<p> LETTERS FOR ISSUE ON 06.06.2014 GLOBAL CLINICAL TRIAL</p><p>Sr. No. Name of Firm Reference No. Type of Letter 1. M/s. J&J 54739/59052 Clarification letter 2. M/s. Parexel 2671 Clarification Letter 3. M/s. PPD - 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. APL Research Centre, Hyderabad- 56941 Approval Letter 500 090</p><p>2. M/s. Azidus Laboratories Ltd., Chennai- 17446 Clarification 600 048 Letter</p><p>3. M/s. Cipla Ltd., Mumbai-400 008 14565 Rejection Letter</p><p>4. M/s. Cliantha Research Limited, 22053 Approval Letter Ahmedabad-380 054</p><p>5. M/s. Clinigene International Ltd., 17431 Approval Letter Bangalore-560 100</p><p>6. M/s. Lambda Therapeutic Research Ltd., 18199 Approval Letter Ahmedabad-380 061</p><p>7. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 16547 Approval Letter 052</p><p>8. M/s. Lupin Bioresearch Center, Pune-411 17212 Clarification 021 Letter</p><p>9. M/s. Lupin Bioresearch Center, Pune-411 18240 Approval Letter 021 10. M/s. Manipal AcuNova KMC Clinical 15303 Approval Letter Pharmacology Unit, Mangalore-575 001</p><p>11. M/s. Micro Therapeutic Research Labs 7785 Approval Letter Pvt. Ltd., Chennai-600059</p><p>12. M/s. Micro Therapeutic Research Labs 18168 Approval Letter Pvt. Ltd., Coimbatore-641029 Tamil Nadu</p><p>13. M/s. Psychotropics India Ltd., Haridwar- 15120 Clarification 249 403 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. Accutest Research Laboratories (I) Pvt. 17994 Test Licence Ltd., Navi Mumbai-400 709</p><p>2. M/s. Apotex Research Pvt. Ltd., Bangalore-560 18177 Test Licence 099</p><p>3. M/s. Lambda Therapeutic Research Ltd., 18198 Test Licence Ahmedabad-380 061</p><p>4. M/s. Lotus Labs Pvt. Ltd., Bangalore-560 052 18057 Test Licence</p><p>5. M/s. Lupin Bioresearch Center, Pune-411 021 18149 Test Licence</p><p>6. M/s. Lupin Bioresearch Center, Pune-411 021 18148 Test Licence</p><p>7. M/s. Semler Research Center Pvt. Ltd., 18207 Test Licence Bangalore-560078</p><p>8. M/s. Strides Arcolab Ltd., Bangalore -560076 16669 Test Licence</p><p>9. M/s. Watson Pharma Pvt. Ltd., Navi Mumbai- 17434 Test Licence 400 614</p><p>MEDICAL DEVICE</p><p>S.NO. COMPANY NAME DIARY NO STATUS 1. M/s. Biotech Vision Care Pvt. Ltd. 17192 Query Letter</p><p>2. M/s. Baxter (India) Pvt. Ltd. 14298 Query Letter</p><p>3. M/s. B. L. Life Sciences Pvt. Ltd. 15108 Query Letter</p><p>4. M/s. Covidien Healthcare India Pvt. Ltd. 19625 Query Letter</p><p>5. M/s. Depuy Medical Pvt. Ltd. 16590 Query Letter</p><p>6. M/s. Johnson & Johnson Ltd. 1650 Query Letter</p><p>7. M/s. Manju Enterprise Pvt. Ltd. 16403 Query Letter</p><p>8. M/s. St. Jude Medical Pvt. Ltd. 11825 Query Letter</p><p>9. M/s. Biorad Medisys Pvt. Ltd. (CLAA) 8060 Query Letter</p><p>DIAGNOSTIC DIVISION</p><p>S.NO. COMPANY NAME DIARY NO STATUS</p><p>1. M/s. ADI Diagnostics Pvt. Ltd. 17425 Query Letter</p><p>2. M/s. Biogenix Inc. 17146 Query Letter</p><p>3. M/s. Biosystem Diagnostics Pvt. Ltd. 16469 Query Letter</p><p>4. M/s. Piramal Enterprise Ltd. 16908 Query Letter</p><p>5. M/s. Innobreeze Technologies. FTS-20625 Query Letter</p><p>6. Dr. Neeru Singh, Jabalpur FTS-27336 Query Letter</p><p>SUBSEQUENT NEW DRUG</p><p>S. NAME OF THE FIRM REFERENCE FTS NO. TYPE OF LETTER NO. NO.