LETTERS FOR ISSUE ON 07.03.2014
VACCINE DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Human Biologicals Institute / 55719, 55724, 55721 / Clarification letter
2 / M/s Globion India Pvt, Ltd / Clarification letter
3 / M/s Pfizer Product India Pvt, Ltd / 5793 / Clarification letter
4 / M/s Sandor medicaids Pvt, Tld / 7528 / Clarification letter
5 / M/s Cliantha Research Ltd / 5441 / Approval Letter
6 / M/s Plasmagen Biosciences Pvt, Ltd / Approval Letter
7 / M/s Shantha Biotechnics Ltd / 5601, 8087, / Approval Letter
EXPORT OF BIOLOGICAL DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Cliantha Research Ltd / 7228, 6864, 7227, 6865, 6866 / Approval Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Japshi Chem Pharmaceuticals, / 82926 / Clarification Letter
2. / M/s. Japshi Chem Pharmaceuticals, / 82926 / Clarification Letter
3. / M/s. Zest Pharma, / 64445 / Clarification Letter
4. / M/s. D.M. Pharma / 49466 / Clarification Letter
5. / M/s. Merck Ltd., / 3465 / Letter
6. / M/s. Akums Drugs & Pharmaceuticals Ltd., / 37449 / Clarification Letter
7. / M/s. Corona Remedies Pvt. Ltd., / 42259 / Clarification Letter
8. / M/s. Appasamy Ocular Devices Pvt. Ltd., / 49379 / Clarification Letter
9. / M/s. Glenmark Pharmaceuticals / 65396 / Letter
10. / M/s. Symbiotic Drugs & Dibetic Care Pvt. Ltd., / 48564 / Clarification Letter
11. / M/s. Mankind Pharma Ltd., / 41550 / Clarification Letter
12. / M/s. Sun Pharmaceuticals / 1662 / Clarification Letter
13. / M/s. Cris Pharma (I) Ltd., / 42418 / Clarification Letter
14. / M/s. Sain Medicaments Pvt. Ltd., / 49718 / Clarification Letter
15. / M/s. Intas Pharmaceuticals Ltd., / 39211 / Letter
16. / M/s. FDC Limited / 39211 / Letter
17. / M/s. Centaur Pharmaceuticals Pvt. Ltd., / 39211 / Letter
BIOLOGICAL DIVISION DIVISION
S. No. / COMPANY NAME / Dy.No. / STATUS1 / M/s Cadila Healthcare Ltd / 576, 11715 (fts no) / Approval Letter
2 / M/s Serum Instiute of India Ltd / 11715 (fts no) / Approval Letter
3 / M/s Chirong Behring Vaccine Pvt, Ltd / 6381 (fts no) / Approval Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Biomet Orthopaedic India Pvt. Ltd. / 61840 / Approval (F-RC)
2. / M/s. C. Natvarlal& Co. / 57229 / Approval (F-RC)
3. / M/s. Baxter (India) Pvt. Ltd. / 3125 / Approval (R-RC)
4. / M/s. Biomet Orthopaedic India Pvt. Ltd. / 61840 / Approval (F-IL)
5. / M/s. Abbott Medical Optics Pvt. Ltd. / 5934 / Approval (R-IL)
6. / M/s. Baxter (India) Pvt. Ltd. / 3125 / Approval (R-IL)
7. / M/s. Baxter (India) Pvt. Ltd. / 2071 / Approval (R-IL)
8. / M/s. Surgimedik Healthcare. / FTS-4388 / Clarification Letter
9. / Mr. AnkurMaheshwari, U.P. / FTS-9629 / Clarification Letter
10. / M/s. Alcon Laboratories (India) Pvt. Ltd / 4281 / Clarification Letter
11. / M/s. B. Braun Medical (India) Pvt. Ltd. / 2631 / Clarification Letter
12. / M/s. B. Braun Medical (India) Pvt. Ltd. / 1101 / Clarification Letter
13. / M/s. Covidien Healthcare India Pvt. Ltd. / 43993 / Clarification Letter
14. / M/s. India Medtronic Pvt. Ltd. / 37976 / Clarification Letter
15. / M/s. Jindal Enterprises. / 3806 / Clarification Letter
16. / M/s. Mn Solutions. / 44793 / Clarification Letter
DIAGNOSTICS DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Amar Immunodiagnostics. / 2908 / Approval (IL)
2. / M/s. Abbott Healthcare Pvt. Ltd. / 1397 / Approval (IL)
3. / M/s. KDH Biomedicals Pvt. Ltd. / 3416 / Approval (IL)
4. / M/s. A & A Enterprises. / 2834 / Approval (E-IL)
5. / M/s. Roche Diagnostics India Pvt. Ltd. / 2803 / Approval (E-IL)
6. / M/s. Werfen Medical India Pvt. Ltd. / 1554 / Approval (E-IL)
7. / M/s. Johnson & Johnson Ltd. / 3202 / Approval Letter
