LETTERS FOR ISSUE ON 24.11.2014
LETTER PERTAINING TO REGISTRATION
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / RAJ NAKRA ASSOCIATES / 42065 / APPROVAL LETTER
2. / GSK PHARMACEUTICALS LTD. / 33702 / CLARIFICATION LETTER
3. / FRIENDS MEDICOS / 30682 / CLARIFICATION LETTER
LETTER PERTAINING TO RULE-37
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / BIDDLE SAWYER LTD. / 43891 / APPROVAL LETTER
GLOBAL CLINICAL TRIAL
Sr. No. / Name of Firm / Reference No. / Type of Letter1. / M/s. Pfizer / 42905 / Amendment in TL
2. / M/s. Covance / 37838 / TL Approval
3. / M/s. Amgen / 40686 / Change in PI Approval
4. / Ms. Eli Lilly / 52427 / CT NOC Approval letter
SUBSEQUENT NEW DRUG
S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER1. / M/s CadilaPharmaceuticals Ltd., / 23635 / - / Approval Letter
2. / M/s Allergan India Pvt. Ltd. / 55539 / 76464 / Query Letter
3. / M/s Abbott Healthcare Pvt. Ltd., / 33395 / 18107 / Query Letter
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT1. / M/s. Troikaa Pharmaceuticals / 24577 / Approval Letter
2. / M/s. Ajanta Pharma / 15122 / Approval Letter
3. / M/s. Ajanta Pharma / 23627 / Approval Letter
4. / M/s. Zim Laboratories / 25222 / Approval Letter
5. / M/s. ESPI Industries & Chemicals Pvt. Ltd., / 41824 / Letter
6. / M/s. Bescoat / 58338 / Letter
7. / M/s. Pfizer Ltd., / NIL / SEC Meeting Letter
8. / M/s. Biocon Ltd., / NIL / SEC Meeting Letter
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Terumo Penopal Limited. / 24338 / Approval (F-RC)
2. / M/s. Terumo Penopal Limited. / 24338 / Approval (F-IL)
3. / M/s. St. Jude Medical India Pvt. Ltd. / 38005 / Approval (R-E-RC)
4. / M/s. St. Jude Medical India Pvt. Ltd. / 38005 / Approval (R-E-IL)
5. / M/s. Browndove Healthcare Pvt. Ltd. / 39759 / Approval (F-IL)
6. / M/s. Johnson & Johnson Ltd. / 18326 / Approval (F-IL)
7. / M/s. Smith & Nephew Pvt. Ltd. / 39365 / Approval (F-IL)
8. / M/s. Venous Remedies Ltd. / FTS-57960 / Approval (F-IL)
9. / M/s. Browndove Healthcare Pvt. Ltd. / 39759 / Approval Letter
10. / M/s. Covidien Healthcare Pvt. Ltd. / 40847 / Approval Letter
11. / M/s. Johnson & Johnson Ltd. / 35759 / Approval Letter
12. / M/s. Johnson & Johnson Ltd. / 43215 / Letter
13. / M/s. St. Jude Medical India Pvt. Ltd. / 35218 / Letter
14. / M/s. Bard India Healthcare Pvt. Ltd. / 42253 / Letter
15. / M/s. Genius Ortho Pvt. Ltd. (CLAA) / FTS-45951 / Letter
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/s. Aura Medical Devices Ltd.
All port offices of CDSCO. / 33594 / Approval (IL)
2. / M/s. Siemens Limited.
All Port offices of CDSCO. / 32756 / Approval (IL)
3. / M/s. Vishat Diagnostics Pvt. Ltd.
All port offices of CDSCO. / 38501 / Approval (IL)
4. / M/s. Becton Dickinson India Pvt. Ltd.
All port offices of CDSCO. / 38988 / Approval (E-IL)
5. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd.
All port offices of CDSCO. / 37825 / Approval (E-IL)
6. / M/s. Bio-Rad Laboratories (India) Pvt. Ltd.
All port offices of CDSCO. / 36593 / Approval (E-IL)
7. / M/s. Beckman Coulter India Pvt. Ltd.
All port offices of CDSCO. / 38408 / Approval (TL)
8. / M/s. OSB Agencies Pvt. Ltd.
All port offices of CDSCO. / 37427 / Approval (TL)
9. / M/s. Trivitron Healthcare Pvt. Ltd.
All port offices of CDSCO. / 38925 / Approval (TL)
10. / M/s. Instrumentation Laboratory India Pvt. Ltd.
All port offices of CDSCO. / 38164 / Approval Letter
Vaccine Division
S. No. / COMPANY NAME / Dy. No. / STATUS1 / M/s M.J. Biopharma Pvt. Ltd. / 35993, 40968 / Clarification letter
2 / M/s Biological E. Ltd. / 36873 / Clarification letter
3 / M/s Cadila Healthcare Ltd / 62020(fts), 60376(fts), 58059(fts), 58057(Fts), 58056(fts), / Approval Letter
4 / M/s VHB LifeSciences ltd / 38506 / Approval Letter
NEW DRUG
S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER1. / Dr. Willmar Schwabe India Pvt Ltd. / - / Query Letter
2. / Dr. Dinesh Kumar / - / Query Letter