Letters for Issue on 03.02.2015

LETTERS FOR ISSUE ON 03.02.2015

BE NOC FOR EXPORT

S. NO. / NAME OF THE COMPANY / REF. NO. / Type of letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 368 / Approval Letter
M/s. Alembic Pharmaceuticals Ltd., Vadodara-390 003 / 49424 / Approval Letter
M/s. Alkem Laboratories Ltd., Dist: Raigad / 118 / Clarification Letter
M/s. APL Research Centre, Aurobindo Pharma Ltd., Hyderabad-500 090 / 7 / Test Licence
M/s. Axis Clinical Ltd., Hyderabad-500 049 / 49361 / Approval Letter
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 151 / Test Licence
M/s. Azidus Laboratories Ltd., Chennai-600 048 / 149 / Test Licence
M/s. Cadila Healthcare Ltd.,, Ahmedabad-380 015 / 188 / Test Licence
M/s. Cadila Pharmaceutical Ltd., Dholka-387 810, Ahmedabad / 131 / Test Licence
M/s. Cipla Limited, Mumbai-400 013 / 138 / Approval Letter
M/s. Cipla Limited, Mumbai-400 013 / 143 / Approval Letter
M/s. Cliantha Research Limited, Ahmedabad-380 054 / 42155 / Approval Letter
M/s. Cliantha Research Ltd., Ahmedabad-380 054 / 128 / Clarification Letter
M/s. Clinsync Clinical Research Pvt. Ltd., Hyderabad-501 505 / 2260 / Approval Letter
M/s. Dr. Reddy’s Laboratories Ltd., Hyderabad-500 034 / 49560 / Test Licence
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 576 / Amendment Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 413 / Amendment Letter
M/s. Emcure Pharmaceuticals Limited, Pune-411 026 / 414 / Amendment Letter
M/s. Hetero Labs Ltd., Hyderabad-500 018 / 33369 / Approval Letter
M/s. Inventia Healthcare Pvt. Ltd., Thane-400 604 / 49521 / Approval Letter
M/s. Lambda Therapeutic Research Ltd., Ahmedabad-380 061 / 45 / Approval Letter
M/s. Manipal Acunova Ltd., Mangalore-575 001 / 1062 / Clarification Letter
M/s. Panexcell Clinical Lab Pvt. Ltd., Navi Mumbai-400 701 / 2083 / Approval Letter
M/s. Quest Life Sciences (P) Ltd., Chennai-600045 / 334 / Test Licence
M/s. Sipra Labs Limited, Hyderabad-500 018 / 48813 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 1692 / Approval Letter
M/s. Veeda Clinical Research Pvt. Ltd., Ahmedabad-380 015 / 127 / Approval Letter
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400 614 / 48251 / Additional Study Centre
M/s. Watson Pharma Pvt. Ltd., Navi Mumbai-400614 / 56 / Approval Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Modern Laboratories / 73326 / Letter
M/s. Aeon Formulations / 43033 / Letter
M/s. Ranbaxy Laboratories / 47507 / Letter
M/s. Gopaldas Visram / 50659 / Letter
M/s. Gopaldas Visram / 50660 / Letter
M/s. Gopaldas Visram / 50658 / Letter

