LETTERS FOR ISSUE ON 03.02.2014
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / M/s. MSN Laboratories Ltd. / - / Approval Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Sun Pharmaceuticals Industries Ltd., / 60913 / 2 Amendment Letter
2. / M/s. Famy Care Ltd., / 58226 / Approval Letter
LETTER PERTAINING TO IMPORT
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / BAYER ZYDUS PHARMA PVT. LTD. / 6317 / CLARIFICATION LETTER
2. / BRISTOL MYERS SQUIBB INDIAN PVT LTD. / 52117 / CLARIFICATION LETTER
3. / Venus Remedies Ltd. / NIL / REMINDER LETTER
4. / Turakhia Brothers / NIL / REMINDER LETTER
5. / Cadila Pharmaceuticals Ltd. / NIL / REMINDER LETTER
6. / Sheetal Pharma, / NIL / REMINDER LETTER
7. / Sheetal Pharma, / NIL / REMINDER LETTER
8. / Sheetal Pharma, / NIL / REMINDER LETTER
9. / Unimark Remedies Ltd. / NIL / REMINDER LETTER
10. / Ind-Swift Laboratories Ltd. / NIL / REMINDER LETTER
11. / Dilipkumar & Co. / NIL / REMINDER LETTER
12. / General Import Co. (I) Pvt. Ltd. / NIL / REMINDER LETTER
13. / Pratistha Pharma / NIL / REMINDER LETTER
14. / Pratistha Pharma / NIL / REMINDER LETTER
15. / Pratistha Pharma / NIL / REMINDER LETTER
16. / Pratistha Pharma / NIL / REMINDER LETTER
17. / Nischem International / NIL / REMINDER LETTER
18. / Unimark Remedies Ltd. / NIL / REMINDER LETTER
19. / Cadila Pharmaceuticals Ltd. / NIL / REMINDER LETTER
20. / Indian Immunologicals Ltd. / NIL / REMINDER LETTER
21. / Unimark Remedies Ltd. / NIL / REMINDER LETTER
22. / Medopharm / NIL / REMINDER LETTER
23. / Micro Labs Ltd. / NIL / REMINDER LETTER
24. / Sheetal Pharma, / NIL / REMINDER LETTER
25. / Mankind Pharma / NIL / REMINDER LETTER
26. / Concept Pharamceuticals Ltd. / NIL / REMINDER LETTER
27. / FDC Ltd. / NIL / REMINDER LETTER
28. / Abbott Healthcare Pvt. Ltd. / NIL / REMINDER LETTER
29. / Pradipkumar & Co. / NIL / REMINDER LETTER
30. / Biochem Pharmaceuticals Industries Ltd. / NIL / REMINDER LETTER
31. / Cadila Pharmaceuticals Ltd. / NIL / REMINDER LETTER
32. / Biocon Ltd. / NIL / REMINDER LETTER
33. / Pratistha Pharma / NIL / REMINDER LETTER
34. / Gufic Biosceinces Ltd. / NIL / REMINDER LETTER
35. / Windlas Helathcare Pvt. Ltd. / NIL / REMINDER LETTER
36. / General Import Co. (I) Pvt. Ltd. / NIL / REMINDER LETTER
37. / Ind-Swift Laboratories Ltd. / NIL / REMINDER LETTER
38. / Unimed Technologies Ltd. / NIL / REMINDER LETTER
39. / Venky's India Ltd. / NIL / REMINDER LETTER
40. / Alkem Laboratories / NIL / REMINDER LETTER
41. / Astrazeneca Pharma India Ltd. / NIL / REMINDER LETTER
42. / Sunways (I) Pvt. Ltd. / NIL / REMINDER LETTER
43. / Sunways (I) Pvt. Ltd. / NIL / REMINDER LETTER
44. / Biocon Pharmaceuticals Pvt. Ltd. / NIL / REMINDER LETTER
45. / Impex Oversease / NIL / REMINDER LETTER
46. / Innovative Healthcare India Pvt. Ltd. / NIL / REMINDER LETTER
47. / Innovative Healthcare India Pvt. Ltd. / NIL / REMINDER LETTER
48. / MSD Pharmaceuticals Pvt. Ltd. / NIL / REMINDER LETTER
49. / National Pharma / NIL / REMINDER LETTER
