LETTERS FOR ISSUE ON

Transcription

1 LETTERS FOR ISSUE ON BIOLOGICAL DIVISION S. NO. NAME OF COMPANY DY. NO. STATUS 1 M/S GLOBION INDIA PVT, LTD 2 M/S PANACEA BIOTECH LTD CLARIFICATION LETTER 989 CLARIFICATION LETTER 3 M/S VIMTA LABS LTD 7638 CLARIFICATION LETTER 4 M/S ELI LILLY AND COMPANY INDIA PVT, LTD 5 M/S CEVA ANIMAL HEALTH INDIA PVT, LTD 6 M/S INTERVET INDIA PVT, LTD 7 M/S BHARAT SERUM AND VACCINES LTD 8 M/S INDIAN IMMUNOLOGICAL LTD 9 M/S NOVO NORDISK INDIA PVT, LTD 10 M/S SANDORMEDICAIDS PVT, LTD 11 M/S PROSPER CHANNEL LIFESCIENCES INDIA PVT, LTD 12 M/S MSD PHARMACEUTICALS PVT, LTD 13 M/S DR. REDDY S LABORATORIES. LTD 7790 CLARIFICATION LETTER 8261 CLARIFICATION LETTER CLARIFICATION LETTER 7646 CLARIFICATION LETTER 1874 CLARIFICATION LETTER 2476 CLARIFICATION LETTER 3929 CLARIFICATION LETTER 4965 CLARIFICATION LETTER

2 14 M/S WOCKHARDT LTD 3941 SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF LETTER 1. M/S ABOTT HEALTHCARE DEFICIENCY LETTER 2. M/S ZIM LABORATORIES DEFICIENCY LETTER 3. M/S ALLERGAN INDIA DEFICIENCY LETTER 4. M/S INTAS 3544, , 2679 DEFICIENCY LETTER (2) PHARMACEUTICALS 5. M/S CLIANTHA RESEARCH DEFICIENCY LETTER 6. M/S LINCOLN DEFICIENCY LETTER PHARMACEUTICALS 7. M/S ALKEM LABORATORIES DEFICIENCY LETTER 8. M/S GSK DEFICIENCY LETTER 9. M/S EMCURE DEFICIENCY LETTER 10. M/S WINDLAS BIOTECH DEFICIENCY LETTER 11. M/S CAPSUGEL HEALTHCARE DEFICIENCY LETTER 12. M/S DR. REDDY S DEFICIENCY LETTER LABORATORIES 13. M/S NEW INDIA BIOPHARMA DEFICIENCY LETTER 14. M/S VIRCHOW BIOTECH DEFICIENCY LETTER 15. M/S HETERO 4539, 4540, , 7824, 1634 DEFICIENCY LETTER (3) 16. M/S CIPLA DEFICIENCY LETTER 17. M/S SANOFI-SYNTHELABO DEFICIENCY LETTER IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. HARESH OVETA SANOFI INDIA 40861, REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. JOHNSON & JOHNOSN PVT. 84

3 COSMETIC DIVISION S. NO. COMPANY NAME DIARY NO. STATUS 1. M/S. COLGATE PALMOLIVE INDIA LTD, MUMBAI M/S. BACCAROSE PERFUMES & BEAUTY PRODUCTS PVT. LTD, MUMBAI M/S. QUEST RETAIL PVT. LTD, JAIPUR M/S. VS SALES, MUMBAI M/S. EVERSTYLE HOTEL SUPPLIES INDIA PVT. LTD, GURGAON M/S. BELLEZA ENTERPRISES PVT. LTD, MUMBAI M/S. BACCAROSE PERFUMES & BEAUTY PRODUCTS PVT. LTD, MUMBAI M/S. SKIN COSMEDICA LLP, MUMBAI M/S. STREAMLINE SERVICES INDIA, WEST BENGAL M/S. MARKS AND SPENCER RELIANCE INDIA PVT. LTD, GURGAON 11. M/S. BEAUBELLE PRODUCTS AND CARE PVT. LTD, CHENNAI 6759, INTERNATIONAL CELL S. NO FIRM NAME TYPE 01. M/S. SHILPA MEDICARE LIMITED, KARNATAKA LETTER NEW DRUG S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER 1. M/S. EXCEL LIFE SCIENCES PVT LTD - LETTER

