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1 S FOR ISSUE ON NEW DRUG S. NAME OF APPLICANT DIARY TYPE OF 1. M/S. INTAS PHARMACEUTICALS LIMITED - CT NOC (2) 2. M/S. PFIZER LIMITED - QUERY 3. M/S. MSN LABORATORIES - ADDITIONAL SITE 4. M/S. ELI LILLY ASIA INC. - QUERY MEDICAL DEVICE S. COMPANY NAME DIARY NO STATUS 1. M/S. PAUL HARTMANN MEDICAL PVT. LTD APPROVAL (R-RC) 2. M/S. GENOME DIAGNOSTICS PVT. LTD. NIL DIAGNOSTICS DIVISION S. COMPANY NAME DIARY NO STATUS 1. M/S. SAIFY TRADERS APPROVAL (IL) 2. M/S. SIEMENS LIMITED NIL 3. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. NIL VACCINE DIVISION S. COMPANY NAME DY. NO STATUS 1 M/S WOCKHARDT LTD 23593, (FTS NO) CLARIFICATION 2 M/S JOHNSON & JOHNSON LTD CLARIFICATION
2 3 M/S SANZYME CLARIFICATION 4 M/S NOVARTIS HEALTHCARE 5 M/S BHARAT BIOTECH INTERNATIONAL LTD CLARIFICATION CLARIFICATION 6 M/S BIOCON LTD CLARIFICATION 7 M/S BIOMED CLARIFICATION 8 M/S SANOFI SYNTHELABO INDIA LTD CLARIFICATION 9 M/S BIOCON LTD CLARIFICATION 10 M/S VITA PHARMA AGENCIES CLARIFICATION 11 M/S LG LIFE SCIENCES INDIA 12 M/S NOVO MEDI SCIENCES CLARIFICATION CONTINUATION GLOBAL CLINICAL TRIAL SR. NAME OF FIRM REFERENCE TYPE OF 1. M/S. PFIZER NEW SITE 2. M/S. MAX NEEMAN CLARIFICATION 3. M/S. NOVARTIS 25270/26012/24241/2642/25270 TL/ CLARIFICATION 4. M/S. AMGEN CORRECTION IN APPROVAL 5. M/S. GEORGE CLINICAL INDIA CLARIFICATION 6. M/S. PPD AMENDMENT IN EXPORT NOC APPROVAL 7. M/S. QUINTILES TL APPROVAL
3 8. M/S. BOEHRINGER 26092/27037 CHANGE IN PI / TL APPROVAL MEDICAL DEVICE S. COMPANY NAME DIARY NO STATUS 3. M/S. BAXTER (INDIA) PVT. LTD QUERY 4. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD M/S. BOSTON SCIENTIFIC INDIA PVT. LTD QUERY 6. M/S. CLAIRVOYANCE CONSULTING M/S. JOHNSON & JOHNSON PVT. LTD M/S. JOHNSON & JOHNSON PVT. LTD QUERY 9. M/S. JOHNSON & JOHNSON PVT. LTD QUERY 10. M/S. JOHNSON & JOHNSON PVT. LTD QUERY 11. M/S. LIFECELL INTERNATIONAL PVT. LTD M/S. MN SOLUTIONS QUERY 13. M/S. ST. JUDE MEDICAL INDIA PVT. LTD QUERY 14. M/S. SKINCARE SURGIPHARMA PVT. LTD QUERY 15. M/S. ZIMMER INDIA PVT. LTD QUERY 16. M/S. ZIMMER INDIA PVT. LTD QUERY 17. ALL PORT OFFICE OF CDSCO DDC (I) OF ALL ZONAL OFFICES OF CDSCO ( OFFICE MEMORANDUM - RECALL OF EXTRACTOR PRO RX RETRIEVAL BALLOON CATHETER ) 18. M/S. PAUL HARTMANN MEDICAL PVT. LTD APPROVAL (R-RC) 19. M/S. GENOME DIAGNOSTICS PVT. LTD. NIL
4 DIAGNOSTICS DIVISION S. COMPANY NAME DIARY NO STATUS 4. M/S. BJMC CRS QUERY 5. M/S. QUALPRO DIAGNOSTICS C/O VIOLA DIAGNOSTICS SYSTEMS QUERY 6. M/S. IRIS HEALTHCARE TECHNOLOGIES PVT. LTD QUERY 7. M/S. SAIFY TRADERS APPROVAL (IL) 8. M/S. SIEMENS LIMITED NIL 9. M/S. ROCHE DIAGNOSTICS INDIA PVT. LTD. NIL REGISTRATION S. NAME OF APPLICANT DIARY TYPE OF 1. ESSCHEM PVT. LTD APPROVAL 2. SYMBIO GENERICS INDIA PVT. LTD. NIL APPROVAL 3. ALLIED PHARMA SOLUTION APPROVAL 4. UNICHEMIE INERNATIONAL 13258, AMENDMENT 5. LASCO INTERNATIONAL ` AMENDMENT 6. JOHNSON & JOHNSON GSK ASIA PVT. LTD. 8. EISAI PHARMACEUTICALS INDIA CLARIFICATION PVT. LTD. 9. RUSHI CORPORATION CLARIFICATION 10. EASTERN CHEMICAL (MUMBAI) CLARIFICATION PVT. LTD. 11. RUSKIN CHEMIPHARM CLARIFICATION 12. ASTRAZENECA PHARMA INDIA LTD CLARIFICATION 13. SHIVAM PHARMA CHEMICALS CLARIFICATION 14. FORMACHEM LIFE PVT. LTD , CLARIFICATION
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