LETTERS FOR ISSUE ON 18.05.2015

GLOBAL CLINICAL TRIAL

SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER
1. / M/S. NOVARTIS / - / CLARIFICATION LETTER
2. / M/S. PAREXEL / 12894 / CLARIFICATION LETTER
3. / M/S. SANOFI PASTEUR / 8716 / CLARIFICATION LETTER

WRITTEN CONFIRMATION

INTERNATIONAL CELL

S. NO / FIRM NAME / TYPE OF LETTER
1. / M/S. LUPIN LTD., M.P. / WC

SUBSEQUENT NEW DRUG

S. NO. / NAME OF THE FIRM / REFERENCE NO. / FTS NO. / TYPE OF LETTER
M/S SUN PHARMACEUTICALS INDUSTRIES LIMITED., / 47935 / - / PERMISSIONLETTER

FDC DIVISION

S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENT
M/S. SUN PHARMACEUTICALS INDUSTRIES LTD., / 9723 & 12004 / SITE ADDITION

GLOBAL CLINICAL TRIAL

SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER
1. / M/S. PPD / 10497 / PA APPROVAL LETTER
2. / M/S. MSD / 10896 / CHANGE IN PI APPROVAL LETTER
3. / M/S. BOEHRINGER / 10222 / NEW SITES APPROVAL LETTER
4. / M/S. JOHNSON / - / SEC MINUTES OF MEETING

MEDICAL DEVICE

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. / 49240 / APPROVAL (F-RC)
M/S. JOHNSON & JOHNSON LTD. / 51332 / APPROVAL (F-RC)
M/S. JOHNSON & JOHNSON LTD. / 51332 / APPROVAL (F-IL)
M/S. INNOVATIVE THERAPEUTICS (P) LTD. / 4622 / APPROVAL (F-RC)
M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. / 3239 / APPROVAL (E-RC)
M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. / 3239 / APPROVAL (E-IL)
M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. / 46385 / APPROVAL (R-E-RC)
M/S. BOSTON SCIENTIFIC INDIA PVT. LTD. / 46385 / APPROVAL (R-E-IL)
M/S. ZIMMER INDIA PVT. LTD. / 3008 / APPROVAL (R-E-RC)
M/S. ZIMMER INDIA PVT. LTD. / 3008 / APPROVAL (R-E-IL)
M/S. SERUM INSTITUTE OF INDIA LTD. / 7968 / APPROVAL (F-IL)
M/S. REGULATORY SOLUTIONS INDIA. / 8981 / CLARIFICATION LETTER
M/S. SHREE PACETRONIX LTD. / FTS-14623 / CLARIFICATION LETTER
M/S. BEST HEARING SOLUTIONS. / NIL / LETTER
DR. V.G. MOHAN PRASAD, TAMILNADU. / NIL / CLARIFICATION LETTER
M/S. DELHI HOSPITAL SUPPLY PVT. LTD. / 8915 / QUERY LETTER
M/S. MEDIHAUXE INTERNATIONAL. / NIL / LETTER
M/S. URMEE HEALTHCARE. / 986 / QUERY LETTER
M/S. TRANSLUMINA THERAPEUTICS (CLAA) / FTS-66196 / LETTER
M/S. ENVISION SCIENTIFIC PVT. LTD.(CLAA) / FTS-69378 / LETTER

DIAGNOSTIC DIVISION

S.NO. / COMPANY NAME / DIARY NO / STATUS
M/S. ABBOTT HEALTHCARE PVT. LTD. / 7546 / APPROVAL (E-RC)
M/S. ABBOTT HEALTHCARE PVT. LTD. / 7546 / APPROVAL (E-IL)
M/S. BOSTON IVY HEALTHCARE SOLUTIONS PVT. LTD. / 7482 / APPROVAL (IL)
M/S. DIAGNOSTIC SYSTEM. / 5624 / APPROVAL (IL)
M/S. IRIS HEALTHCARE TECHNOLOGIES PVT. LTD. / 7248 / APPROVAL (IL)
M/S. INDIA MEDTRONIC PVT. LTD. / 6862 / APPROVAL (IL)
M/S. INDIA MEDTRONIC PVT. LTD. / 6862 / QUERY LETTER
M/S. JOHNSON & JOHNSON LTD. / 6355 / APPROVAL (IL)
M/S. BECKMAN COULTER INDIA PVT. LTD. / 6068 / APPROVAL (E-IL)
THE DIRECTOR, HARYANA
MR. S.K. DUTTA, NEW DELHI. / NIL / QUERY LETTER

VACCINE DIVISION

S. NO. / COMPANY NAME / DY. NO. / STATUS
1 / M/S NIRLAC CHEMICALS / 12956 / CLARIFICATION LETTER
2 / M/S INTERVET INDIA PVT, LTD / 1592 / APPROVAL LETTER
3 / M/S ROCHE PRODUCTS INDIA PVT, LTD / 7428, 14462 / APPROVAL & CLARIFICATION LETTER
4 / M/S GSK PHARMACEUTICALS LTD / 14120, 9904 / APPROVAL & CLARIFICATION LETTER
5 / M/S WOCKHARDT LTD / CLARIFICATION LETTER
6 / M/S SANOFI PASTEUR INDIA PVT LTD / 12562, 1542 / AMENDMENT & CLARIFICATION LETTER
7 / M/S SYMBIO GENERRIES INDIA PVT, LTD / 34010 / CLARIFICATION LETTER
8 / M/S ZOETIS INDIA LTD / 5743 / CLARIFICATION LETTER
9 / M/S MSD PHARMACEUTICALS PVT, LTD / 11271 / CLARIFICATION LETTER
10 / M/S WYETH LTD / 6986 / AMENDMENT LETTER
11 / M/S NOVATIS HEALTHCARE PVT, LTD / CLARIFICATION LETTER
12 / M/S VETERINARY BIOLOGICALS AND RESEARCH INSTITUTE / 71469 (FTS NO) / APPROVAL LETTER
13 / M/S EL-SHADDAI BIOLOGICALS LTD / APPROVAL LETTER
14 / M/S FULFORD INDIA LTD / 10314 / CLARIFICATION LETTER
15 / M/S ESSCHEM PVT, LTD / 10083 / CLARIFICATION LETTER
16 / M/S RELIANCE LIFE SCIENCES PVT, LTD / 7728 / APPROVAL LETTER
17 / M/S INTAS PHARMACEUTICALS LTD / CLARIFICATION LETTER
18 / M/S HEMOPHILIA FEDRATION (INDIA) / 14614 FTS / APPROVAL LETTER

NEW DRUG

S.NO. / NAME OF APPLICANT / DIARY NO. / TYPE OF LETTER
M/S. GLENMARK PHARMACEUTICALS / - / LETTER
M/S. ASTRAZENECA PHARMA INDIA LTD / - / QUERY LETTER
M/S HETERO LABS LIMITED / - / IPC LETTER
M/S NOVARTIS HEALTHCARE PVT LTD / - / QUERY LETTER
M/S MYLAN PHARMACEUTICALS PVT LTD / - / QUERY LETTER
M/S PFIZER LTD / - / MEETING NOTICE 29-05-2015 (ANALGESIC & RHEUMATOLOGY)
M/S VIRCHOW BIOTECH PVT LTD / - / MEETING NOTICE 29-05-2015 (ANALGESIC & RHEUMATOLOGY)
M/S AJANTA PHARMA / - / MEETING NOTICE 29-05-2015 (ANALGESIC & RHEUMATOLOGY)