Letters for Issue On20.06.2014

Letters for Issue On20.06.2014

<p> LETTERS FOR ISSUE ON 20.06.2014 GLOBAL CLINICAL TRIAL</p><p>Sr. Name of Firm Reference No. Type of Letter No.</p><p>1. M/s. Biogen Idec - NDAC Follow-up letter</p><p>2. M/s. Novartis 13384/17840 Change in PI Approval</p><p>3. M/s. Chiltern 21481 Amendment in CT NOC Approval</p><p>4. M/s. Novotech 20154 Export NOC Approval</p><p>5. M/s. Quintiles 51053 PA Approval</p><p>6. M/s. Pfizer NDAC Follow-up letter</p><p>7. M/s. Maya Clinicals 23216 Clarification letter</p><p>8. M/s. ICON 54899 Clarification 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) 17441 Approval Letter Pvt. Ltd., Navi Mumbai-400 709</p><p>2. M/s. Agila Specialties Pvt. Ltd., 19862 Clarification Bangaluru-560 076 Letter</p><p>3. M/s. Cliantha Research Limited, 18867 Approval Letter Ahmedabad-380 054</p><p>4. M/s. Famy Care Ltd., Mumbai-400 001 20761 Clarification Letter</p><p>5. M/s. Glenmark Generics Ltd., Navi 19534 Approval Letter Mumbai-400 705 6. M/s. Glenmark Generics Ltd., Navi 19533 Approval Letter Mumbai-400 705</p><p>7. M/s. Inventia Healthcare Pvt. Ltd., Dist. 19527 Approval Letter Thane-421 506</p><p>8. M/s. Lambda Therapeutic Research Ltd., 12351 Additional Study Ahmedabad-380 061 Centre</p><p>9. M/s. Lotus Labs Pvt. Ltd., Chennai-600 21229 Approval Letter 004</p><p>10. M/s. Micro Therapeutic Research Labs 13023 Amendment Pvt. Ltd., Coimbatore-641029 Letter</p><p>11. M/s. Quest Life Sciences (P) Ltd., 20862 Approval Letter Chennai-600045</p><p>12. M/s. Semler Research Center Pvt. Ltd., 14953 Clarification Bangalore-560078 Letter</p><p>13. M/s. Sun Pharmaceutical Industries Ltd., 16636 Clarification Vadodara-390 020 Letter</p><p>14. M/s. Sun Pharmaceutical Industries Ltd., 19014 Approval Letter Vadodara-390 020</p><p>15. M/s. Sun Pharmaceutical Industries Ltd., 19019 Approval Letter Vadodara-390 020</p><p>16. M/s. Synchron Research Services Pvt. 18516 Amendment Ltd., Ahmedabad-380 054 Letter</p><p>17. M/s. Unichem Laboratories Ltd., Mumbai- 48911 Approval Letter 400 102</p><p>18. M/s. Veeda Clinical Research Pvt. Ltd., 22325 Approval Letter Ahmedabad-380 015</p><p>19. M/s. Vimta Labs Ltd., Hyderabad-500051 20234 Approval Letter</p><p>20. M/s. Watson Pharma Pvt. Ltd., Navi 19460 Clarification Mumbai-400 614 Letter</p><p>21. M/s. Wockhardt Limited, Aurangabad- 60283 Approval Letter 431 006 ONLY TEST LICENCE FOR BE</p><p>S. NO. NAME OF THE COMPANY REF. NO. Type of letter</p><p>1. M/s. Accutest Research Laboratories (I) Pvt. 19819 Test Licence Ltd., Navi Mumbai-400 709</p><p>2. M/s. Cliantha Research Limited, Ahmedabad- 18868 Test Licence 380 054</p><p>3. M/s. Cliantha Research Limited, Ahmedabad- 17711 Test Licence 380 054</p><p>4. M/s. Emcure Pharmaceuticals Limited, Pune- 20255 Test Licence 411 026</p><p>5. M/s. GVK Biosciences Pvt. Ltd., Hyderabad-500 23030 Test Licence 038</p><p>6. M/s. Kusum Healthcare Pvt. Ltd., New Delhi- 25433 Test Licence 110 020</p><p>7. M/s. Lambda Therapeutic Research Ltd., 13699 Test Licence Ahmedabad-380 061</p><p>8. