Letters for Issue On15.09.2014

LETTERS FOR ISSUE ON15.09.2014

LVP DIVISION

S. NO. / COMPANY NAME / FTS NO. /Diary No. / STATUS
01 / M/s. Denis Chem Lab, Gujarat / 51359 / Approval
02 / M/s. Tablets India Ltd., Chennai / 50872 / Approval

VACCINE DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Sanofi Pasteur India Pvt, Ltd / Clarification Letter
2 / M/s Roche Products Pvt, ltd / 5118, 29159 / Clarification Letter
3 / M/s Stemade Biotech Pvt, Ltd / Clarification Letter
4 / M/s Eli Lilly and company india pvt, ltd / 32554 / Clarification Letter
5 / M/s Pfizer Products (India) Pvt, ltd / 39859 / Clarification Letter
6 / M/s Cadila Pharmaceutical Ltd / Clarification Letter
7 / M/s Accutest Research Laboratories (I) pvt, Ltd / 20049 / Clarification Letter
8 / M/s Cadila Healthcare Ltd / 26344 / Approval Letter & Clarification Letter
9 / M/s HLL Biotech Limited / 37454, 37453 / Invitation letter

BIOLOGICAL DIVISION

S. No. / COMPANY NAME / Dy.No. / STATUS
1 / M/s Shantha Biotechnices Pvt, Ltd / 35816,35818 / Approval Letter
2 / M/s Globion India Pvt,, Ltd / 33948 / Approval Letter
3 / M/s Serum Institute of India Pvt , ltd / 36231 / Approval Letter
4 / M/s Nektar Therapeutics India Pvt, Ltd / 35819 / Approval Letter
5 / M/s National Diary Development Board / 52788 (fts no) / Approval Letter

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/s. Windlas Biotech / 44021 / Letter
M/s. Twenty First Centuary Pharmaceuticals / 42283 / Letter
M/s. Verizon Genesis Pvt. Ltd., / 5522 / Letter
M/s. INNOVA CapTab / 30130 / Letter
M/s. Dr. Reddy;s Laboratories Ltd., / 31566 / Letter
M/s. Cipla Limited / 41301 / Clarification Letter
M/s. Torrent Pharmaceuticals Pvt. Ltd., / 25126/30718 / Letter

IMPORT

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
ASTELLAS PHARMA INDIA PVT. LTD / 24799 / CLARIFICATION LETTER
BRISTOL MYERS SQUIBB INDIA PVT. LTD. / 27862,28072 / 2 CLARIFICATION LETTER
DR. REDDY’S LABORATORIES LTD. / 29051 / CLARIFICATION LETTER
BIOCON LTD. / 37427 / CLARIFICATION LETTER
JOHNSON & JOHNSON LTD. / 65377 / CLARIFICATION LETTER
BOEHRINGER INGELHEIM INDIA PVT. LTD. / 48291 / CLARIFICATION LETTER
FULFORD(INDIA) LTD. / 33731 / CLARIFICATION LETTER
NOVARTIS INDIA LTD. / 39906,35535 / 2 CLARIFICATION LETTER
ORGANON INDIA PVT LTD. / 35118 / CLARIFICATION LETTER
BIOGEN IDEC BIOTECH INDIA PVT. LTD. / 36209 / CLARIFICATION LETTER

REGISTRATION

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
BIOCON LTD. / 33484 / AMENDED LETTER
JOHNSON & JOHNSON LTD. / 21607 / CLARIFICATION LETTER
INTAS PHARMACEUTICALS LTD. / 26916 / CLARIFICATION LETTER
GLAXOSMITHKLINE PHARMACEUTICALS LTD. / 22119 / CLARIFICATION LETTER
ETHACHEM / 19487 / CLARIFICATION LETTER
NOVARTIS INDIA LTD. / 25676 / CLARIFICATION LETTER
UNIPHARMA / 28732 / CLARIFICATION LETTER
LUNDBECK INDIA PVT. LTD. / 22935 / CLARIFICATION LETTER
SANOFI SYNTHELABO INDIA LTD. / 18969,22785 / 2 CLARIFICATION LETTER
SHAH TC OVERSEASE PVT. LTD / 20189 / CLARIFICATION LETTER
ASTRAZENECA PHARMA INDIA LTD. / 22991 / CLARIFICATION LETTER

SHELF LIFE/MISC.

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
ADORA PRODCUTS PVT. LTD. / 35545, 35544 / 2 APPROVAL LETTER
CREDENCE REMEDIES PVT. LTD. / 33082,33083, / 2 APPROVAL LETTER
SOCIAL ACTION AND VALUE EDUCATION TRUST / NIL / CLARIFICATION LETTER