Letters for Issue on 07.04.2014

Letters for Issue on 07.04.2014

<p> LETTERS FOR ISSUE ON 07.04.2014 COSMETIC DIVISION </p><p>S.N COMPANY NAME DIARY NO STATUS O.</p><p>1. M/s. L’Oreal Iindia Pvt. Ltd, Mumbai 60124,62410,8826 Approval Letter</p><p>2. M/s. Stiefel India (Private) Limited, 7634 Approval Letter Mumbai</p><p>3. M/s. International Flavours & FTS NO. 74683 Deficiency Fragrances India Private Limited, Letter Chennai</p><p>4. M/s. Avalon Cosmetics Pvt. Ltd, 3352 Application Himachal Pradesh withdrawn</p><p>5. M/s. Baccarose Perfumes & Beauty 7529 Deficiency Products Pvt. Ltd, Mumbai Letter</p><p>BE NOC FOR EXPORT</p><p>S. NO. NAME OF THE COMPANY REF. NO. Type of letter</p><p>1. M/s. Accutest Research Laboratories (I) 4292 Amendment Pvt. Ltd., Navi Mumbai-400 709 Letter</p><p>2. M/s. Accutest Research Laboratories (I) 3070 Amendment Pvt. Ltd., Navi Mumbai-400 709 Letter</p><p>3. M/s. Accutest Research Laboratories (I) 6928 Approval Letter Pvt. Ltd., Navi Mumbai-400 709</p><p>4. M/s. Accutest Research Laboratories (I) 8247 Approval Letter Pvt. Ltd., Navi Mumbai-400 709</p><p>5. M/s. Actimus Biosciences Pvt. Ltd., 3875 Approval Letter Visakhapatnam-530 003 6. M/s. Aizant Drug Research Solutions Pvt. 6549 Approval Letter Ltd., Hyderabad-500 010</p><p>7. M/s. Alembic Pharmaceuticals Ltd., 14136 Amendment Vadodara-390 003 Letter</p><p>8. M/s. Apotex Research Pvt. Ltd., 3917 Clarification Bangalore-560 099 Letter</p><p>9. M/s. Apotex Research Pvt. Ltd., 2995 Amendment Bangalore-560 099 Letter</p><p>10. M/s. Axis Clinicals Ltd., Hyderabad-500 825 Clarification 049 Letter</p><p>11. M/s. Azidus Laboratories Ltd., Chennai- 31901 Approval Letter 600 048</p><p>12. M/s. Cliantha Research Limited, 6222 Approval Letter Ahmedabad-380 054</p><p>13. M/s. Cliantha Research Limited, 5005 Approval Letter Ahmedabad-380 054</p><p>14. M/s. Dr. Reddy’s Laboratories Ltd., 2216 Clarification Hyderabad-500 016 Letter</p><p>15. M/s. Drug Monitoring Research Institute 10217 Approval Letter (P) Ltd., Navi Mumbai-400 701</p><p>16. M/s. Emcure Pharmaceuticals Limited, 2133 Amendment Pune-411 026 Letter</p><p>17. M/s. Emcure Pharmaceuticals Limited, 3557 Approval Letter Pune-411 026</p><p>18. M/s. GVK Biosciences Pvt. Ltd., 3426 Amendment Ahmedabad-380 051 Letter</p><p>19. M/s. Jubilant Life Sciences Limited, 3635 Approval Letter Noida-201 307, UP</p><p>20. M/s. Lambda Therapeutic Research Ltd., 1282 Clarification Ahmedabad-380 061 Letter</p><p>21. M/s. Lambda Therapeutic Research Ltd., 3311 Amendment Ahmedabad-380 061 Letter</p><p>22. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 2146 Amendment 052 Letter</p><p>23. M/s. Lupin Bioresearch Center, Pune-411 3876 Approval Letter 021</p><p>24. M/s. Manipal AcuNova Limited, Manipal 6227 Approval Letter -576 104</p><p>25. M/s. Manipal Acunova Ltd., Mangalore- 1037 Amendment 575 001 Letter</p><p>26. M/s. Norwich Clinical Services Pvt Ltd, 6702 Approval Letter Bangalore-560034</p><p>27. M/s. Ranbaxy Laboratories Ltd., Gurgaon- 11929 Amendment 122 015 Letter</p><p>28. M/s. Ranbaxy Laboratories Ltd., New 6813 Approval Letter Delhi-110 019</p><p>29. M/s. Reliance Life Sciences Pvt. Ltd., Navi 49953 Rejection Letter Mumbai-400 701</p><p>30. M/s. Reliance Life Sciences Pvt. Ltd., Navi 62687 Approval Letter Mumbai-400 701</p><p>31. M/s. Reliance Life Sciences Pvt. Ltd., Navi 11115 Approval Letter Mumbai-400 701</p><p>32. M/s. Synchron Research Services Pvt. 6460 Approval Letter Ltd., Ahmedabad-380 054</p><p>33. M/s. Themis Medicare Ltd., Mumbai-400 64709 Rejection Letter 104</p><p>34. M/s. Themis Medicare Ltd., Mumbai-400 64708 Rejection Letter 104</p><p>35. M/s. Torrent Pharmaceuticals Ltd. 712 Amendment (Research Centre), Gujarat Letter</p><p>36. M/s. Torrent Pharmaceuticals Ltd. 52383 Amendment (Research Centre), Gujarat Letter 37. M/s. Veeda Clinical Research Pvt. Ltd., 8739 Approval Letter Ahmedabad-380 015</p><p>38. M/s. Veeda Clinical Research Pvt. Ltd., 6637 Approval Letter Ahmedabad-380 015</p><p>39. M/s. Veeda Clinical Research Pvt. Ltd., 8740 Approval Letter Ahmedabad-380 015</p><p>40. M/s. Veeda Clinical Research Pvt. Ltd., 6590 Approval Letter Ahmedabad-380 015</p><p>41. M/s. Veeda Clinical Research Pvt. Ltd., 5771 Approval Letter Ahmedabad-380 015</p><p>42. M/s. Vimta Labs Ltd., Hyderabad-500 051 4611 Clarification Letter</p><p>43. M/s. Watson Pharma Pvt. Ltd., Navi 1021 Clarification Mumbai-400 614 Letter</p><p>44. M/s. Wockhardt Limited - CPB, 3521 Amendment Aurangabad-431 210 Letter</p><p>ONLY TEST LICENCE FOR BE</p><p>S. NO. NAME OF THE COMPANY REF. NO. Type of letter</p><p>1. M/s. Aizant Drug Research Solutions Pvt. 6548 Test Licence Ltd., Hyderabad-500 010</p><p>2. M/s. Emcure Pharmaceuticals Limited, 3363 Test Licence Pune-411 026</p><p>3. M/s. Kusum Healthcare Pvt. Ltd., New 3420 Test Licence Delhi-110 020</p><p>4. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 2255 Test Licence 052</p><p>5. M/s. Ranbaxy Laboratories Ltd., 4201 Test Licence Gurgaon-122 015</p><p>6. M/s. Ranbaxy Laboratories Ltd., 54279 Test Licence Gurgaon-122 015</p><p>7. M/s. Ranbaxy Laboratories Ltd., 54276 Test Licence Gurgaon-122 015</p><p>8. M/s. Ranbaxy Laboratories Ltd., 54277 Test Licence Gurgaon-122 015</p><p>9. M/s. Ranbaxy Laboratories Ltd., 54278 Test Licence Gurgaon-122 015</p><p>10. M/s. Ranbaxy Laboratories Ltd., 7822 Test Licence Gurgaon-122 015</p><p>11. M/s. Ranbaxy Laboratories Ltd., 8252 Test Licence Gurgaon-122 015</p><p>12. M/s. Reliance Life Sciences Pvt. Ltd., 12860 Test Licence Navi Mumbai-400 701</p><p>13. M/s. Veeda Clinical Research Pvt. Ltd., 7865 Test Licence Ahmedabad-380 015</p><p>SUBSEQUENT NEW DRUG S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO.</p><p>1. M/s Intas 34364 - Approval Letter Pharmaceuticals (2)</p><p>2. M/s MSN Lab Ltd. 52168 - Approval Letter </p><p>3. M/s Glaxo Smithkline 32453 Approval Letter </p><p>4. M/s Akums Drugs 63648 87805 Deficiency Letter</p><p>VACCINE DIVISION</p><p>S. No. COMPANY NAME Dy.No. STATUS 1 M/s Kasiak Research Pvt Ltd 28015 Approval letter</p><p>2 M/s Lupin Limited 7379 Permission Letter</p><p>3 M/s Globion India Pvt Ltd 8204 Approval letter</p><p>4 M/s Panacea Biotec Ltd 56138 Approval letter & clarification letter</p><p>5 M/s Sanofi Synthelabo (India) 2456 Permission Letter Ltd</p><p>6 M/s LG Life Sciences India Pvt 11381 Clarification letter Ltd</p><p>7 M/s Jhonson & Jhonson Ltd 9691 Clarification letter</p><p>8 M/s Shantha Biotechnics 60841 Clarification letter Limited</p><p>9 M/s Human Biological Clarification letter Institute</p><p>10 M/s Bharat Biotech Clarification letter International Ltd</p><p>11 M/s Wockhardt Ltd Clarification letter</p><p>12 M/s Stallen South Asia Pvt, 36443 Approval letter Ltd </p><p>13 M/s Intervet India Pvt, Ltd 7937 Approval letter</p><p>14 M/s Cadila Pharmaceuticals 9013 (fts no) Approval letter Ltd</p><p>BIOLOGICAL DIVISION</p><p>S. No. COMPANY NAME Dy.No. STATUS 1 M/s Indian Immunologicals 4141 Approval letter Limited</p><p>FDC DIVISION</p><p>S.NO. NAME OF COMPANY DIARY DOCUMENT NO 1. M/s. Ajanta Pharma Ltd., 9591 Letter</p><p>TEST LICENCES</p><p>S. No. Name of the Company Diary No. Type of Letter</p><p>1. Abbott Healthcare Pvt Ltd 8615, Approval Letter 13056</p><p>2. Actavis Pharma Development 8805, Approval Letter Centre Pvt Ltd 13412</p><p>3. Agila Specialties Pvt Ltd 4913, 7510 Approval Letter</p><p>4. Agila Specialties Pvt. Ltd 8966, Approval Letter 13821</p><p>5. Agila Specialties Pvt. Ltd 8974, Approval Letter 13825</p><p>6. Agila Specialties Pvt. Ltd 8973, Approval Letter 13828</p><p>7. Alembic Pharmaceuticals Ltd 8955, Approval Letter 13805</p><p>8. Alembic Pharmaceuticals Ltd 8954, Approval Letter 13800</p><p>9. Alembic Pharmaceuticals Ltd 8953, Approval Letter 13793</p><p>10. Alembic Pharmaceuticals Ltd 8959, Approval Letter 13815 11. Alembic Pharmaceuticals Ltd 8958, Approval Letter 13814</p><p>12. Alembic Pharmaceuticals Ltd 8957, Approval Letter 13811</p><p>13. Alembic Pharmaceuticals Ltd 8956, Approval Letter 13809</p><p>14. Alembic Pharmaceuticals Ltd 8960, Approval Letter 13817</p><p>15. Alembic Pharmaceuticals Ltd 8965, Approval Letter 13819</p><p>16. Alkem Laboratories Ltd 8592, Approval Letter 13111</p><p>17. Alphamed Formulations Pvt. 8688, Approval Letter Ltd. 13514</p><p>18. APL Research Centre 8624, Approval Letter 13059</p><p>19. APL Research Centre 8629, Approval Letter 13083</p><p>20. APL Research Centre 