</p><p>1. M/s Intas 32617 45722 Deficiency Letter Pharmaceuticals Ltd. </p><p>TEST LICENCES S. No. Name of the Company Diary No. Type of Letter</p><p>1. Alkem Laboratories Ltd 19613,294 Approval Letter 28</p><p>2. Alkem Laboratories Ltd 19614,294 Approval Letter 59</p><p>3. Alkem Laboratories Ltd 19615,294 Approval Letter 60</p><p>4. Alkem Laboratories Ltd 19616,294 Approval Letter 61</p><p>5. Alkem Laboratories Ltd 19617,294 Approval Letter 62</p><p>6. Alphamed Formulations Pvt. 19394, Approval Letter Ltd 29305</p><p>7. Biocon Limited 19747, Approval Letter 29714</p><p>8. Biocon Limited 19748, Approval Letter 29711</p><p>9. Biocon Limited 19749, Approval Letter 29718</p><p>10. Biocon Limited 19750, Approval Letter 29842</p><p>11. Biocon Limited 19751, Approval Letter 29844</p><p>12. Biocon Limited 19752, Approval Letter 29847</p><p>13. Biocon Limited 19753, Approval Letter 29848</p><p>14. Biocon Limited 19754, Approval Letter 29850</p><p>15. Biocon Limited 19755, Approval Letter 29838 16. Biocon Limited 19756, Approval Letter 29834</p><p>17. Biocon Limited 19757, Approval Letter 29830</p><p>18. Biocon Limited 19758, Approval Letter 29829</p><p>19. Biocon Limited 19759, Approval Letter 29828</p><p>20. Biocon Limited 19763, Approval Letter 29825</p><p>21. Biocon Limited 19764. Approval Letter 29822</p><p>22. Cadila Pharmaceutical Limited 19537, Approval Letter 29244</p><p>23. Cadila Pharmaceutical Limited 19538, Approval Letter 29242</p><p>24. Cipla Ltd 19631,293 Approval Letter 21</p><p>25. Cipla Ltd 19632,293 Approval Letter 17</p><p>26. Cipla Ltd 19633,293 Approval Letter 12</p><p>27. Cipla Ltd 19634,293 Approval Letter 08</p><p>28. Cipla Ltd 19635,293 Approval Letter 04</p><p>29. Claris Lifesciences Ltd 19389, Approval Letter 29316</p><p>30. Claris Lifesciences Ltd 19390, Approval Letter 29311</p><p>31. Emcure Pharmaceuticals Ltd 19548, Approval Letter 29391</p><p>32. Evonik India Pvt Ltd 18225, Approval Letter 27726</p><p>33. Getz Pharma Research Pvt. Ltd 19773, Approval Letter 29816</p><p>34. Glenmark Generics Ltd 19514, Approval Letter 29036</p><p>35. Glenmark Generics Ltd 19685, Approval Letter 29267</p><p>36. Glenmark Generics Ltd 19686, Approval Letter 29252</p><p>37. Glenmark Generics Ltd 19687, Approval Letter 29250</p><p>38. Glenmark Generics Ltd 19688, Approval Letter 29249</p><p>39. Hospira Healthcare India Pvt. 19624,294 Approval Letter Ltd 69</p><p>40. Indeus Life Sciences Pvt. Ltd 19524, Approval Letter 