LETTERS FOR ISSUE ON 22.04.2015

VACCINE DIVISION

S. NO. / COMPANY NAME / DY. NO. / STATUS
1 / M/S LUPIN LTD / 13385 (FTS NO) / APPROVAL LETTER
2 / M/S M.J. BIOPHARMA PVT, LTD / 13385 (FTS NO) / APPROVAL LETTER
3 / M/S RELIANCE LIFE SCIENCES PVT, LTD / 16998, 17003, 17001, 16996 (FTS NO) / APPROVAL LETTER

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/S BMS / - / - / SEC LETTER

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/S GLENMARK PHARMACEUTICAL / - / MEETING NOTICE 28.04.2015 (ENDOCRINOLOGY)
M/S. INTAS / - / MEETING NOTICE 28.04.2015 (ENDOCRINOLOGY)
M/S ASTELLAS PHARMA INDIA PVT. / - / MEETING NOTICE 29.04.2015 (REPRODUCTIVE & UROLOGY)
M/S PRECISE CHEMIPHARMA PVT LTD / - / QUERY LETTER

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/S. J. B. CHEMICALS / NIL / SEC LETTER
M/S. FRESENIUS MEDICAL CARE / NIL / SEC LETTER

GLOBAL CLINICAL TRIAL

SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER
1. / M/S. MAYA CLINICALS / - / MINUTES OF SEC

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/S. ADVANCE MEDI - SURG PVT. LTD. / 11465 / APPROVAL (F-RC)
M/S. ADVANCE MEDI - SURG PVT. LTD. / 11466 / APPROVAL (F-IL)
M/S. BIO IMPLANTS INDIA PVT. LTD. / 7262 / APPROVAL (F-IL)
M/S. ONCOCARE SCIENTIFICS PVT. LTD. / 8496 / APPROVAL (R-IL)
M/S. POLY MEDICURE LTD. / 31588 / APPROVAL LETTER
M/S. POLY MEDICURE LTD. / 31589 / APPROVAL LETTER
M/S. POLY MEDICURE LTD. / 31590 / APPROVAL LETTER
M/S. POLY MEDICURE LTD. / 49128 / APPROVAL LETTER
M/S. POLY MEDICURE LTD. / 49129 / APPROVAL LETTER
M/S. BIO-MED HEALTHCARE PRODUCTS PVT. LTD. / 5641 / APPROVAL LETTER
M/S. B. BRAUN MEDICAL (INDIA) PVT. LTD. / 6047 / QUERY LETTER
M/S. B. BRAUN MEDICAL (INDIA) PVT. LTD. / 2185 / LETTER
M/S. ST. JUDE MEDICAL INDIA PVT. LTD. / 5806 / QUERY LETTER
M/S. SHREYAAS HEALTHCARE. / 3301 / QUERY LETTER
M/S. SHREYAAS HEALTHCARE. / 4431 / QUERY LETTER
M/S. CLARIRVOYANCE CONSULTING. / 11005 / LETTER
M/S. ST. JUDE MEDICAL INDIA PVT. LTD. / 7909 / LETTER
M/S. COLOPLAST (INDIA) PVT. LTD. / 6795 / LETTER
M/S. REGULATORY SOLUTIONS INDIA. / 8981 / LETTER

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/S. BIO-RAD LABORATORIES (INDIA) PVT. LTD. / 50887 / APPROVAL (E-R-RC)
M/S. BIO-RAD LABORATORIES (INDIA) PVT. LTD. / 50887 / APPROVAL (E-R-IL)
M/S. ASPEN DIAGNOSTICS PVT. LTD. / 6343 / APPROVAL (IL)
M/S. BEACON DIAGNOSTICS PVT. LTD. / 5560 / APPROVAL (IL)
M/S. DR. REDDYS LABORATORIES LTD. / 6071 / APPROVAL (IL)
M/S. LABX. / 6075 / APPROVAL (IL)
M/S. NIHON KOHDEN INDIA PVT. LTD. / 5403 / APPROVAL (IL)
M/S. RAPID DIAGNOSTIC PVT. LTD. / 4263 / APPROVAL (IL)
M/S. SIRUSBIOCARE PVT. LTD. / 6338 / APPROVAL (IL)
M/S. SIEMENS LTD. / 5185 / APPROVAL (IL)
M/S. SIEMENS LTD. / 5183 / APPROVAL (IL)
M/S. SIEMENS LTD. / 4097 / APPROVAL (IL)
M/S. TRANSASIA BIO MEDICALS LTD. / 4866 / APPROVAL (IL)
M/S. BECKMAN COULTER INDIA PVT. LTD. / 6247 / APPROVAL (IL)
M/S. EURO DIAGNOSTICS SYSTEMS PVT. LTD. / 5810 / APPROVAL (IL)
M/S. LABX. / 3350 / APPROVAL (E-IL)
M/S. SIEMENS LTD. / 3762 / APPROVAL (E-IL)
M/S. MICROGENE DIAGNOSTIC SYSTEM PVT. LTD. / 4923 / APPROVAL (TL)
M/S. SIEMENS LTD. / 50981 / APPROVAL LETTER
M/S. AGAPPE DIAGNOSTICS (P) LTD. / 3726 / QUERY LETTER
M/S. CPC DIAGNOSTICS PVT. LTD. / 5873 / QUERY LETTER
M/S. INSTRUMENTATION LABORATORY INDIA PVT. LTD. / 4647 / QUERY LETTER
M/S. LABINDIA HEALTHCARE PVT. LTD. / 5841 / QUERY LETTER