Pharmaceuticals pvt, Ltd / 60687 / Approval letter
5 / M/s Serum Institute of India Pvt, ltd / 59778 / Approval letter
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 / 58961 / Approval Letter
2. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 34107 / Approval Letter
3. / M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 56902 / Approval Letter
4. / M/s. APL Research Centre, Hyderabad-500 072 / 55957 / Amendment Letter
5. / M/s. APL Research Centre, Hyderabad-500 090 / 59365 / Approval Letter
6. / M/s. APL Research Centre, Hyderabad-500 090 / 58064 / Approval Letter
7. / M/s. APL Research Centre, Hyderabad-500 090 / 53830 / Amendment Letter
8. / M/s. APL Research Centre, Hyderabad-500 090 / 58454 / Amendment Letter
9. / M/s. APL Research Centre, Hyderabad-500 090 / 52446 / Amendment Letter
10. / M/s. APL Research Centre, Hyderabad-500 090 / 58064 / Clarification Letter
11. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 57879 / Approval Letter
12. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 56721 / Approval Letter
13. / M/s. Cliantha Research Limited, Ahmedabad-380 054 / 56672 / Additional Study Centre
14. / M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 28494 / Clarification Letter
15. / M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 / 39812 / Approval Letter
16. / M/s. Lupin Bioresearch Center, Pune-411 021 / 59451 / Clarification Letter
17. / M/s. Macleods Pharmaceuticals Ltd., Andheri (East), Mumbai-400 059 / 59735 / Clarification Letter
18. / M/s. Manipal Acunova KMC Clinical Pharmacology Unit, Mangalore-575 001 / 58951 / Approval Letter
19. / M/s. Micro Therapeutic Research Labs Pvt. Ltd., Chennai-600 059 / 56627 / Clarification Letter
20. / M/s. Mylan Laboratories Limited, Hyderabad-500 003 / 39854 / Approval Letter
21. / M/s. Mylan Laboratories Limited, Hyderabad-500 034 / 51751 / Amendment Letter
22. / M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai-400 701 / 56234 / Amendment Letter
23. / M/s. Wockhardt CPB, Clinical Pharmacokinetics and Biopharmaceuties Dept., Aurangabad-431 210 / 50119 / Approval Letter
SUBSEQUENT NEW DRUGS
S.No. / Name Of the Firm / Ref. No / FTS / Type of letter1. / M/s NU Therapeutic / 59975 / 81630 / Deficiency Letter
2. / M/s Zim Lab / 63717 / - / Approval Letter
3. / M/s Intas Pharma / - / - / Approval Letter
4. / M/s Symbiotic Drugs / 48563 / 71434 / Deficiency Letter
5. / M/s Selvok / 28981 / 40757 / Deficiency Letter
6. / M/s Healer’s Lab / 49608 / 69216 / Deficiency Letter
7. / M/s Torrent Pharma / 53353 / 73046 / Letter
LVP DIVISION
S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS01 / M/s. Akums Drugs & Pharmaceuticals Ltd., Uttarakhand / 87367 / Approval
02 / M/s. Marck Biosciences Ltd., Gujarat / 87049 / Approval
03 / M/s. Onco Therapies Ltd., Bangalore / 76373 / Approval
04 / M/s. Axa Parenterals, Uttarakhand / 87419 / Query
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference no. / Type of Letter1. / M/s. Apothecaries / 17417 / Clarification Letter
2. / M/s. Max neeman / 64187 / Clarification Letter
3. / M/s. Excel Life Sciences / 48207 / Clarification Letter
4. / M/s. Boehringer / 47334,50771 / TL Approval Letters
5. / M/s. BMS / 38763 / TL Approval Letter
6. / M/s. Parexel / 52865 / PA, TL Approval Letters