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 034 20640 Test Licence</p><p>9. M/s. Om Sai Clinical Research Pvt. Ltd., Sangli- 24884 Test Licence 416 416, Maharsahtra</p><p>10. M/s. Vimta Labs Ltd., Hyderabad-500051 19955 Test Licence</p><p>11. M/s. Watson Pharma Private Ltd., Navi 18446 Test Licence Mumbai-400 614</p><p>12. M/s. Watson Pharma Pvt Ltd ., Navi Mumbai- 19949 Test Licence 400614</p><p>GLOBAL CLINICAL TRIAL</p><p>Sr. Name of Firm Reference No. Type of Letter No. 1. M/s. Biogen Idec 7521/17358 Clarification Letter</p><p>2. M/s. Quintiles 4604 Clarification Letter</p><p>MEDICAL DEVICE</p><p>S.NO. COMPANY NAME DIARY NO STATUS</p><p>1. M/s. Nutri Synapzz Therapeutix Private Limited. 20628 Clarification Letter</p><p>2. M/s. White Pharmaceuticals. 20861 Clarification Letter</p><p>3. M/s. Mais India Medical Devices Pvt. Ltd. 16022 Query Letter (CLAA)</p><p>The State Drugs Controller, Haryana (CLAA)</p><p>TEST LICENCES </p><p>S. No. Name of the Company Diary No. Type of Letter</p><p>1. Actavis Pharma Development 21465, Approval Letter Centre Pvt. Ltd 32013</p><p>2. Actavis Pharma Development 21466, Approval Letter Centre Pvt. Ltd 32018</p><p>3. Actavis Pharma Development 21467, Approval Letter Centre Pvt. Ltd 32023</p><p>4. Alembic Pharmaceuticals Ltd 21521, Approval Letter 31933</p><p>5. APL Research Centre 21336, Approval Letter 31773</p><p>6. Cipla Ltd 21657, Approval Letter 32286</p><p>7. Cipla Ltd 21658, Approval Letter 32282</p><p>8. Cipla Ltd 21659, Approval Letter 32285</p><p>9. Cipla Ltd 21660, Approval Letter 32279</p><p>10. Cipla Ltd 21661, Approval Letter 32277</p><p>11. Cipla Ltd 21662, Approval Letter 32328</p><p>12. Fresenius Kabi Oncology Ltd 16262, Approval Letter 24265, 23360, 34885</p><p>13. Getz Pharma Research Pvt. Ltd 21582, Approval Letter 32264</p><p>14. Getz Pharma Research Pvt. Ltd 21583, Approval Letter 32266</p><p>15. Getz Pharma Research Pvt. Ltd 21584, Approval Letter 32213</p><p>16. Getz Pharma Research Pvt. Ltd 21585, Approval Letter 32217</p><p>17. Getz Pharma Research Pvt. Ltd 21587, Approval Letter 32258</p><p>18. Glenmark Pharmaceuticals Ltd 21533, Approval Letter 31959</p><p>19. Glenmark Pharmaceuticals Ltd 21534, Approval Letter 31965</p><p>20. Glenmark Pharmaceuticals Ltd 21535, Approval Letter 31970</p><p>21. Glenmark Pharmaceuticals Ltd 21536, Approval Letter 31973 22.</p><p>23. Intas Pharmaceuticals Ltd 21593, Approval Letter 32273</p><p>24. Intas Pharmaceuticals Ltd 21594, Approval Letter 32272</p><p>25. Ipca Laboratories Limited 21471, Approval Letter 32040</p><p>26. Ipca Laboratories Limited 21487, Approval Letter 31900</p><p>27. Ipca Laboratories Limited 21488, Approval Letter 31905</p><p>28. Ipca Laboratories Limited 21489, Approval Letter 31909</p><p>29. Ipca Laboratories Limited 21490, Approval Letter 31916</p><p>30. Ipca Laboratories Limited 21491, Approval Letter 31920</p><p>31. Ipca Laboratories Limited 21492, Approval Letter 31927</p><p>32. Lupin Ltd 16110, Approval Letter 24119, 24096, 35600</p><p>33. Mylan Laboratories Ltd 21572, Approval Letter 32227</p><p>34. Novartis Healthcare Pvt Ltd 8644, Approval Letter 13075, 20373, 30575, 22872, 33751</p><p>35. Novartis Healthcare Pvt Ltd 13708, Approval Letter 21391, 22873, 33932</p><p>36. Novartis Healthcare Pvt Ltd 13676, Approval Letter 21166, 22873, 33932</p><p>37. Novartis Healthcare Pvt