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/s Glenmark Pharmaceuticals Ltd., / 481710 / - / Amendment Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
Mylan Pharmaceuticals Pvt. Ltd. / 1527 / approval Letter
C.J. Shah & Co. (Godown) / 405 / approval Letter
Micro Labs Ltd. / 497 / approval Letter
Micro Labs Ltd. / 498 / approval Letter
Dilipkumar and Company / 500 / approval Letter
Corona Remedies Pvt. Ltd. / 382 / approval Letter
Farmachem Life Pvt. Ltd. / 383 / approval Letter
Uni Medicolabs, / 381 / approval Letter
Farmachem Life Pvt. Ltd. / 575 / approval Letter
DPB Antibiotics / 576 / approval Letter
DPB Antibiotics / 547 / approval Letter
Cipla Ltd. / 532 / approval Letter
Cipla Ltd. / 531 / approval Letter
Cipla Ltd. / 676 / approval Letter
Cipla Ltd. / 677 / approval Letter
Puja Enterprises / 666 / approval Letter
Puja Enterprises / 667 / approval Letter
Cadila Healthcare Ltd. / 753 / approval Letter
Zydus Healthcare / 752 / approval Letter
Skies / 202 / approval Letter
Dilipkumar and Company / 501 / approval Letter
Puja Enterprises / 821 / approval Letter
Ruskin Chemipharm / 884 / approval Letter
Rely Chem(Godown) / 820 / approval Letter
Rely Chem(Godown) / 819 / approval Letter
Sentiss Pharma Pvt. Ltd. / 846 / approval Letter
Alves Healthcare Pvt.Ltd. / 797 / approval Letter
Ranbaxy Laboratories Ltd. / 834 / approval Letter
Ranbaxy Laboratories Ltd. / 1085 / approval Letter
T.C. Health Care Pvt. Ltd. / 1026 / approval Letter
Sagar Rubber Products Pvt. Ltd. / 1075 / approval Letter
Aquatic Remedies Pvt. Ltd. / 1074 / approval Letter
Harshada Corporation / 1076 / approval Letter
C.J. Shah & Co. (Godown) / 1078 / approval Letter
Gorang International / 1077 / approval Letter
Kalgov Labs Ltd., / 1077 / approval Letter
Gorang International / 1084 / approval Letter
General Import Company (India) Pvt. Ltd. / 1092 / approval Letter
VXL Life Sciences / 1091 / approval Letter
Medi Pharma Drug House / 1093 / approval Letter
Central Drug House / 1086 / approval Letter
Laborate Pharmaceuticals India Ltd, Unit - II / 1112 / approval Letter
Laborate Pharmaceuticals India Ltd, Unit - II / 1111 / approval Letter
Laborate Pharmaceuticals India Ltd, Unit - II / 1110 / approval Letter
Pratistha Pharma / 1080 / approval Letter
Pratistha Pharma / 1081 / approval Letter
Pratistha Pharma / 1082 / approval Letter
Pratistha Pharma / 1083 / approval Letter
Genetek Lifesciences Pvt. Ltd. / 1048 / approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 388 / approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 387 / approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 386 / approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 384 / approval Letter
Bayer Pharmaceuticals Pvt. Ltd. / 863 / approval Letter
Glaxo Smith Kline Pharmaceuticals Ltd. / 385 / approval Letter
Allergan India Pvt. Ltd. / 50242 / 06 approval Letter
Astrazeneca Pharma India Limited / 1185 / approval Letter
Lupin Limited / 1102 / approval Letter
Bayer Zydus Pharma Pvt. Ltd. / 1894 / approval Letter
Pfizer Products India Pvt.Ltd. / 50185 / approval Letter
Novartis India Limited / 50796 / approval Letter
Baxter India Pvt.Ltd. / 45346 / Amended Letter
Fulford India ltd. / 1163 / Clarification Letter
Puja Enterprises / 1754 / Clarification Letter
Pfizer Products India Pvt. Ltd. / 43864 / Clarification Letter
USB India Pvt. Ltd. / 1061 / Clarification Letter
Sentiss Pharma Pvt. Ltd. / 1688 / Clarification Letter

LETTER PERTAINING TO REGISRATION

S.no. / Name of applicant / Diary no. / Type of letter
Sign pharma trade services pvt. Ltd. / 45839 / Approval letter
Bristol-mayer / 49703 / Amended letter
Boehringer ingelheim india pvt. Ltd. / 49630 / Letter
Msc chemicals / 1354 / Clarification letter
Sinopharm india pvt. Ltd. / 37830 / Clarification letter
Chemet / 40689 / Clarification letter
Health ‘n’ u / 42709 / Clarification letter
Shah tc / 43747 / Clarification letter

LETTER PERTAINING TO RULE-37

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
SPARSHA PHARMA / 46011 / APPROVAL LETTER

