Letters for Issue on 12.09.2014

LETTERS FOR ISSUE ON 12.09.2014 VACCINE DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s Bharat Biotech 30861, 30860 Clarification Letter International Ltd

2 M/s Intervet India Pvt, ltd 20336 Clarification Letter

3 M/s Shantha Biotechnices Ltd 26138 Clarification Letter

4 M/s Biovet Pvt, ltd 25344 Clarification Letter

5 M/s Human Biological Clarification Letter Institute

6 M/s Sun Pharmaceuticals 29424, 53051 Approval letter Industries Ltd

7 M/s Biological E. Ltd 35651 Acknowledge Letter BIOLOGICAL DIVISION

S. No. COMPANY NAME Dy.No. STATUS

1 M/s Shantha Biotechnices 31669 Approval letter Ltd

2 M/s Hemarus Therapeutics 6891 Approval letter Ltd

3 M/s Lupin Ltd 63515 Approval letter

4 M/s Sanofi Synthelabo India 35330, 35329, 3532 Approval letter Ltd

5 M/s Kemwell Biopharma Pvt, 31669 Approval letter ltd IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. PFIZER LTD. 36402 AMENDED LETTER/ CLARIFICATION LETTER 2. PARABOLIC DRUGS CO. LTD. 25713 CLARIFICATION LETTER 3. COVALENT LABORATOREIS 25938 CLARIFICATION PVT. LTD. LETTER 4. KOPRAN LTD. 26276 CLARIFICATION LETTER 5. KANTILAL MANILAL & Co. Pvt. 26842 CLARIFICATION Ltd. LETTER 6. VENUS REMEDIES LTD. 27150 CLARIFICATION LETTER 7. CADILA HELATHCARE LTD. 30443,30444 2 CLARIFICATION LETTER 8. HARESH CHEMICALS 31535 CLARIFICATION LETTER 9. BHARAT SERUMS AND 37625 CLARIFICATION VACCINES LTD. LETTER 10. MEDREICH LTD. 37675 CLARIFICATION LETTER REGISTRATION

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. G.C. CHEMIE PHARMIE LTD. 5287 APPROVAL LETTER 2. DSM NUTRITIONAL PRODUCTS 24993 APPROVAL LETTER INDIA PVT. LTD. 3. RUSKIN CHEMIPHARMA NIL CLARIFICATION LETTER 4. PFIZER LTD. 17205 CLARIFICATION LETTER 5. FRESENIUS KABI INDIA PVT 31978 CLARIFICATION LTD. LETTER SHELF LIFE/MISC.

S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. MANEESH EXPORT NIL CLARIFICATION LETTER 2. STRIDES ARCOLAB LTD. 24364 CLARIFICATION LETTER GLOBAL CLINICAL TRIAL

Sr. No. Name of Firm Reference No. Type of Letter

1. M/s.Amgen 30689 TL Approval Letter

2. M/s. Pfizer 32262/35565 TL Approval letter/Clarification Letter

3. M/s. Novartis 33023 Clarification Letter

4. M/s. Kendle 34095 Clarification Letter

SUBSEQUENT NEW DRUG S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO.

1. M/s Akums Drugs 52161 - Approval Letter

2. M/s Dr. Willmar 39721 - Approval Letter Schwabe

MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Teleflex Medical Pvt. Ltd. 28209 Approval (F-RC)

2. M/s. Bangalore Surgicals. 26617 Approval (F-IL)

3. M/s. BSN Medical Pvt. Ltd. 32751 Approval (F-IL)

4. M/s. Centenial Surgical Suture Ltd. 31647 Approval (F-IL)

5. M/s. Edwards Lifesciences (India) Pvt. Ltd. 27069 Approval (E-IL)

6. M/s. St. Jude Medical India Pvt. Ltd. 29452 Approval (R-E-IL)

7. M/s. B. Braun Medical (India) Pvt. Ltd. 29393 Approval Letter

8. M/s. Edwards Life Sciences (India) Pvt. Ltd. 28899 Approval Letter 9. M/s. Travancore Trade Links. 22444 Approval Letter

10. M/s. St. Jude Medical India Pvt. Ltd. 29032 Approval Letter

11. M/s. Ossur Asia-The Swedish Trade & Invest FTS-22911 Clarification Letter Council.

12. M/s. Alcon Laboratories (India) Pvt. Ltd. 27113 Query Letter

13. M/s. Johnson & Johnson Ltd. 29505 Query Letter

DIAGNOSTIC DIVISION S.NO. COMPANY NAME DIARY NO STATUS

1. M/s. Diasorin Trivitron Health Care Pvt. Ltd. 30079 Approval (IL)

2. M/s. LabX. 27827 Approval (IL)

3. M/s. MHS Pharmaceuticals Pvt. Ltd. 33192 Approval (IL)

All port offices of CDSCO.

