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Transcription:

S FOR ISSUE ON 15.10.2015 INTERNATIONAL CELL S. NO FIRM NAME TYPE 1 M/S NATCO PHARMA LIMITED HYDERABAD MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. GENETIX BIOTECH ASIA PVT. LTD. 22073 APPROVAL (F-RC) 2. M/S. GENETIX BIOTECH ASIA PVT. LTD. 22073 APPROVAL (F-IL) 3. M/S. BAUSCH & LOMB INDIA PVT. LTD. 23581 4. M/S. ENCARTA PHARMA PVT. LTD. 23339 QUERY 5. M/S. FUSION MEDICAL & DENTAL TECHNOLOGY CO. 11384 QUERY 6. M/S. HALYARD HEALTH INDIA PVT. LTD. 15039 QUERY 7. M/S. HALYARD HEALTH INDIA PVT. LTD. 16488 QUERY 8. M/S. JOHNSON & JOHNSON PVT. LTD. 11843 QUERY 9. M/S. SMITHS MEDICAL INDIA PVT. LTD. 19317 QUERY 10. THE DRUGS LICENSING & CONTROLLING AUTHORITY, LUCKNOW (CLAA), THE DEPUTY DRUGS CONTROLLER (I), GHAZIABAD (CLAA) ( M/S. GPC MEDICAL LTD., GHAZIABAD ) FTS. NO. - 51173 QUERY 11. M/S. CLAIRVOYANCE CONSULTING 30935 12. M/S. SHREYAAS HEALTHCARE 29344 13. M/S. SHREYAAS HEALTHCARE 29343 14. M/S. KENTRON BIOTECHNOLOGY PVT. LTD. 16753

15. M/S. JOHNSON & JOHNSON PVT. LTD. 30051 16. M/S. SANDOR MEDICAIDS PVT. LTD. 26978 DIAGNOSTICS DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. EMERGO (INDIA) CONSULTING PVT. LTD. 20888 QUERY 2. M/S. NUCLEUS INC. 9335 QUERY 3. M/S. SIEMENS LIMITED FTS. NO. - 46086 QUERY 4. M/S. SIEMENS LIMITED NIL FDC DIVISION S.NO. NAME OF COMPANY DIARY NO DOCUMENT 1. M/S. ZUVENTUS HEALTHCARE LTD., 40788 2. M/S. SUN PHARMA LABORATORIES 24452 SITE ADDITION 3. M/S. D.M. PHARMA 18632 4. M/S. RAVENBHEL HEALTHCARE 42022 CLARIFICATION 5. M/S. BLISS GVS PHARMA 42432 6. M/S. FDC LTD., NIL 7. M/S. GLENMARK PHARMACEUTICALS LTD., NIL CLARIFICATION 8. M/S. THEON PHARMACEUTICALS 15554 CLARIFICATION 9. M/S. ZUVENTUS HEALTHCARE LTD., NIL 10. M/S. CENTAUR PHARMACEUTICALS NIL

11. M/S. MEDLEY PHARMACEUTICALS NIL 12. M/S. UNIMED TECHNOLOGIES LTD., 6871/8298 APPROVAL 13. M/S. SUN PHARMA LABORATORIES NIL SEC 14. M/S. THEON PHARMACEUTICALS NIL SEC SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/S INTAS - - SEC PHARMACEUTICALS 2. M/S IPCA - - SEC (3) 3. M/S MYLAN - - SEC 4. M/S NOVARTIS - - SEC 5. M/S KUSUM - - SEC HEALTHCARE 6. M/S INVENTIA - - SEC 7. M/S VIRCHOW - - SEC 8. M/S RUSAN - - SEC 9. M/S CIPLA - - SEC 10. M/S TROIKAA - - SEC (2) 11. M/S AKUMS - - SEC 12. M/S SUN PHARMA - - SEC IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. BIOSYNTH INDIA 32355 APPROVAL 2. PHAROSE REMEDIES LIMITED 32408 APPROVAL 3. MEDI PHARMA DRUG HOUSE 32289 APPROVAL 4. MEDI PHARMA DRUG HOUSE 32290 APPROVAL 5. MEDOPHARM PRIVATE LIMITED 32384 APPROVAL 6. B.M.CHEMIE 32746 APPROVAL 7. PRADIPKUMAR & CO. 32747 APPROVAL 8. PRADIPKUMAR & CO. 32748 APPROVAL 9. HINDUSTAN CHEMICALS & PHARMACEUTICALS 32442 CLARIFICATION