MEDICAL DEVICE DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. J.Mitra & Bros., New Delhi / 9517 / Clarification Letter
M/s. India Medtronic Pvt. Ltd., New Delhi / 48594 / Clarification Letter
M/s. TTK Healthcare Ltd., Thiruvananthapuram / FTS no. 17135 / Letter
M/s. Regulatory Solutions, Gurgaon / 27589 / Query Letter
M/s. St. Jude Medical India pvt.Ltd., Hyderabad / 41156 / RC
M/s. Fresenius Kabi India pvt. Ltd., Pune / 49326 / RC
M/s. Fresenius Kabi India pvt. Ltd., Pune / 49099 / F-10
M/s. Abbott Healthcare Pvt. Ltd., Mumbai / 37661 / E-RC & E-F-10
M/s. Illusion Dental Laboratory Pvt. Ltd., Mumbai / 47981 / F-10
M/s. Emergo India Pvt. Ltd., Hyderabad / 45088 / RC
M/s. Boston Scientific india Pvt.Ltd., New Delhi / 46387 / RC & F-10
M/s. Admirus Marksol Pvt.Ltd., Panvel / 37056 / RC
M/s. Omni Lens Pvt. Ltd., Gandhi Nagar & FDA Gandhinagar / FTS no. 73239 / Letter
M/s. S.H. Pitkar Orthotools Pvt. Ltd., Pune & FDA Pune / FTS no. 73858 / Letter
M/s. Sigma Surgical Pvt. Ltd., Ahmedabad & FDA Gandhinagar / FTS no. 74494 / Letter
M/s. Harsoris Healthcare, Gurgaon & FDA Haryana / FTS no. 76802 / Letter
M/s. Vascular Concepts Ltd., Bangalore & Drugs Control Department, Bangalore / FTS no. 66087 / Letter

DIAGNOSTICS DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/s. Beckman Coulter India pVt. Ltd., Mumbai / 46437 / F-10
M/s. Alere Medical Pvt. Ltd., Daruhera / 44934 / F-10
M/s. Athenese DX, Chennai / 47130 / E-F-10
M/s. Alere Medical Pvt. Ltd., Daruhera / 51053 / F-10
M/s. Medsource Ozone, New Delhi / 49508 / F-10
M/s. Rapid Diagnostics, Delhi / 49710 / F-10
M/s. Agappe Diagnotics Ltd., Kerela / 47624 / F-10
M/s. Nucleus Inc., Ahmedabad / 49736 / F-10
M/s. Dynamic Tracom, kolkata / 48729 / F-10
M/s. Clinsys Healthcare, Chennai / 50467 / F-10
M/s. Transasia Bio-medicals ltd., Solan / 51225 / Query letter
M/s. Beckman Coulter India pVt. Ltd., Mumbai / 50734 / Query letter
M/s. Biorad Laboratories, Gurgaon / 38385 / Query letter
M/s. Alere Medical Pvt. Ltd., Daruhera / 50401 / Query letter
M/s. Immucor india pvt. Ltd., New Delhi / 48864 / Query letter
M/s. Alixir Medical System, Pune / 50431 / Query letter

GLOBAL CLINICAL TRIAL

Sr. No. / Name of Firm / Reference No. / Type of Letter
1. / M/s. A. menarini / - / Clarification Letter
2. / M/s. Max neeman / 48284 / PA Approval Letter
3. / M/s. MSD / 47294 / Change in CRO Approval letter
4. / M/s. PPD / 50305/49018 / New sites Approval

VACCINE DIVISION

S. No. / COMPANY NAME / Dy. No. / STATUS
1 / M/s Cadila Pharmaceutical Ltd / Invitation letter
2 / M/s Merck Specialites Pvt, Limited / 788 / Approval letter

MEDICAL DEVICE DIVISION

DIAGNOSTICS DIVISION

WRITTEN CONFIRMATION

INTERNATIONAL CELL

S. No / Firm Name / Type of Letter
1. / M/s Fresenius Kabi Oncology , Himachal Pradesh / NOC Certificate
2. / M/s Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat / NOC Certificate

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/s. Intas Pharmaceuticals Ltd. / - / Query Letter
M/s. Glenmark Pharmaceuticals Ltd / - / IND Meeting Letter