4 2. M/S. INTAS PHARMACEUTICALS - CT-NOC LETTER (2) 3. M/S. AJANTA PHARMA LTD - QUERY LETTER 4. M/S. NOVARTIS HEALTHCARE PVT - LETTER (3) LTD 5. M/S. GURMIL BROTHERS - IPC LETTER MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. AMARDEEP ENTERPRISES 781 APPROVAL (F-RC) 2. ` M/S. ALLIED TRADE HOUSE 6244 APPROVAL (F-IL) 3. M/S. ALLIED TRADE HOUSE 6239 APPROVAL (F-IL) 4. M/S. BHARAT SERUM & VACCINES LIMITED 7198 APPROVAL (R-IL) 5. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (F-RC) 6. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (F-IL) 7. M/S. BOSTON SCIENTIFIC INDIA PVT APPROVAL (E-RC) 8. M/S. BOSTON SCIENTIFIC INDIA PVT APPROVAL (E-IL) 9. M/S. BOSTON SCIENTIFIC INDIA PVT LETTER 10. M/S. BOSTON SCIENTIFIC INDIA PVT. 863 LETTER ALL ZONAL / SUB ZONAL OFFICES OF CDSCO 11. M/S. CARL ZEISS INDIA (BANGALORE) PVT APPROVAL (R-RC) 12. M/S. CAMBINDIA BIOTECH KITS PVT APPROVAL (F-RC) 13. M/S. CLINIEXPERTS SERVICES PVT. 814 APPROVAL (F-RC) 14. M/S. COVIDIEN HEALTHCARE INDIA PVT. 663 APPROVAL (R-E-IL) 15. M/S. COVIDIEN HEALTHCARE INDIA PVT CLARIFICATION LETTER 16. M/S. COVIDIEN HEALTHCARE INDIA PVT APPROVAL (R-E-RC) 17. M/S. COVIDIEN HEALTHCARE INDIA PVT APPROVAL (R-E-IL) 18. M/S. DELHI EYE ZONE PVT APPROVAL (F-IL)

5 19. M/S. EMERGO (INDIA) CONSULTING PVT APPROVAL (F-RC) 20. M/S. EMERGO (INDIA) CONSULTING PVT APPROVAL (R-RC) 21. M/S. ENDOVASCULAR CORPORATION PVT. 22. M/S. ENDOVASCULAR CORPORATION PVT. 23. M/S. ENDOVASCULAR CORPORATION PVT APPROVAL (F-RC) 3019 APPROVAL (F-IL) LETTER 24. M/S. EVENT MEDI SYSTEMS APPROVAL (R-RC) 25. M/S. EVENT MEDI SYSTEMS APPROVAL (R-IL) 26. M/S. FERON LIFE SCIENCES (P) APPROVAL (F-IL) 27. M/S. FERON LIFE SCIENCES (P) LETTER 28. M/S. FRESENIUS MEDICAL CARE (INDIA) PVT. 29. M/S. FRESENIUS MEDICAL CARE (INDIA) PVT APPROVAL (R-RC) 2470 APPROVAL (R-IL) 30. M/S. INDIA MEDTRONIC PVT APPROVAL (R-E-RC) 31. M/S. INDIA MEDTRONIC PVT APPROVAL (R-E-IL) 32. M/S. ILIFE MEDICAL DEVICES PVT THE STATE DRUGS CONTROLLER, PANCHKULA 33. M/S. JOHNSON & JOHNSON PVT APPROVAL (R-E-RC) 34. M/S. JOHNSON & JOHNSON PVT APPROVAL (R-E-IL) 35. M/S. JOHNSON & JOHNSON PVT APPROVAL (E-RC) 36. M/S. JOHNSON & JOHNSON PVT APPROVAL (E-IL) 37. M/S. JOHNSON & JOHNSON PVT APPROVAL (E-RC) 38. M/S. JOHNSON & JOHNSON PVT APPROVAL (E-IL) 39. M/S. MATSON SURGICALS PVT APPROVAL (F-IL) 40. M/S. MATSON SURGICALS PVT APPROVAL (F-IL) 41. M/S. MEDEVOLUTION DEVICES PVT APPROVAL (F-RC)

