LETTERS FOR ISSUE ON

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1 S FOR ISSUE ON INTERNATIONAL CELL S. NO FIRM NAME TYPE 1. M/S TYCHE INDUSTRIES LTD., ANDHRA PRADESH, INDIA IMPORT S. NAME OF APPLICANT DIARY TYPE OF 1. PIRAMAL ENTERPRISES LTD APPROVAL 2. CENTAUR PHARMACEUTICALS PVT APPROVAL LTD. 3. CADILA PHARMACEUTICALS LTD APPROVAL 4. SANDOZ PRIVATE LIMITED APPROVAL 5. ASTRAZENECA PHARMA INDIA APPROVAL LIMITED 6. GLAXO SMITHKLINE APPROVAL PHARMACEUTICALS LTD., 7. FRESENIUS KABI INDIA PVT.LTD APPROVAL 8. SHAMSHREE LIFESCIENCES LTD APPROVAL 9. SHAMSHREE LIFESCIENCES LTD APPROVAL 10. SHAMSHREE LIFESCIENCES LTD APPROVAL 11. ENVEE DRUGS PRIVATE LIMITED APPROVAL 12. PRATISTHA PHARMA APPROVAL 13. SUN PHARMA LABORATORIES LTD APPROVAL 14. AQUATIC REMEDIES PVT. LTD APPROVAL 15. GENERAL IMPORT COMPANY APPROVAL (INDIA) PVT. LTD. 16. SHREENATH CHEMICALS APPROVAL 17. FARMACHEM LIFE PRIVATE AMENDED LIMITED 18. FARMACHEM LIFE PRIVATE AMENDED LIMITED 19. PRADIPKUMAR PHARMA PVT. LTD CLARIFICATION 20. ZYDUS HEALTHCARE B.M.CHEMIE CLARIFICATION 22. CADILA HEALTHCARE LIMITED CADILA HEALTHCARE LIMITED 25356

2 24. ADCOCK INGRAM HEALTHCARE PVT. LTD., 25. BAXTER (INDIA) PVT. LTD. REGISTRATION S. NAME OF APPLICANT DIARY TYPE OF 1. MODI MUNDIPHARMA PVT. LTD. NIL MEDICAL DEVICE S. COMPANY NAME DIARY NO STATUS 1. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD APPROVAL (F-RC) 2. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD APPROVAL (F-IL) 3. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD CLARIFICATION 4. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD QUERY 5. M/S. CONFIDENT SALES INDIA PVT. LTD APPROVAL (E-IL) 6. M/S. FORTIS ESCORTS HEART INSTITUTE & RESEARCH CENTRE NIL APPROVAL 7. M/S. SPAN HEALTHCARE PVT. LTD APPROVAL (F-IL) 8. M/S. SUTURES INDIA PVT. LTD APPROVAL (R-IL) 9. M/S. ZIMMER INDIA PVT. LTD APPROVAL (R-RC) 10. M/S. ZIMMER INDIA PVT. LTD APPROVAL (R-IL) 11. M/S. ABBOTT HEALTHCARE PVT. LTD M/S. B. BRAUN MEDICAL (INDIA ) PVT. LTD M/S. CENTENIAL SURGICAL SUTURE LTD M/S. EMERGO (INDIA) CONSULTING PVT. LTD M/S. MORULLAHEALTHTECH PVT. LTD CLARIFICATION

3 16. M/S. TIMPAC HEALTHCARE PVT. LTD CLARIFICATION 17. M/S. JOHNSON & JOHNSON PVT. LTD THE DIRECTOR OF DRUGS CONTROL, CHENNAI (CLAA) APPROVAL THE DEPUTY DRUGS CONTROLLER (I), CHENNAI (CLAA) M/S. EXCELLENT HI-CARE PVT. LTD. 19. THE COMMISSIONER, GANDHINAGAR (CLAA) THE ASSISTANT DRUGS CONTROLLER(I), AHMEDABAD (CLAA) APPROVAL M/S. M/S. MRK HEALTHCARE PVT. LTD. 20. THE JOINT DIRECTOR & LICENSING AUTHORITY, HYDERABAD (CLAA) APPROVAL CDSCO SUB ZONE OFFICE, HYDERABAD (CLAA) M/S. RELISYS MEDICAL DEVICE LIMITED, ANDHRA PRADESH 21. THE STATE DRUGS CONTROLLER, DELHI (CLAA) THE DEPUTY DRUGS CONTROLLER(I), GHAZIABAD (CLAA) M/S. PASECA HEALTHCARE LLP, NEW DELHI NIL QUERY DIAGNOSTICS DIVISION S. COMPANY NAME DIARY NO STATUS

