LETTERS FOR ISSUE ON 20.12.2017 GLOBAL CLINICAL TRIAL SR. NO. COMPANY NAME REFERENCE NO. STATUS 1 M/S. ELI LILLY 29559 PA APPROVAL LETTER 2 M/S. NOVARTIS 26200 SITE APPROVAL LETTER MEDICAL DEVICE DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. BECTON DICKINSON INDIA PVT. LTD., 32639 LETTER 2. M/S. DSS IMAGE TECH PVT. LTD., 54449 LETTER 3. THE DRUGS CONTROLLER, BANGALORE (CLAA) THE DEPUTY DRUGS CONTROLLER, BANGALORE M/S. BIORAD MEDISYS PVT. LTD., NIL QUERY LETTER 4. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) M/S. SIORA SURGICALS PVT. LTD., NIL QUERY LETTER 5. THE JOINT COMMISSIONER (P.D.) GURUWAR PETH (CLAA) 51348 APPROVAL LETTER THE DEPUTY DRUGS CONTROLLER, MUMBAI (M/S. NIPRO INDIA CORPORATION PVT. LTD.,) 6. THE DRUGS LICENSING AUTHORITY, DEHRADUN (CLAA) 53505 APPROVAL LETTER
(M/S. GLOBAL MEDIKIT LTD.,) 7. THE DRUGS LICENSING & CONTROLLING AUTHORITY, LUCKNOW (CLAA) 44127 APPROVAL LETTER (M/S. GEEMED HEALTHCARE) 8. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) 52541 APPROVAL LETTER (M/S. DISPOSAFE HEALTH AND LIFE CARE LTD.,) 9. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) 56884 APPROVAL LETTER (M/S. MEDI PLUS INDIA LTD.,) 10. THE COMMISSIONER, GANDHINAGAR (CLAA) 49849 APPROVAL LETTER THE DEPUTY DRUGS CONTROLLER, AHMEDABAD (M/S. MERIL LIFE SCIENCES PVT. LTD.,) 11. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) 56395 APPROVAL LETTER (M/S. BECTON DICKINSON INDIA PVT. LTD.,) 12. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) 57340 APPROVAL LETTER THE DEPUTY DRUGS CONTROLLER GHAZIABAD (M/S. PRYMAX HEALTHCARE LLP) 13. THE COMMISSIONER, GANDHINAGAR (CLAA) 54579 APPROVAL LETTER THE DEPUTY DRUGS CONTROLLER, AHMEDABAD (M/S. ENVISION SCIENTIFIC PVT. LTD.,) 14. THE JOINT COMMISSIONER & LICENSING AUTHORITY 49777 QUERY LETTER
(P.D) PUNE (CLAA) M/S. ORTHOCARE & CURE (I) PVT. LTD., 15. THE STATE DRUGS CONTROLLER, PANCHKULA (CLAA) 56406 APPROVAL LETTER (M/S. HINDUSTAN SYRINGES & MEDICAL DEVICES LTD.,) 16. THE COMMISSIONER, GANDHINAGAR (CLAA) 57252 QUERY LETTER THE DEPUTY DRUGS CONTROLLER, AHMEDABAD M/S. MECCA INDUSTRIES. DIAGNOSTIC DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. GENOME DIAGNOSTICS PVT. LTD., 30280 NOC LETTER THE STATE DRUGS CONTROLLER, BADDI 2. M/S. PICTOR DIAGNOSTICS INDIA PVT. LTD., 31789 APPROVAL LETTER (T.L) ALL PORT OFFICE OF CDSCO, THE DIRECTOR, NIB, NOIDA 3. M/S. SIEMENS HEALTHCARE PVT. LTD., 32367 APPROVAL LETTER (T.L) ALL PORT OFFICE OF CDSCO NEW DRUG S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. M/S. SPECTRUM ONCOLOGY PVT - LETTER LTD. 2. M/S. IMAGING PRODUCT (I) PVT LTD. - QUERY LETTER
FDC DIVISION S.NO. NAME OF COMPANY DIARY NO. DOCUMENT 1. M/S. KOYE PHARMACEUTICALS NIL LETTER 2. M/S. PURE & CURE HEALTHCARE NIL/10369/25633 03 LETTERS 3. M/S. AKSIGEN HOSPITAL CARE 25902 LETTER SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF LETTER 1. M/S MICRO LABS LIMITED 2. M/S ACME FORMULATION 3. M/S IPCA LABORATORIES 27137 48287 IPC NOC 27127 48265 IPC NOC, DEFICIENCY LETTER 23909 43987 LETTER BIOLOGICAL DIVISION S. NO. NAME OF FIRM REFERENCE NO. TYPE OF LETTER 1 M/S BIOCON LTD 43718 (FTS NO) APPROVAL LETTER 2 M/S REGENERATIVE MEDICAL CLARIFICATION LETTER SERVICES PVT, LTD 3 M/S SANOFI PASTEUR INDIA PVT, 30816, 29485 AMENDMENT LETTER LTD 4 M/S GSK PHARMACEUTICALS LTD 22892 AMENDMENT LETTER 5 M/S APOTEX RESEARCH PVT, LTD 31426, 31428, 31427 APPROVAL LETTER 6 M/S JOHNSON & JOHNSON LTD 23308 CLARIFICATION LETTER LETTER PERTAINING TO SHELF LIFE S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. M/S. NEULAND LABORATORIES LTD. NIL LETTER FDC DIVISION S.NO. NAME OF COMPANY DIARY NO. DOCUMENT 1. M/S. KOYE PHARMACEUTICALS NIL LETTER 2. M/S. PURE & CURE HEALTHCARE NIL LETTER BE NOC FOR EXPORT S. NO. NAME OF THE COMPANY REF. NO. TYPE OF LETTER 1. M/S. ACTIMUS BIOSCIENCES PVT. LTD., VISAKHAPATNAM- 530003 2. M/S. ACTIMUS BIOSCIENCES PVT. LTD., VISAKHAPATNAM- 530003 32152 TEST LICENCE 28604 AMENDMENT LETTER 3. M/S. CLIANTHA RESEARCH LIMITED. AHMEDABAD-380054 32158 AMENDMENT LETTER 4. M/S. QUEST CARE PVT. LTD., KUTCH, GUJARAT-370230 32162 CLARIFICATION LETTER 5. M/S. QUEST CARE PVT. LTD., KUTCH, GUJARAT-370230 32161 CLARIFICATION LETTER 6. M/S. SUN PHARMACEUTICALS INDUSTRIES LTD., GUJRAT- 39020 7. M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD- 380015 31122 AMENDMENT LETTER 32155 AMENDMENT LETTER 8. M/S. VIMTA LABS LIMITED, HYDERABAD-500051 31943 REJECTION LETTER LVP DIVISION S. NO. COMPANY NAME FTS NO. /DIARY NO. STATUS 01 M/S. ACULIFE HEALTHCARE PVT. LTD., SACHANA, GUJ. 49778, 49779 APPROVAL 02 M/S ONCO THERAPIES LIMITED, BANGALORE 40264 APPROVAL
03 M/S MYLAN LABORATORIES LIMITED, BANGALORE 04 M/S TAJ PHARMACEUTICALS LTD. C/O M/S SHREE KRISHNA KESHAV LAB. LTD., AHMEDABAD 05 M/S HEALTHLINE PHARMACEUTICALS INDUSTRIES LIMITED, SANGUR 52149 APPROVAL 54026 QUERY 52015 APPROVAL