6 42. M/S. MN SOLUTIONS 2090 APPROVAL (F-RC) 43. M/S. NATEC MEDICAL PVT APPROVAL (R-RC) 44. M/S. NATEC MEDICAL PVT APPROVAL (R-IL) 45. M/S. NORIS MEDICAL PVT APPROVAL (F-IL) 46. M/S. PEERLESS BIOTECH PVT APPROVAL (F-RC) 47. M/S. RELIANCE LIFE SCIENCE PVT APPROVAL (R-IL) 48. M/S. ROMSONS SCIENTIFIC AND SURGICAL INDUSTRIES PVT. 49. M/S. ROMSONS SCIENTIFIC AND SURGICAL INDUSTRIES PVT APPROVAL (F-RC) APPROVAL (F-IL) 50. M/S. SMITHS MEDICAL INDIA PVT APPROVAL (F-RC) 51. M/S. SMITHS MEDICAL INDIA PVT APPROVAL (F-IL) 52. M/S. SHREYAAS HEALTHCARE 8467 APPROVAL (F-RC) 53. M/S. SHREYAAS HEALTHCARE 8467 APPROVAL (F-IL) 54. M/S. TELEFLEX MEDICAL PVT APPROVAL (R-IL) 55. M/S. TRANSLUMINA THERAPEUTICS LLP 2684 APPROVAL (F-RC) 56. M/S. TRANSLUMINA THERAPEUTICS LLP 2684 APPROVAL (F-IL) 57. M/S. VISHAL SURGICAL EQUIPMENT CO. PVT APPROVAL (R-IL) 58. M/S. VASCULAR CONCEPTS LTD APPROVAL (R-IL) 59. M/S. VASCULAR CONCEPTS LTD APPROVAL (R-RC) 60. M/S. VEIVA SCIENTIFIC INDIA PVT APPROVAL (E-IL) 61. M/S. MACOPHARMA INDIA TRANSFUSION SOLUTIONS PVT APPROVAL (TEST 62. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (E-RC) 63. M/S. BARD INDIA HEALTHCARE PVT APPROVAL (E-IL) 64. M/S. AGKEM IMPEX PVT CLARIFICATION LETTER 65. ALL PORT OFFICES OF CDSCO M/S. BOSTON SCIENTIFIC INDIA PVT. NIL LETTER

7 66. ALL PORT OFFICES OF CDSCO M/S. BOSTON SCIENTIFIC INDIA PVT. NIL LETTER 67. M/S. BOSTON SCIENTIFIC INDIA PVT LETTER 68. M/S. BEST HEARING SOLUTIONS LETTER M/S. ZHEJIAN NEUTRON BIOTECHNOLOGY CO., CHINA ALL PORT OFFICES OF CDSCO 69. M/S. BIOSENSORS INTERVENTIONAL TECHNOLOGIES (I) PVT LETTER 70. CHIEF MEDICAL OFFICER SAWAI MAAN SINGH HOSPITAL FTS. NO LETTER 71. M/S. INDIA MEDTRONIC PVT LETTER 72. M/S. GREINER BIO-ONE (INDIA) PVT CLARIFICATION LETTER 73. M/S. SHAKTI KNITTING LIMITED THE DEPUTY DRUGS CONTROLLLER, CHENNAI FTS. NO CLARIFICATION LETTER 74. M/S. SURYA SURGICAL INDUSTRIES 6569 LETTER 75. M/S. SURGIPLUS 4099 CLARIFICATION LETTER 76. M/S. MERIL LIFE SCIENCES PVT., THE COMMISSIONER, GANDHINAGAR, 77. THE COMMISSIONER, GANDHINAGAR, (M/S. SAHAJANAND MEDICAL TECHNOLOGIES PVT., SURAT) 78. THE COMMISSIONER, GANDHINAGAR, (M/S. SAHAJANAND MEDICAL TECHNOLOGIES FTS. NO FTS. NO LETTER