10. EASTERN CHEMICALS (MUMBAI) 32195 CLARIFICATION PVT. LTD. 11. KARNATAKA ANTIBIOTIC & 32163 CLARIFICATION PHARMACEUTICALS LTD. 12. SYMBIO GENERRRICS INDIA PVT. NIL CLARIFICATION LTD 13. MICRO LABS LTD. 32286 CLARIFICATION 14. HARSHADA CORPORATION 32382,32381 02 CLARIFICATION REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. RATNAKAR IMPORTS LLP 28965 APPROVAL 2. ABBOTT INDIA LTD. 30421 AMENDED 3. ALLIED PHARMA SOLUTION 28465 CLARIFICATION 4. BAYER PHARMACEUTICALS PVT. 24944 CLARIFICATION LTD. 5. NOVARTIS HEALTHCARE PVT. LTD. 23263 CLARIFICATION 6. DAEWOONG PHARMACEUTICAL 31728 CLARIFICATION PVT. LTD. 7. MSD PHARMACEUTICALS PVT. LTD. 31668 CLARIFICATION 8. VITUS GLOBAL INC 31954 CLARIFICATION VACCINE DIVISION S. NO. COMPANY NAME DY. NO STATUS 1 M/S FERRING PHARMACEUTICALS PVT, LTD 2 M/S PAVIOUR PHARMACEUTICALS PVT, LTD 24081 CLARIFICATION 25246 CLARIFICATION 3 M/S WOCKHARDT LTD 29470 CLARIFICATION 4 M/S ROCHE PRODUCTS INDIA PVT, LTD 5 M/S BHARAT BIOTECH INTERNATIONAL LTD 26106 ACKNOWLEDGE 13603 ACKNOWLEDGE 6 M/S RELIANCE LIFE SCIENCES INVITATION

PVT, LTD 7 M/S BHARAT SERUM AND VACCINE LTD 8 M/S NOVO NORDISK INDIA PVT, LTD 9 M/S SHANTHA BIOTECHNICS LTD INVITATION INVITATION INVITATION 10 M/S GSK PVT, LTD INVITATION BE NOC FOR EXPORT S. NO. NAME OF THE COMPANY REF. NO. TYPE OF 1. *M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 2. *M/S. ACCUTEST RESEARCH LABORATORIES (I) PVT. LTD., NAVI MUMBAI-400 709 3. *M/S. ALKEM LABORATORIES LTD., TALOJA-410 208, TAL: PANVEL, DIST: RAIGAD 4. *M/S. ALKEM LABORATORIES LTD., TALOJA-410 208, TAL: PANVEL, DIST: RAIGAD 5. *M/S. ALKEM LABORATORIES LTD., TALOJA-410 208, TAL: PANVEL, DIST: RAIGAD 6. *M/S. ALKEM LABORATORIES LTD., TALOJA-410 208, TAL: PANVEL, DIST: RAIGAD 7. *M/S. ANACIPHER CLINICAL RESEARCH ORGANISATION (A DIVISION OF INDOCO 31642 CLARIFICATION 25742 APPROVAL 31489 CLARIFICATION 31496 APPROVAL 31851 APPROVAL 31848 APPROVAL 31559 APPROVAL

REMEDIES LTD.), HYDERABAD- 500 013 8. *M/S. ANACIPHER CLINICAL RESEARCH ORGANISATION, HYDERABAD-500 013 9. M/S. APL RESEARCH CENTER, HYDERABAD-500 038 10. *M/S. APOTEX RESEARCH PVT. LTD., BANGALORE-560 099 11. *M/S. APOTEX RESEARCH PVT. LTD., BANGALORE-560 099 12. M/S. AZIDUS LABORATORIES LTD., CHENNAI-600 048 13. *M/S. CIPLA LIMITED, MUMBAI-400 013 14. *M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 15. *M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 16. *M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 17. *M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD-380 054 18. M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD-500 034 19. M/S. DR. REDDY'S LABORATORIES LTD., HYDERABAD-500 034 31540 CLARIFICATION 31644 CLARIFICATION 31434 CLARIFICATION 28018 APPROVAL 31340 CLARIFICATION 31359 CLARIFICATION 31429 CLARIFICATION 31461 APPROVAL 31462 APPROVAL 31470 APPROVAL 31715 APPROVAL 31425 CLARIFICATION

20. *M/S. FAMY CARE LTD., MUMBAI-400 001 21. M/S. GLENMARK PHARMACEUTICALS LTD., NAVI MUMBAI-400 705 22. M/S. HETERO LABS LTD., HYDERABAD-500 018 23. M/S. HETERO LABS LTD., HYDERABAD-500 018 24. M/S. KUSUM HEALTHCARE PVT. LTD., NEW DELHI-110 020 25. *M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD- 380 061 26. *M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD- 380 061 27. *M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD- 380 061 28. M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI (EAST), MUMBAI- 400 059 29. *M/S. MANIPAL ACUNOVA LIMITED, MANIPAL -576104 30. *M/S. MANIPAL ACUNOVA LTD., MANGALORE-575 001 31. M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD., CHENNAI-600 044 32. M/S. MYLAN LABORATORIES LIMITED, BANGALORE-560 076 29167 CLARIFICATION 31757 APPROVAL 31883 CLARIFICATION 33333 APPROVAL 5866 APPROVAL 31487 CLARIFICATION 27381 REJECTION 31488 TEST LICENCE 34272 APPROVAL 24216 TEST LICENCE 31731 CLARIFICATION 31759 CLARIFICATION 28137 REJECTION

33. M/S. PAR BIOSCIENCES PRIVATE LIMITED, CHENNAI- 600100 34. *M/S. SEMLER RESEARCH CENTER PVT. LTD., BANGALORE-560078 31408 APPROVAL 31451 APPROVAL 35. *M/S. SIDMAK LABORATORIES (INDIA) PVT. LTD., VALSAD-396 001 FTS NO. 46776 CLARIFICATION 36. *M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD-380 015 37. *M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD-380 015 38. *M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI-400614 31621 APPROVAL 25896 APPROVAL 24738 APPROVAL *Above letters sent via email also.