LETTERS FOR ISSUE ON 13.05.2015
MEDICAL DEVICE
S.NO. / COMPANY NAME / DIARY NO / STATUSM/S. ZIMMER INDIA PVT LTD.,. / 12123 / APPROVAL LETTER(END-RC)
M/S. ZIMMER INDIA PVT LTD / 12123 / APPROVAL(F-IL)
M/S. GUJARAT ORTHOFIX / 12142 / APPROVAL (F-IL)
M/S. ST JUDE MEDICAL INDIA PVT. LTD., / 6249 / APPROVAL (F-RC)
M/S. ST JUDE MEDICAL INDIA PVT. LTD., / 6249 / APPROVAL (F-IL)
M/S. UMA SURGICALS / 6188 / APPROVAL(F-RC)
M/S. MERIT MEDICAL SYSTEMS INDIA PVT. LTD. / 5499 / APPROVAL(F-RC)
M/S. MERIT MEDICAL SYSTEMS INDIA PVT. LTD. / 5499 / APPROVAL(F-IL)
M/S B.L. LIFESCIENCES PVT. LTD., / 10236 / APPROVAL (F-IL)
M/S SPAN HEALTHCARE PVT LTD., / 7087 / APPROVAL(F-RC)
M/S BIOMET ORTHOPEDIC INDIA PVT. LTD.,, / 4036 / LETTER
M/S EDWARDS LIFESCIENCES(INDIA) PVT LTD., / 8021 / AMENDMENT LETTER
M/S W.L. GORE & ASSOCIATED(PACIFIC) PTE LTD., / 51415,FTS 677 / AMENDMENT LETTER
M/S MERIL ENDO SURGERY PVT. LTD., / 7352 / NOC LETTER
M/S. BAXTER (INDIA) PVT LTD., / 4425 / AMENDMENT LETTER
M/S JOHNSON & JOHNSON LIMITED / NIL / NIL
THE COMMISSIONER, THIRUVANANTHAPURAM (CLAA)
THE DDC (I), CHENNAI (CLAA)
(M/S. TTK HEALTHCARE LTD) / FTS NO.14143 / APPROVAL LETTER
THE COMMISSIONER, GANDHINAGAR (CLAA)
THE DDC (I), AHMADABAD (CLAA)
(M/S. GRIPORTHO SURGICALS PVT. LTD.,) / FTS NO.17912 / APPROVAL LETTER
THE COMMISSIONER, GANDHINAGAR (CLAA)
THE DDC (I), AHMADABAD (CLAA)
(M/S.SHARMA PHARMACEUTICALS PVT LTD) / FTS NO.19171 / APPROVAL LETTER
THE STATE DRUGS CONTROLLER-CUM-LICENSING AUTHORITY, HARYANA (CLAA)
THE DDC (I), GHAZIABAD (CLAA)
(M/S. STERIMED MEDICAL DEVICES) / FTS-22389 / APPROVAL LETTER
M/S BIOTRONIK MEDICAL DEVICES INDIA PVT LTD., / 5794 / APPROVAL(END-IL)
M/S TERUMO INDIA PVT LTD., / 6332 / LETTER
M/S COOK INDIA MEDICAL DEVICES PVT LTD., / 11741 / EXPERT (QL)
DIAGNOSTIC DIVISION
S.NO. / COMPANY NAME / DIARY NO / STATUS1. / M/S. BIO-RAD LABORATORIES (INDIA) PVT. LTD / 7424 / APPROVAL(END-10)
2. / M/S ACCUREX BIOMEDICAL PVT LTD., / 4050 / APPROVAL(END-10)
3. / M/S AVANTOR PERFORMANCE MATERIALS INDIA LTD., / 10737 / APPROVAL(F-10)
4 / M/S SIEMENS LIMITED / 8971 / APPROVAL(F-10)
5. / M/S MHS PHARMACEUTICALS PVT. LTD., / 9267 / APPROVAL(F-10)
6. / M/S ASPEN DIAGNOSTICS PVT LTD., / 3168 / APPROVAL(F-10)
7. / M/S MINDRAY MEDICAL INDIA PRIVATE LIMITED / 6072 / APPROVAL(F-10)
8. / M/S INSTRUMENTATION LABORATORY INDIA PRIVATE LIMITED / 4647 / APPROVAL(F-10)
9. / M/S BECKMAN COULTER INDIA PRIVATE LIMITED / 9324 / APPROVAL (F-10)
10. / M/S SIEMENS LIMITED / 8000 / APPROVAL(F-10)
11 / M/S MERIL DIAGNOSTICS PVT LTD., / 8333 / APPROVAL(F10)
12 / M/S VISHAT DIAGNOSTICS PVT. LTD., / 7841 / APPROVAL(F-10)
13 / M/S CPC DIAGNOSTICS PVT LTD., / 5873 / APPROVAL(F-10)
14 / M/S DHR HOLDING INDIA PVT LTD., / 9549 / APPROVAL(F-10)
15 / M/S IMMUCOR INDIA PVT LTD., / 7670 / APPROVAL(F-10)
16 / M/S KHC HEALTHCARE INDIA PVT LTD., / 9334 / APPROVAL (F-10)