4. M/s. Sysmex India (P) Ltd. 28300 Approval (IL)

5. M/s. Roche Diagnostics India Pvt. Ltd. 28687 Approval Letter

6. M/s. Trivector Origio Scientific Pvt. Ltd. Nil Letter

Dr. Inder Prakash, DGHS, Nirman Bhawan.

7. M/s. DHR Holding India Pvt. Ltd. 32227 Query Letter

TEST LICENCES

S. No. Name of the Company Diary No. Type of Letter 1. Abbott India Ltd 36188, Approval Letter 53332 2. Akem Laboratories Ltd 35898, Approval Letter 52852 3. Alkem Laboratories Ltd 35897, Approval Letter 52847 4. Alkem Laboratories Ltd 35896, Approval Letter 52919 5. Alpha Pharma Healthcare (I) 35833, Approval Letter Pvt. Ltd 52889 6. Alphamed Formulations Pvt. 36198, Approval Letter Ltd 53388 7. Alphamed Formulations Pvt. 36199, Approval Letter Ltd 53391 8. Alphamed Formulations Pvt. 36200, Approval Letter Ltd 53398 9. Alphamed Formulations Pvt. 36201, Approval Letter Ltd 53402 10. Alphamed Formulations Pvt. 36202,534 Approval Letter Ltd 04 11. Alphamed Formulations Pvt. 36203, Approval Letter Ltd 53408 12. Alphamed Formulations Pvt. 36204, Approval Letter Ltd 53411 13. Alphamed Formulations Pvt. 36205, Approval Letter Ltd 53415 14. Amneal Pharmaceuticals 36207, Approval Letter Company (I) Pvt. Ltd 53373 15. AstraZeneca Pharma India Ltd 36141,532 Approval Letter 57 16. AstraZeneca Pharma India Ltd 36140, Approval Letter 53262 17. Athena Drug Delivery 35939, Approval Letter Solutions Pvt Ltd 52857 18. Dr. Reddy’s Laboratories Ltd 36059, Approval Letter 53197 19. Dr. Reddy’s Laboratories Ltd 36060, Approval Letter 53194 20. Dr. Reddy’s Laboratories Ltd 36061, Approval Letter 53190 21. Emcure Pharmaceuticals Ltd 35887, Approval Letter 52956 22. Emcure Pharmaceuticals Ltd 35889, Approval Letter 52947 23. Emcure Pharmaceuticals Ltd 35888, Approval Letter 52951 24. Emcure Pharmaceuticals Ltd 36111, Approval Letter 53443 25. Emcure Pharmaceuticals Ltd 36112, Approval Letter 53446 26. Emcure Pharmaceuticals Ltd 36110, Approval Letter 53448 27. Ferring Pharmaceuticals Pvt 36189, Approval Letter Ltd 53432 28. Ferring Pharmaceuticals Pvt 36190, Approval Letter Ltd 53436 29. Fresenius Kabi Oncology Ltd 35824, Approval Letter 52875 30. Getz Pharma Research Pvt Ltd 36014, Approval Letter 53300 31. Getz Pharma Research Pvt Ltd 36015, Approval Letter 53304 32. Glenmark Generics Ltd 36081, Approval Letter 53277 33. Hospira Healthcare India Pvt 35877, Approval Letter Ltd 52935 34. Hospira Healthcare India Pvt 35878, Approval Letter Ltd 52934 35. Indoco Remedies Ltd 35934, Approval Letter 52932 36. Indoco Remedies Ltd 35933, Approval Letter 52933 37. Intas Pharmaceuticals Ltd 35901, Approval Letter 52899 38. Intas Pharmaceuticals Ltd 35874, Approval Letter 52837 39. Intas Pharmaceuticals Ltd 35902, Approval Letter 52838 40. Inventia Healthcare Pvt Ltd 35838, Approval Letter 52812 41. Inventia Healthcare Pvt Ltd 35837, Approval Letter 52814 42. Johnson and Johnson Ltd 36193, Approval Letter 53252 43. Jubilant Generics Ltd 35875, Approval Letter 52864 44. Jubilant Generics Ltd 35876, Approval Letter 52860 45. Jubilant Generics Ltd 36016, Approval Letter 53309 46. Kusum Healthcare Pvt Ltd 36013, Approval Letter 53293 47. Lupin Ltd 36075, Approval Letter 53174 48. Lupin Ltd 36076, Approval Letter 53171 49. Lupin Ltd 36077, Approval Letter 53167 50. Lupin Ltd 36074, Approval Letter 53179 51. Lupin Ltd 36080, Approval Letter 53157 52. Lupin Ltd 36079, Approval Letter 53160 53. Lupin Ltd 36078, Approval Letter 53163 54. Natco Pharma Ltd 36187, Approval Letter 53340 55. Natco Pharma Ltd 36191, Approval Letter 53264 56. Natco Pharma Ltd 36192, Approval Letter 53272 57. Panacea