TEST LICENCES
S. No. / Name of the Company / Diary No. / Type of Letter1. / Alkem Laboratories Ltd / 5320, 8357 / Approval Letter
2. / Alkem Laboratories Ltd / 5319, 8352 / Approval Letter
3. / Alkem Laboratories Ltd / 5318, 8351 / Approval Letter
4. / Alkem Laboratories Ltd / 5317, 8347 / Approval Letter
5. / Alkem Laboratories Ltd / 5316, 8341 / Approval Letter
6. / Alkem Laboratories Ltd / 5315, 8340 / Approval Letter
7. / Apotex Research Pvt. Ltd / 5269, 8254 / Approval Letter
8. / Apotex Research Pvt. Ltd / 5270, 8250 / Approval Letter
9. / Apotex Research Pvt. Ltd / 5271, 8243 / Approval Letter
10. / Apotex Research Pvt. Ltd / 5268, 8260 / Approval Letter
11. / Apotex Research Pvt. Ltd / 5267, 8267 / Approval Letter
12. / Apotex Research Pvt. Ltd / 5266, 8272 / Approval Letter
13. / Apotex Research Pvt. Ltd / 5265, 8278 / Approval Letter
14. / Apotex Research Pvt. Ltd / 5264, 8281 / Approval Letter
15. / Cipla Ltd / 5367, 8291 / Approval Letter
16. / Cipla Ltd / 5368, 8297 / Approval Letter
17. / Dr. Reddy’s Laboratories Ltd / 5305, 8373 / Approval Letter
18. / Dr. Reddy’s Laboratories Ltd / 5303, 8380 / Approval Letter
19. / Dr. Reddy’s Laboratories Ltd / 5302, 8383 / Approval Letter
20. / Dr. Reddy’s Laboratories Ltd / 5304, 8376 / Approval Letter
21. / Glenmark Generics Ltd / 5600, 8634 / Approval Letter
22. / Glenmark Generics Ltd / 5593, 8899 / Approval Letter
23. / Glenmark Pharmaceuticals Ltd / 5594, 8897 / Approval Letter
24. / Glenmark Pharmaceuticals Ltd / 5595, 8894 / Approval Letter
25. / Glenmark Pharmaceuticals Ltd / 5596, 8893 / Approval Letter
26. / Inventia Healthcare Pvt. Ltd / 5250, 8366 / Approval Letter
27. / Macleods Pharmaceuticals Ltd / 5770, 9218 / Approval Letter
28. / Macleods Pharmaceuticals Ltd / 5769, 9220 / Approval Letter
29. / Sandoz Pvt. Ltd / 5255, 8332 / Approval Letter
30. / Sanofi-Synthelabo (India) Ltd / 5351, 8304 / Approval Letter
31. / Torrent Pharmaceuticals Ltd / 5782, 9133 / Approval Letter
32. / Unichem Laboratories Ltd / 5927, 9222 / Approval Letter
33. / Unichem Laboratories Ltd / 5926, 9225 / Approval Letter
34. / Unichem Laboratories Ltd / 5924, 9227 / Approval Letter
35. / Unichem Laboratories Ltd / 5925, 9226 / Approval Letter
36. / Unichem Laboratories Ltd / 5923, 9228 / Approval Letter
37. / Unichem Laboratories Ltd / 5922, 9230 / Approval Letter
38. / Unichem Laboratories Ltd / 5933, 9232 / Approval Letter
39. / Unichem Laboratories Ltd / 5888, 9245 / Approval Letter
40. / Unichem Laboratories Ltd / 5889, 9244 / Approval Letter
41. / Unichem Laboratories Ltd / 5890, 9242 / Approval Letter
42. / Unichem Laboratories Ltd / 5928, 9239 / Approval Letter
43. / Unichem Laboratories Ltd / 5929, 9238 / Approval Letter
44. / Unichem Laboratories Ltd / 5930, 9236 / Approval Letter
45. / Unichem Laboratories Ltd / 5931, 9234 / Approval Letter
46. / Unichem Laboratories Ltd / 5880, 9251 / Approval Letter
47. / Unichem Laboratories Ltd / 5881, 9250 / Approval Letter
48. / Unichem Laboratories Ltd / 5882, 9248 / Approval Letter
REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / WIPRO GE HELATHCARE PVT. LTD. / 908 / APPROVAL LETTER
2. / ZOETIS INDIA LTD. / 53093 / CLARIFICATION LETTER
3. / SANOFI-SYNTHELABO(INDIA) LTD. / 57047 / CLARIFICATION LETTER
4. / DSM SINOCHEM PHARMACEUTICALS INDIA PVT. LTD. / 59672 / CLARIFICATION LETTER
SHELF LIFE
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / GLENMARK PHARMACEUTICALS LTD. / 2819 / APPROVAL LETTER
2. / MANEESH EXPORT / NIL / CALRIFICATION LETTER
IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Tablets (India) Ltd. / 253 / Approval Letter