17 / M/S RAPID DIAGNOSTICS PVT LTD., / 8903 / APPROVAL(F-10)
18 / M/S QUALPRO DIAGNOSTICS/ M/S VIOLA DIAGNOSTICS SYSTEM / 9322 / APPROVAL (F-TL)
19 / M/S ARKRAY HEALTHCARE PVT LTD., / 9729 / APPROVAL (F10)
SND DIVISION
S. NO. / NAME OF THE COMPANY / REF. NO. / TYPE OF LETTERM/S. CADILA HEALTHCARE LIMITED., / 9831 / DEFICIENCY LETTER
M/S. VIRCHOW BIOTECH PVT. LTD., / 8216 / DEFICIENCY LETTER
M/S. CLIANTHA RESEARCH LTD., / 5318 / DEFICIENCY LETTER
FDC DIVISION
S.NO. / NAME OF COMPANY / DIARY NO / DOCUMENTM/S. ACME FORMULATIONS PVT. LTD., / 11615 / APPROVAL LETTER
M/S. PFIZER LTD., / 48534 / LETTER
M/S. SANZYME LTD., / 9693 / LETTER
M/S. MEPROMAX LIFESCIENCES / 10823 / LETTER
M/S. AJANTA PHARMA LTD., / 7596 / SITE ADDITION
WRITTEN CONFIRMATION
INTERNATIONAL CELL
S. NO / FIRM NAME / TYPE OF LETTER1. / M/S. RANBAXY LABORATORIES LTD., / WC
2. / M/S. MYLAN LABORATORIES LTD / LETTER
GLOBAL CLINICAL TRIAL
SR. NO. / NAME OF FIRM / REFERENCE NO. / TYPE OF LETTER1. / M/S. ROCHE / 14060 / TL APPROVAL LETTER
2. / M/S. MAYA CLINIALS / 13780 / AMENDMENT IN EXPORT NOC APPROVAL LETTER
3. / M/S. INC RESEARCH / - / NEW SITES APPROVAL LETTER
VACCINE DIVISION
S. NO. / COMPANY NAME / DY. NO. / STATUS1 / M/S INDIAN IMMUNOLOGICAL LTD / 40001 / APPROVAL LETTER
2 / M/S DR. REDDY LABORATORIES LTD / 12285 / CLARIFICATION LETTER
3 / M/S GSK PHARMACEUTICALS LTD / 45629, 12663 / APPROVAL & AMENDMENT LETTER
4 / M/S LG LIFESCIENCES INDIA LTD / 1370 / CLARIFICATION LETTER
5 / M/S RELIANCE LIFESCIENCES PVT, LTD / 543, 12163 / APPROVAL LETTER
6 / M/ROCHE PRODUCTS INDIA PVT, LTD / 535 / APPROVAL LETTER
7 / M/S BIOCON LTD / 48786, / APPROVAL& AMENDMENT LETTER
8 / M/S CADILA HEALTHCARE LTD / 10652, 8831, 10653 / APPROVAL, CONTINUATION & AMENDMENT LETTER
9 / M/S INTAS PHARMCEUTICALS LTD / 10499, 17986, 39322,45440 / APPROVAL & CLARIFICATION LETTER
10 / M/S ELI LILLY AND COMPANY INDIA LTD / 7354 / APPROVAL LETTER
11 / M/S NOVO NORDISK PVT, LTD / CLARIFICATION LETTER
12 / M/S CLIANTHA RESEARCH LTD / CLARIFICATION LETTER
13 / M/S VIRCHOW BIOTECH PVT LTD / 9744 / CLARIFICATION LETTER
14 / M/S SYNGENE INTERNATIONAL LTD / CLARIFICATION LETTER
15 / M/S TORRENT PHARMACEUTICALS LTD / 12762 / CLARIFICATION LETTER
16 / M/S SANOFI PASTEUR INDIA PVT, LTD / CLARIFICATION LETTER
17 / M/S SERUM INSTITUTE OF INDIA LTD / 11119 / CLARIFICATION LETTER
18 / M/S MSD PHARMACEUTICALS PVT, LTD / 9056 / CLARIFICATION LETTER
19 / M/S NOVARTIS HEALTHCARE PVT, LTD / 10038 / CLARIFICATION LETTER
20 / M/S BRISTOL MYERS SQUIBB INDIA PVT, LTD / 6830 / CLARIFICATION LETTER
21 / M/S BOEHRINGER INGELHEIM INDIA PVT, LTD / 103736 / CLARIFICATION LETTER
22 / M/S PAVIOUR PHARMACEUTICALS LTD / CLARIFICATION LETTER
23 / M/S ABBOTT INDIA LTD / CLARIFICATION LETTER
24 / M/S SANDOR MEDICAIDS PVT, LTD / 9351 / CLARIFICATION LETTER
25 / M/S BAXTER INDIA PVT, LTD / CLARIFICATION LETTER