Biotec Ltd 36208, Approval Letter 53255 58. Perrigo Laboratories India Pvt 35899, Approval Letter Ltd 52818 59. Piramal Enterprises Ltd 36109, Approval Letter 53326 60. Piramal Enterprises Ltd 35970, Approval Letter 52916 61. Rubicon Research Pvt Ltd 36146, Approval Letter 53155 62. Sanofi-Synthelabo (India) Ltd 36165, Approval Letter 53336 63. Sanofi-Synthelabo (India) Ltd 36167, Approval Letter 53343 64. Sanofi-Synthelabo (India) Ltd 36166, Approval Letter 53369 65. Sequent Scientific Ltd 35880, Approval Letter 52843 66. Shilpa Medicare Ltd 35944, Approval Letter 52842 67. Shilpa Medicare Ltd 35942, Approval Letter 52844 68. Shilpa Medicare Ltd 35943, Approval Letter 52849 69. Shilpa Medicare Ltd 35941, Approval Letter 52848 70. Shilpa Medicare Ltd 35945, Approval Letter 52845 71. Shilpa Medicare Ltd 35940, Approval Letter 52853 72. Sidmak Laboratories (India) 36021, Approval Letter Pvt. Ltd 53321 73. Strides Arcolab Ltd 35879, Approval Letter 52827 74. Sun Pharmaceutical Industries 35969, Approval Letter Ltd 52904 75. Sunglow Pharmaceuticals Pvt. 35823, Approval Letter Ltd 52882 76. Suven Life Science Ltd 36062, Approval Letter 53186 77. Suven Life Sciences Ltd 36063, Approval Letter 53183 78. Tevapharm India Pvt. Ltd 36149, Approval Letter 53219 79. Tevapharm India Pvt. Ltd 36150, Approval Letter 53212 80. Tevapharm India Pvt. Ltd 36151, Approval Letter 53213 81. Tevapharm India Pvt. Ltd 36152, Approval Letter 53218 82. Tevapharm India Pvt. Ltd 36153, Approval Letter 53216 83. Tevapharm India Pvt. Ltd 36154, Approval Letter 53210 84. Tevapharm India Pvt. Ltd 36155, Approval Letter 53207 85. Tevapharm India Pvt. Ltd 36156, Approval Letter 53205 86. Tevapharm India Pvt. Ltd 36157, Approval Letter 53202 87. Torrent Pharmaceuticals Ltd 35908, Approval Letter 52937 88. Torrent Pharmaceuticals Ltd 35911, Approval Letter 52941 89. Torrent Pharmaceuticals Ltd 35912, Approval Letter 52943 90. Torrent Pharmaceuticals Ltd 35909, Approval Letter 52825 91. Torrent Pharmaceuticals Ltd 35910, Approval Letter 52823 92. Umedica Laboratories Pvt Ltd 36058, Approval Letter 53380 93. Unichem Laboratories Ltd 35966, Approval Letter 52910 94. Unique Pharmaceutical 36019, Approval Letter Laboratories 53313 95. Unique Pharmaceutical 36020, Approval Letter Laboratories 53317 96. VerGo Pharma Research 35865, Approval Letter Laboratories Pvt Ltd 52835 97. VerGo Pharma Research 35866, Approval Letter Laboratories Pvt Ltd 52834 98. VerGo Pharma Research 35867, Approval Letter Laboratories Pvt Ltd 52833 99. VerGo Pharma Research 35868, Approval Letter Laboratories Pvt Ltd 52832 100. VerGo Pharma Research 35869, Approval Letter Laboratories Pvt Ltd 52829 101. VerGo Pharma Research 35863, Approval Letter Laboratories Pvt Ltd 52858 102. VerGo Pharma Research 35864, Approval Letter Laboratories Pvt Ltd 52836 103. Vivimed Labs (Alathur) Pvt Ltd 35997, Approval Letter 53283 104. Wockhardt Ltd 35844, Approval Letter 52867

Global Clinical Trial

Sr. No. Name of Firm Reference No. Type of Letter

1. M/s. Eli Lilly 19589 CT NOC Approval Letter

2. M/s. Max Neeman 14842 CT NOC Approval Letter 3. M/s. PRA 21902/33683 Amendment in CT NOC

4. M/s. BMS 14554 PA Letter

COSMETICS DIVISION

S.N COMPANY NAME DIARY NO STATUS O.

1. M/s. JK International , Delhi 32447 Deficiency Letter

2. M/s. Makoha General Trading company Pvt. Ltd, 23256 Deficiency Letter Coimbatore

3. M/s. Valin Cosmetics Pvt. Ltd, Mumbai 32047 Approval Letter

4. M/s. Johnson & Johnson, Mumbai 28132, Approval Letter 28750, 32092

5. M/s. Glosel India Impex Pvt. Ltd, Chennai 29362, Approval Letter 30783