8628, Approval Letter 13086</p><p>21. APL Research Centre 8627, Approval Letter 13088</p><p>22. APL Research Centre 8626, Approval Letter 13092</p><p>23. APL Research Centre 8625,1309 Approval Letter 5</p><p>24. Apotex Research Pvt Ltd 8867, Approval Letter 13876</p><p>25. Biogen Idec Biotech India Pvt 9013, Approval Letter Ltd 13852</p><p>26. Cadila Healthcare Ltd 9030, Approval Letter 13875</p><p>27. Cadila Healthcare Ltd 9029, Approval Letter 13874</p><p>28. Cadila Healthcare Ltd 9020, Approval Letter 13861</p><p>29. Cadila Healthcare Ltd 9021, Approval Letter 13863</p><p>30. Cadila Healthcare Ltd 9022, Approval Letter 13865</p><p>31. Cadila Healthcare Ltd 9026, Approval Letter 13866</p><p>32. Cipla Ltd 8801, Approval Letter 13338</p><p>33. Cipla Ltd 8800, Approval Letter 13341</p><p>34. Cipla Ltd 8798, Approval Letter 13342</p><p>35. Cipla Ltd 8799, Approval Letter 13345</p><p>36. Cipla Ltd 8797, Approval Letter 13349</p><p>37. Cipla Ltd 8796, Approval Letter 13351</p><p>38. Cipla Ltd 8795, Approval Letter 13353</p><p>39. Cipla Ltd 8794, Approval Letter 13355</p><p>40. Claris LifeSciences Ltd 8875, Approval Letter 13878</p><p>41. Dr. Reddy’s Laboratories Ltd 8549, Approval Letter 13020 42. Dr. Reddy’s Laboratories Ltd 8550, Approval Letter 13013</p><p>43. Dr. Reddy’s Laboratories Ltd 8548, Approval Letter 13031</p><p>44. Famy Care Ltd 9016, Approval Letter 13857</p><p>45. Famy Care Ltd 2039, Approval Letter 13746</p><p>46. Getz Pharma Research Pvt Ltd 8902, Approval Letter 13880</p><p>47. Gland Pharma Ltd 3742, Approval Letter 5758, 11933, 18058</p><p>48. Glenmark Generics Ltd 8821, Approval Letter 13419</p><p>49. Glenmark Generics Ltd 8829, Approval Letter 13419</p><p>50. Glenmark Generics Ltd 9025, Approval Letter 13867</p><p>51. Glenmark Pharmaceuticals Ltd 8822, Approval Letter 13417</p><p>52. Hospira Healthcare India Pvt. 8583, Approval Letter Ltd. 13128</p><p>53. Hospira Healthcare India Pvt. 8584, Approval Letter Ltd. 13125</p><p>54. Hospira Healthcare India Pvt. 8585, Approval Letter Ltd. 13118</p><p>55. Hospira Healthcare India Pvt. 8586, Approval Letter Ltd. 13112</p><p>56. Indeus Life Sciences Pvt. Ltd 8538, Approval Letter 13018 57. Indeus Life Sciences Pvt. Ltd. 8539, Approval Letter 13015</p><p>58. Ipca Laboratories Limited 8694, Approval Letter 13466</p><p>59. Ipca Laboratories Limited 8695, Approval Letter 13501</p><p>60. Ipca Laboratories Limited 8696, Approval Letter 13498</p><p>61. Ipca Laboratories Limited 8698, Approval Letter 13496</p><p>62. Johnson and Johnson Ltd 8693, Approval Letter 13472</p><p>63. Johnson and Johnson Ltd 8733, Approval Letter 13439</p><p>64. Jubilant Life Sciences Ltd 8850, Approval Letter 13475</p><p>65. Lupin Ltd 8756, Approval Letter 13451</p><p>66. Mylan Laboratories Ltd 8736, Approval Letter 13444</p><p>67. Mylan