50. / Zen Enterprises / NIL / REMINDER LETTER
51. / Alto Medical Systems Pvt. Ltd. / NIL / REMINDER LETTER
52. / Vibgyor Enterprises / NIL / REMINDER LETTER
53. / Alto Medical Systems Pvt. Ltd. / NIL / REMINDER LETTER
54. / Zen Enterprises / NIL / REMINDER LETTER
55. / Samrath Lifesciences Pvt. Ltd. / NIL / REMINDER LETTER
56. / Indi Pharma Pvt. Ltd. / NIL / REMINDER LETTER
57. / Medi pharma Drug House / NIL / REMINDER LETTER
58. / G.C. Chemie Pharmie Ltd. / NIL / REMINDER LETTER
59. / ANG Lifesciences Pvt. Ltd. / NIL / REMINDER LETTER
60. / Ranbaxy Laboratories Ltd. / NIL / REMINDER LETTER
61. / Promed Export Pvt. Ltd. / NIL / REMINDER LETTER
62. / Vibgyor Enterprises / NIL / REMINDER LETTER
63. / United Agencies, / NIL / REMINDER LETTER
64. / Baxter India Pvt. Ltd. / NIL / REMINDER LETTER
65. / Baxter India Pvt. Ltd. / NIL / REMINDER LETTER
66. / National Pharma / NIL / REMINDER LETTER
67. / Pfizer Products India Pvt. Ltd. / NIL / REMINDER LETTER
68. / Piramal Healthcare Ltd. / NIL / REMINDER LETTER
69. / Cipla Ltd. / NIL / REMINDER LETTER
70. / Pharmachem / NIL / REMINDER LETTER
71. / Keyur Pharmachem india Pvt. Ltd. / NIL / REMINDER LETTER
LETTERS PERTAINING TO MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. DJO Global India Healthcare Pvt. Ltd. / 28928 / Approval (F-RC)
2. / M/s. Dr. Reddy Laboratories Ltd. / 65071 / Approval (F-RC)
3. / M/s. Johnson & Johnson Ltd. / 64267 / Approval (F-RC)
4. / M/s. Shreyaas Health Care. / 54875 / Approval (F-RC)
5. / M/s. Translumina Therapeutics LLP. / 53172 / Approval (F-RC)
6. / M/s. Biosensors Interventional Technologies (India) Pvt. Ltd. / 965 / Approval (R-RC)
7. / M/s. Bard India Healthcare Pvt. Ltd. / 63587 / Approval (R-E-RC)
8. / M/s. Boston Scientific India Pvt. Ltd. / 54238 / Approval (R-E-RC)
9. / M/s. BioradMedisys Pvt. Ltd. / 33791 / Approval (F-IL)
10. / M/s. Johnson & Johnson Ltd. / 64267 / Approval (F-IL)
11. / M/s. Meril Life Sciences India Pvt. Ltd. / 53710 / Approval (F-IL)
12. / M/s. Shreyass Health Care. / 63234 / Approval (F-IL)
13. / M/s. Neo Alliance Healthcare Technologies Pvt. Ltd. / 3248 / Approval (R-IL)
14. / M/s. Boston Scientific India Pvt. Ltd. / 27125 / Approval (R-E-IL)
15. / The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Gujarat (CLAA)
(M/s. Meril Life Sciences Pvt. Ltd. Vapi) / 764 / Approval Letter
16. / The Deputy Drugs Controller (I), Ghaziabad (CLAA)
The State Drugs Controller, Haryana (CLAA)
M/s. Degania Medical Devices Pvt. Ltd., Haryana (CLAA) / 55438 / Clarification Letter
17. / M/s. Genius Ortho Pvt. Ltd. (CLAA) / FTS-74514 / Clarification Letter
18. / M/s. Meril Life Sciences Pvt. Ltd., (CLAA)
The Commissioner, Gujarat (CLAA)
The Deputy Drugs Controller (I), Gujarat (CLAA) / 763 / Clarification Letter
19. / M/s. Emergo (India) Consulting Pvt. Ltd. / 11746 / Clarification Letter
20. / M/s. Regenerative Medical Service Pvt. Ltd. / 62870 / Clarification Letter
21. / Prof. Shailesh B Gaikwad, New Delhi. / 74706 / Clarification Letter
22. / All Port Offices of CDSCO.