2. / Micro Labs Ltd. / 6055 / Approval Letter
3. / Medi Pharma Drug House / 4851 / Approval Letter
4. / Indi Pharma Pvt.Ltd. / 3912 / Approval Letter
5. / Shamshree International Pvt. Ltd. / 3801 / Approval Letter
6. / K.Sevantilal & Co. / 3762 / Approval Letter
7. / B.M. Chemie / 3817 / Approval Letter
8. / Gorang International / 3819 / Approval Letter
9. / Gorang International / 3820 / Approval Letter
10. / Gorang International / 3818 / Approval Letter
11. / RPG Life Sciences Ltd. / 4131 / Approval Letter
12. / Ind-Swift Laboratories Limited / 4017 / Approval Letter
13. / Torrent Pharamceuticals Ltd. / 4017 / Approval Letter
14. / Torrent Pharmaceuticals Ltd. / 3993 / Approval Letter
15. / Farmachem Life Pvt. Ltd. / 4041 / Approval Letter
16. / Farmachem Life Pvt. Ltd. / 4040 / Approval Letter
17. / Ruskin Chemipharm / 4039 / Approval Letter
18. / Macleods Pharmaceuticals Limited / 4042 / Approval Letter
19. / Sun Pharma Laboratories Ltd. / 4074 / Approval Letter
20. / Sun Pharma Laboratories Ltd. / 4072 / Approval Letter
21. / Sun Pharmaceutical Industries Ltd., / 4073 / Approval Letter
22. / GSK Pharmaceuticals Ltd. / 7853 / Approval Letter
23. / Pfizer Ltd. / 7081 / Approval Letter
24. / Pfizer Products India Pvt. Ltd. / 7080 / Approval Letter
25. / LG Life Sciences India Private Ltd. / 4087 / Approval Letter
26. / LG Life Sciences India Private Ltd. / 4088 / Approval Letter
27. / Shell-Life Sciences Pvt. Ltd. / 4252 / Approval Letter
28. / Pratistha Pharma, / 4254 / Approval Letter
29. / Scott Edil Pharmacia Ltd. / 4291 / Approval Letter
30. / Shell-Life Sciences Pvt. Ltd. / 4243 / Approval Letter
31. / LOK-BETA Pharmaceuticals(I) Pvt. Ltd. / 4274 / Approval Letter
32. / Alembic Pharmaceuticals Ltd., / 4278 / Approval Letter
33. / Wockhardt Limited / 4552 / Approval Letter
34. / Ajanta Pharma Ltd. / 4578 / Approval Letter
35. / Ind-Swift Laboratories Limited / 4499 / Approval Letter
36. / Pratistha Pharma, / 4500 / Approval Letter
37. / Glenmark Pharmaceuticals Ltd. / 4628 / Approval Letter
38. / Glenmark Pharmaceuticals Ltd. / 4629 / Approval Letter
39. / Raj Impex / 4615 / Approval Letter
40. / Unimed Technologies Ltd. / 4536 / Approval Letter
41. / Zuventus Healthcare Ltd. / 4596 / Approval Letter
42. / Wyeht Ltd. / 6804 / Approval Letter
43. / Health 'N' U Therapeutics Pvt. Ltd. / 4751 / Approval Letter
44. / Cipla Ltd. / 4798 / Approval Letter
45. / Cipla Ltd. / 4797 / Approval Letter
46. / Maneesh Pharmaceuticals Ltd. / 4724 / Approval Letter
47. / Medi Pharma Drug House / 4854 / Approval Letter
48. / Medi Pharma Drug House / 4852 / Approval Letter
49. / Medi Pharma Drug House / 4853 / Approval Letter
50. / Medi Pharma Drug House / 4855 / Approval Letter
51. / Vital Healhtcare Pvt. Ltd. / 4701 / Approval Letter
52. / Indoco Remedies Ltd.(Plant II) / 4873 / Approval Letter
53. / Aril Pharmaceuticals / 4849 / Approval Letter
54. / Chandra Bhagat Pharma Pvt. Ltd. / 4809 / Approval Letter
55. / Supreem Pharmaceuticals Mysore Pvt. Ltd. / 4850 / Approval Letter
56. / Bharat Serums And Vaccines Ltd. / 4957 / Approval Letter
57. / Harshada Corporation, / 4958 / Approval Letter
58. / Pfizer Ltd., / 5053 / Approval Letter
59. / Pfizer Ltd. / 5051 / Approval Letter
60. / Wyeth Ltd. / 5052 / Approval Letter
61. / Sagar Rubber Products Pvt. Ltd. / 4964 / Approval Letter
62. / Glenmark Pharmaceuticals Ltd. / 5039 / Approval Letter
63. / Glenmark Pharmaceuticals Ltd. / 5038 / Approval Letter
64. / Glenmark Pharmaceuticals Ltd. / 5040 / Approval Letter
65. / VHB MEDI SCEINCES LTD. / 4725 / AMENDED LETTER
66. / RUSKIN CHEMIPHARM / 5059 / AMENDED LETTER