8 PVT., SURAT) 79. M/S. MERIL LIFE SCIENCES PVT., THE COMMISSIONER, GANDHINAGAR, 80. THE COMMISSIONER, GANDHINAGAR, (M/S. MERIL LIFE SCIENCES PVT., VALSAD) 81. THE COMMISSIONER, GANDHINAGAR, (M/S. MERIL LIFE SCIENCES PVT., VAPI) FTS. NO LETTER 82. THE COMMISSIONER, GANDHINAGAR, (M/S. MERIL LIFE SCIENCES PVT., VAPI) 83. THE COMMISSIONER, GANDHINAGAR, (M/S. MERIL LIFE SCIENCES PVT., VAPI) 84. THE STATE DRUGS CONTROLLER, PANCHKULA GHAZIABAD (M/S. POLY MEDICURE ) 85. THE DRUGS LICENSING AUTHORITY, DEHRADUN, GHAZIABAD

9 (M/S. GLOBAL MEDIKIT, DEHRADUN) 86. M/S. NANO THERAPEUTICS PVT LETTER THE COMMISSIONER, GANDHINAGAR 87. THE STATE DRUGS CONTROLLER, PANCHKULA GHAZIABAD (M/S. ILIFE MEDICAL DEVICES PVT., SONEPAT) DIAGNOSTICS DIVISION S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. ABBOTT HEALTHCARE PVT APPROVAL (R-E-RC) 2. M/S. ABBOTT HEALTHCARE PVT APPROVAL (R-E-IL) 3. M/S. ABBOTT HEALTHCARE PVT QUERY LETTER 4. M/S. GRIFOLS INDIA HEALTHCARE PVT APPROVAL (F-RC) 5. M/S. GRIFOLS INDIA HEALTHCARE PVT APPROVAL (F-IL) 6. M/S. BANGALORE MEDICAL SYSTEMS PHARMACEUTICAL DISTRIBUTORS 5854 APPROVAL (F-IL) 7. M/S. HEMOGENOMICS PVT APPROVAL (F-IL) 8. M/S. GREEN APPLE MEDICAL SYSTEMS 5854 APPROVAL (F-IL) 9. M/S. BECKMAN COULTER PVT APPROVAL (E-IL) 10. M/S. IMMUNOCONCEPT INDIA PVT APPROVAL (IL) 11. M/S. LAB INDIA HEALTHCARE PVT APPROVAL (IL) 12. M/S. NANZ MED SCIENCE PHARMA PVT APPROVAL (IL) 13. M/S. ORTHO CLINICAL DIAGNOSTICS INDIA PVT APPROVAL (IL) 14. M/S. ORTHO CLINICAL DIAGNOSTICS INDIA PVT LETTER 15. M/S. POLCHEM HYGIENE LABORATORIES PVT. 615 APPROVAL (IL)

10 16. M/S. RAPID DIAGNOSTICS PVT. 49 APPROVAL (IL) 17. M/S. RENNEX MEDICAL 6220 APPROVAL (IL) 18. M/S. EQUINOX OVERSEAS PVT APPROVAL (TEST 19. M/S. JEEV DIAGNOSTICS PVT APPROVAL (TEST 20. M/S. JOHNSON & JOHNSON PVT APPROVAL (TEST 21. M/S. JOHNSON & JOHNSON PVT APPROVAL (TEST 22. M/S. MICROGENE DIAGNOSTICS SYSTEMS PVT APPROVAL (TEST 23. M/S. THERMO FISHER SCIENTIFIC INDIA PVT APPROVAL (IL) 24. M/S. DIAGNOCURE (INDIA) 6127 LETTER 25. M/S. J. MITRA & CO. PVT QUERY LETTER 26. M/S. N.W. OVERSEAS 6268 QUERY LETTER 27. M/S. PINNACLE BIOMED PVT LETTER 28. M/S. SIEMENS LIMITED 3852 LETTER 29. M/S. TOSOH INDIA PVT LETTER 30. M/S. THROMBOCHEK LABS PVT QUERY LETTER 31. M/S. N. W. OVERSEAS 6269 CLARIFICATION LETTER