29034</p><p>41. Indeus Life Sciences Pvt. Ltd 19525, Approval Letter 29033</p><p>42. Indoco Remedies Ltd 19401, Approval Letter 29287</p><p>43. Indoco Remedies Ltd 19406, Approval Letter 29282</p><p>44. Indoco Remedies Ltd 19407, Approval Letter 29280</p><p>45. Indoco Remedies Ltd 19408, Approval Letter 29336</p><p>46. Inventia Healthcare Pvt. Ltd 19539, Approval Letter 29394 47. Jagsonpal Pharmaceuticals Ltd 19411, Approval Letter 29348</p><p>48. Johnson and Johnson Ltd 19449, Approval Letter 29246</p><p>49. Johnson and Johnson Ltd 19555, Approval Letter 29387</p><p>50. Johnson and Johnson Ltd 17989, Approval Letter 27013</p><p>51. Johnson and Johnson Ltd 17990, Approval Letter 27012</p><p>52. Jubilant Life Sciences Ltd 18507, Approval Letter 27613</p><p>53. Jubilant Life Sciences Ltd 17154, Approval Letter 25562</p><p>54. Lupin Ltd 19429, Approval Letter 29291</p><p>55. Lupin Ltd 19430, Approval Letter 29322</p><p>56. Lupin Ltd 19431, Approval Letter 29274</p><p>57. Lupin Ltd 19432, Approval Letter 29297</p><p>58. Lupin Ltd 19433, Approval Letter 29295</p><p>59. Perrigo Laboratories India Pvt 19630,293 Approval Letter Ltd 47</p><p>60. Piramal Enterprises Ltd 18485, Approval Letter 27612</p><p>61. Ranbaxy Laboratories Ltd 19402, Approval Letter 29330</p><p>62. Ranbaxy Laboratories Ltd 19562, Approval Letter 29346</p><p>63. Ranbaxy Laboratories Ltd 17181, Approval Letter 25499</p><p>64. Ranbaxy Laboratories Ltd 19563, Approval Letter 29343</p><p>65. Ranbaxy Laboratories Ltd 19564,293 Approval Letter 40</p><p>66. Ranbaxy Laboratories Ltd 19565,293 Approval Letter 35</p><p>67. Rubicon Research Pvt. Ltd 19566,294 Approval Letter 00</p><p>68. Rusan Pharma Ltd 18598, Approval Letter 27863</p><p>69. Rusan Pharma Ltd 18597, Approval Letter 27860</p><p>70. Strides Arcolab Ltd 19623,294 Approval Letter 67</p><p>71. Tevapharm India Private 19767, Approval Letter limited 29742</p><p>72. Tevapharm India Private 19768, Approval Letter limited 29750</p><p>73. Torrent Pharmaceuticals Ltd 19601,294 Approval Letter 20</p><p>74. Torrent Pharmaceuticals Ltd 19602,294 Approval Letter 22</p><p>75. Torrent Pharmaceuticals Ltd 19603,294 Approval Letter 25</p><p>76. Unichem Laboratories Ltd 19652, Approval Letter 29328</p><p>77. Unichem Laboratories Ltd. 19649,293 Approval Letter 42 78. Unichem Laboratories Ltd. 19650,293 Approval Letter S. No. COMPANY NAME Dy.No. STATUS 34 1 M/s79. Biovet UnichemPvt, Ltd Laboratories14407, Ltd. 13529 19651,293Approval &Approval Clarification Letter 31 Letter 2 M/s80. AbbottUSV India Limited Ltd 12577 19586,294Approval LetterApproval Letter 13 3 M/s81. Roche USVProduct(india) Limited 13817 19587,294ClarificationApproval Letter Letter Pvt, Ltd 16</p><p>4 M/s82. IntervetVerGo India Pharma Pvt, Ltd Research 7916 19523,Approval LetterApproval Letter Laboratories Pvt Ltd 29035</p><p>VACCINE DIVISION</p>