Ltd 13709, Approval Letter 21388, 22873, 33932</p><p>38. Novartis Healthcare Pvt Ltd 13679, Approval Letter 21170, 22873, 33932</p><p>39. Pfizer Products India Pct Ltd 9647, Approval Letter 14980, 15209, 22959</p><p>40. Pfizer Products India Pct Ltd 9648, Approval Letter 14956, 15210, 22955</p><p>41. RA Chem Pharma Ltd 12404, Approval Letter 19243, 20243</p><p>42. Ranbaxy Laboratories Ltd 21612, Approval Letter 32289</p><p>43. Ranbaxy Laboratories Ltd 12329, Approval Letter 18670, 22317, 33307</p><p>44. Reliance Life Sciences Pvt Ltd 16079, Approval Letter 24173, 20334, 36488</p><p>45. Roche Products (India) Pvt Ltd 17055, Approval Letter 25172, 19878, 29791, 24620, 36015</p><p>46. Sequent Research Ltd 21422, Approval Letter 32059</p><p>47. Sequent Research Ltd 21423, Approval Letter 32069</p><p>48. Shalina Laboratories Pvt Ltd 21524, Approval Letter 31943</p><p>49. Shalina Laboratories Pvt Ltd 21525, Approval Letter 31950</p><p>50. Shasun Pharmaceuticals 21573, Approval Letter Limited 32237</p><p>51. Shasun Pharmaceuticals 21574, Approval Letter Limited 32249</p><p>52. Stabicon Life Sciences Pvt Ltd 21233, Approval Letter 31858</p><p>53. Stabicon Life Sciences Pvt Ltd 21234, Approval Letter 31860</p><p>54. Sun Pharma Advanced 21591, Approval Letter Research Company Ltd 32274</p><p>55. Sun Pharmaceutical Industries 21589, Approval Letter Ltd 32255</p><p>56. Unichem Laboratories Ltd 21486, Approval Letter 32034</p><p>57. United States Pharmacopeia- 21436, Approval Letter India (P) Ltd 32120 58. United States Pharmacopeia- 21437, Approval Letter India (P) Ltd 32118</p><p>59. United States Pharmacopeia- 21438, Approval Letter India (P) Ltd 32117</p><p>60. United States Pharmacopeia- 21439, Approval Letter India (P) Ltd 32116</p><p>61. United States Pharmacopeia- 21459, Approval Letter India (P) Ltd 32112</p><p>62. United States Pharmacopeia- 21460, Approval Letter India (P) Ltd 32107</p><p>63. United States Pharmacopeia- 21461, Approval Letter India (P) Ltd 32121</p><p>64. V-ensure Pharma Technologies 21609, Approval Letter Pvt. Ltd 32268</p><p>65. Watson Pharma Pvt. Ltd 21470, Approval Letter 32028</p><p>66. Wintac Ltd 14436, Approval Letter 21919, 21419, 32063</p><p>67. APL Research Centre 18703, Deficiency 27933 Letter</p><p>68. Cipla Ltd 20060, Deficiency 30326 Letter</p><p>69. Getz Pharma Research Pvt Ltd 21318, Deficiency 31582 Letter</p><p>70. Ipca Laboratories Ltd 20623, Deficiency 30732, Letter 20626, 30889, 20627, 30886 71. Jubilant Life Sciences Ltd 20827, Deficiency 31034 Letter</p><p>72. Modi Mundipharma Pvt Ltd 21424, Deficiency 32122 Letter</p><p>73. RA Chem Pharma Ltd 20242, Deficiency 30102 Letter</p><p>74. Sanofi-Synthelabo (India) Ltd 20709, Deficiency 31031, Letter 20710, 31027, 20712, 30966, 20713, 30962, 20714, 30654, 20716, 30657, 20930, 31168, 20942, 31181, 20943, 31308, 20944, 31306</p><p>75. Shilpa Medicare Ltd 17182, Deficiency 25478 Letter</p><p>76. Stabicon Life Sciences Pvt Ltd 21235, Deficiency 31862, Letter 21238, 31732, 21238-A, 31729, </p><p>77. Stabicon Life Sciences Pvt Ltd 21095, Deficiency 31723 Letter</p><p>78. Vimta Labs Ltd 20986, Deficiency 31082 Letter</p>

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