M/s. Thermogenesis Corp., USA / Nil / Clarification Letter
LETTERS PERTAINING TO DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Diagast Gurgaon. / 60062 / Approval (E-IL)
2. / M/s. Apex Diagnostics. / 61796 / Clarification Letter
3. / M/s. Abbott Healthcare Pvt. Ltd. / 428 / Clarification Letter
4. / M/s. Bharat Serums & Vaccines Ltd. / 464 / Clarification Letter
5. / M/s. Bhat Bio-Tech India (P) Ltd. / 709 / Clarification Letter
6. / M/s. Immucor India Pvt. Ltd. / 62212 / Clarification Letter
7. / M/s. Roche Diagnostics India Pvt. Ltd. / 60335 / Clarification Letter
8. / M/s. Reckon Diagnostics Pvt. Ltd. / 807 / Clarification Letter
9. / M/s. Weldon Biotech (India) Pvt. Ltd. / 62665 / Clarification Letter
VACCCINE DIVISION
Sr. No. / Company Name / Dy. No. / STATUS1 / M/s Intervet India Pvt, Ltd / 44173 / Approval Letter
2 / M/s Reliance Life Sciences Pvt, Ltd / 1155 / Clarification Letter
3 / M/s Indian Immunologicals Ltd / 56443 / Clarification Letter
BA-BE CENTRE
S. No / Firm Name / D. No / Type of Letter1. / M/s. Manipal Acunova KH Clinical Resarch Centre., / Nil / Letter
2. / M/s. Mylan Laboratories Ltd., / Nil / Letter
3. / M/s. Clinse Labs Pvt. Ltd., / Nil / Letter
4-5 / M/s. Qauntimmune Solutions Pvt. Ltd., / Nil / Letter
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference no. / Type of Letter1. / M/s. Sanofi Pasteur / - / Clarification Letter
2. / M/s. Novartis / 19339,19814 / Clarification Letter
3. / M/s. Amgen / 48207 / Clarification Letter
4. / M/s. Pharmanet / 42993 / Clarification Letter
BE NOC FOR EXPORT
S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter1. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 24095 / Clarification Letter
2. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 22866 / Clarification Letter
3. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 26978 / Clarification Letter
4. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 38114 / Clarification Letter
5. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad-380 015 / 25960 / Clarification Letter
6. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 51065 / Clarification Letter
7. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 45769 / Clarification Letter
8. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 46305 / Clarification Letter
9. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 42352 / Clarification Letter
10. / M/s. Accutest Research Laboratories (I) Pvt. Ltd., Navi Mumbai-400 709 / 37814 / Clarification Letter
11. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 26242 / Clarification Letter
12. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 52475 / Clarification Letter
13. / M/s. Aizant Drug Research Solutions Pvt. Ltd., Hyderabad-500 014 / 9655 / Clarification Letter
14. / M/s. Alembic Ltd., Vadodara-390 003 / 29928 / Clarification Letter
15. / M/s. Alembic Ltd., Vadodara-390 003 / FTS No. 64385 / Clarification Letter
16. / M/s. Alembic Ltd., Vadodara-390 003 / FTS No. 64393 / Clarification Letter
17. / M/s. Alembic Ltd., Vadodara-390 003 / 64378 / Clarification Letter
18. / M/s. Alembic Ltd., Vadodara-390 003 / 37612 / Clarification Letter
19. / M/s. Alembic Ltd., Vadodara-390 003 / 24051 / Clarification Letter
20. / M/s. Alembic Ltd., Vadodara-390 003 / 15859 / Clarification Letter
21. / M/s. Alembic Ltd., Vadodara-390 003 / 37610 / Clarification Letter