Laboratories Ltd 8757, Approval Letter 13465</p><p>68. Mylan Laboratories Ltd 8758, Approval Letter 13402</p><p>69. Mylan Laboratories Ltd 8734, Approval Letter 13431</p><p>70. National Institute of Mental 562, 17512 Approval Letter Health & Neuro Sciences</p><p>71. National Institute of Mental 560, 17512 Approval Letter Health & Neuro Sciences 72. National Institute of Mental 556, 17512 Approval Letter Health & Neuro Sciences</p><p>73. National Institute of Mental 557, 17512 Approval Letter Health & Neuro Sciences</p><p>74. Nektar Therapeutics India Pvt 8595, Approval Letter Ltd 13044</p><p>75. Nektar Therapeutics India Pvt 8596, Approval Letter Ltd 13046</p><p>76. Novartis Healthcare Pvt Ltd 8650, Approval Letter 13065</p><p>77. Novartis Healthcare Pvt Ltd 8647, Approval Letter 13067</p><p>78. Novartis Healthcare Pvt Ltd 8646, Approval Letter 13069</p><p>79. Novartis Healthcare Pvt Ltd 8645, Approval Letter 13071</p><p>80. Novartis Healthcare Pvt Ltd 8643, Approval Letter 13079</p><p>81. Novartis Healthcare Pvt Ltd 8648, Approval Letter 13099</p><p>82. Novartis Healthcare Pvt Ltd 8649, Approval Letter 13101</p><p>83. Par Formulations Pvt Ltd 8658, Approval Letter 13037</p><p>84. Perrigo Laboratories India Pvt 8996, Approval Letter Ltd 13832</p><p>85. Perrigo Laboratories India Pvt 8997, Approval Letter Ltd 13836</p><p>86. Perrigo Laboratories India Pvt 8998, Approval Letter Ltd 13838 87. Perrigo Laboratories India Pvt 9001, Approval Letter Ltd 13840</p><p>88. Piramal Enterprises Ltd 8945, Approval Letter 13791</p><p>89. Piramal Enterprises Ltd 8944, Approval Letter 13788</p><p>90. Sanofi-Synthelabo (India) Ltd. 8972, Approval Letter 13824</p><p>91. Sanofi-Synthelabo (India) Ltd. 8971, Approval Letter 13822</p><p>92. Sentiss Pharma Ltd 3390, Approval Letter 5459, 8869, 13882</p><p>93. Sidmak Laboratories Ltd 2944, Approval Letter 4839, 9988, 15324, </p><p>94. Tevapharm India Pvt Ltd 8793, Approval Letter 13359</p><p>95. Tevapharm India Pvt Ltd 8792, Approval Letter 13395</p><p>96. USV Ltd 9009, Approval Letter 13844</p><p>97. USV Ltd 9011, Approval Letter 13847</p><p>98. Vimta Labs Ltd 8738, Approval Letter 13455</p><p>99. Vimta Labs Ltd 8737, Approval Letter 13462</p><p>100. Vimta Labs Ltd 8732, Approval Letter 13435 101. Watson Pharma Pvt. Ltd 8724, Approval Letter 13510</p><p>102. Watson Pharma Pvt. Ltd 8723, Approval Letter 13506</p><p>103. Wockhardt Ltd 65116, Approval Letter 89225</p><p>104. Wockhardt Ltd 8935, Approval Letter 13749</p><p>105. Wockhardt Ltd 8934, Approval Letter 13742</p><p>NEW DRUG</p><p>S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. M/s. Y.R. Gaitonde Medical - Approval Letter (2) Education and Research Foundation 2. M/s. Intas Pharmaceuticals - Clarification Letter</p>

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