4 1. M/S. BIO STATE APPROVAL (IL) 2. M/S. MERIL DIAGNOSTICS PVT. LTD QUERY 3. M/S. RAPID DIAGNOSTICS PVT. LTD APPROVAL (IL) 4. M/S. RAPID DIAGNOSTICS PVT. LTD APPROVAL (IL) 5. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD M/S. SYSMEX INDIA PVT. LTD APPROVAL (IL) 7. M/S. TRANSASIA BIO-MEDICALS LIMITED APPROVAL (IL) 8. M/S. VISHAT DIAGNOSTICS PVT. LTD APPROVAL (IL) 9. M/S. VISHAT DIAGNOSTICS PVT. LTD APPROVAL (IL) 10. M/S. SIEMENS LIMITED NIL 11. M/S. BIOMERIEUX INDIA PVT. LTD. NIL 12. M/S. CPC DIAGNOSTICS PVT. LTD. NIL 13. M/S. MERIL DIAGNOSTICS PVT. LTD. NIL 14. M/S. PIRAMAL ENTERPRISES LTD. NIL 15. M/S. STEDMAN PHARMACEUTICALS PVT. LTD. NIL 16. M/S. THERMO FISHER SCIENTIFIC INDIA PVT. LTD. NIL 17. M/S. PHADIA INDIA PVT. LTD. NIL 18. M/S. NUCLEUS INC. NIL FDC DIVISION S. NAME OF COMPANY DIARY NO DOCUMENT 1. M/S. BONN SCHETRING BIOSCIENCES, NIL 2. M/S. MICRO LABS LTD., LVP DIVISION

5 S. COMPANY NAME FTS /DIARY STATUS 01 M/S. CHEMO HEALTHCARE PVT. LTD., C/O. M/S. AMANTA HEALTHCARE, GUJARAT 02 M/S. AMANTA HEALTHCARE LIMITED,GUJARAT 03 M/S. AKUMS DRUGS & PHARMACEUTICALS LTD, HARIDWAR 04 M/S. UNIQUE PHARMACEUTICALS LABORATORIES, GUJARAT 03 M/S. SHILIPA MEDICARE LIMITED, TELANGANA APPROVAL APPROVAL APPROVAL APPROVAL QUERY VACCINE DIVISION S. COMPANY NAME DY. NO STATUS 1 M/S BHARAT BIOTECH INTERNATIONAL LTD 2 M/S RELIANCE LIFE SCIENCES PVT, LTD 24491, APPROVAL APPROVAL 3 M/S BIOCON LTD 25579, APPROVAL 4 M/S NOVARTIS HEALTHCARE PVT, LTD 5 M/S ELI LILLY AND COMPANY INDIA PVT, LTD 24379, APPROVAL 6989 APPROVAL VACCINE S. COMPANY NAME DY. NO STATUS

6 1 M/S BHARAT BIOTECH INTERNATIONAL LTD 2 M/S. BIOLOGICAL-E LTD 3 M/S. BIOMED PVT. LTD 4 M/S. CADILA HEALTH CARE LTD 5 M/S. CHIRON BEHRING VACCINES PVT. LTD 6 M/S. DANO VACCINES & BIOLOGICALS PVT. LTD 7 M/S. GREEN SIGNAL BIO PHARMA PVT. LTD 8 M/S. PANACEA BIOTEC LTD 9 M/S. RANBAXY LAB, 10 M/S. SERUM INSTITUTE OF INDIA LTD. 11 SHANTHA BIOTECHNICS LTD 12 M/S. BHARAT IMMUNOLOGICAL & BIOLOGICAL CORPORATION LTD 13 M/S. HAFFKINE BIO PHARMACEUTICAL CORPORATION LTD 14 M/S. HUMAN BIOLOGICAL INSTITUTUTE 15 M/S. HLL BIOTECH LTD., HLL BIOTECH LTD 16 M/S. SANOFI PASTEUR INDIA PVT LTD 17 M/S. GSK ASIA PVT LTD 18 M/S. PASTEUR INSTITUTE OF INDIA,

7 19 M/S. BCG VACCINE LABORATORY 20 M /S. CENTRAL RESEARCH INSTITUTE SUBSEQUENT NEW DRUG S. NAME OF THE FIRM REFERENCE FTS TYPE OF 1. M/S OLIVE DEFICIENCY HEALTHCARE., 2. M/S CIPLA LTD., DEFICIENCY 3. M/S AQUA VITOELABORATORIES., 4. M/S THEMIS MEDICARE LTD., 5. M/S MSN LABORATORIES PVT. LTD., 6. M/S ANTHEM BIOSCIENCES PVT. LTD., 7. M/S AJANTA PHARMA LTD., APPROVAL 21443, DEFICIENCY (2) DEFICIENCY DEFICIENCY DEFICIENCY INTERNATIONAL CELL S. NO FIRM NAME TYPE 1. M/S INTAS PHARMACEUTICALS LTD., AHMEDABAD NOC 2. M/S D.K. PHARMACHEM, THANE, MAHARASHTRA

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