22. / M/s. Alembic Ltd., Vadodara-390 003 / 64391 / Clarification Letter
23. / M/s. Alembic Ltd., Vadodara-390 003 / 20028 / Clarification Letter
24. / M/s. Alkem Laboratories Ltd., Patna-800 001 / 14753 / Clarification Letter
25. / M/s. APL Research Center, Hyderabad-500 038 / 43511 / Clarification Letter
26. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 29828 / Clarification Letter
27. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 3160 / Clarification Letter
28. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 35792 / Clarification Letter
29. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 34777 / Clarification Letter
30. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 35789 / Clarification Letter
31. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 24790 / Clarification Letter
32. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 43792 / Clarification Letter
33. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 24888 / Clarification Letter
34. / M/s. Apotex Research Pvt. Ltd., Bangalore-560 099 / 6233 / Clarification Letter
35. / M/s. Ashco Niulab Industries Ltd., Mumbai-400 093 / 31565 / Clarification Letter
36. / M/s. Ashco Niulab Industries Ltd., Mumbai-400 093 / 14074 / Clarification Letter
37. / M/s. Axis Clinicals Ltd., Hyderabad-500 049 / 41372 / Clarification Letter
38. / M/s. Azidus Laboratories Ltd., Chennai-600 048 / 40426 / Clarification Letter
39. / M/s. Cipla Ltd., Mumbai-400 008 / 42717 / Clarification Letter
40. / M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 5720 / Clarification Letter
41. / M/s. Dr. Reddy's Laboratories Ltd., Hyderabad-500 016 / 28210 / Clarification Letter
42. / M/s. Famy Care Ltd., Navi Mumbai-400 709 / 22268 / Clarification Letter
43. / M/s. Fortis Clinical Research Ltd., Faridabad-121 002, Haryana / 26128 / Clarification Letter
44. / M/s. Fresenius Kabi Oncology Ltd., Gurgaon-122 001, Haryana / 32408 / Clarification Letter
45. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 14867 / Clarification Letter
46. / M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 038 / 47040 / Clarification Letter
47. / M/s. Hetero Labs Ltd., Hyderabad-500 018 / 44328 / Clarification Letter
48. / M/s. Intas Pharmaceuticals Ltd., Ahmedabad-380 009 / 45445 / Clarification Letter
49. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 42201 / Clarification Letter
50. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 49251 / Clarification Letter
51. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 37628 / Clarification Letter
52. / M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 30692 / Clarification Letter
53. / M/s. Lupin Bioresearch Centre, Pune-411 021 / 23576 / Clarification Letter
54. / M/s. Manipal Acunova Ltd., Bangalore-560 066 / 1653 / Clarification Letter
55. / M/s. Manipal Acunova Ltd., Bangalore-560 066 / 3157 / Clarification Letter
56. / M/s. Manipal Acunova Ltd., Bangalore-560 066 / 2283 / Clarification Letter
57. / M/s. Matrix Laboratories Ltd., Secunderabad-500 003 / 48447 / Clarification Letter
58. / M/s. Mylan Laboratories Ltd., Medak District -502 325, AP / 11219 / Clarification Letter
59. / M/s. Piramal Clinical Research, Hyderabad-500 013 / 18615 / Clarification Letter
60. / M/s. RA Chem Pharma Ltd., Hyderabad-500 037 / 56903 / Clarification Letter