Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1Axplora
03 1Sanofi
04 1Aarti Drugs
05 1Aurobindo Pharma Limited
06 1Boehringer Ingelheim GmbH
07 1Cadila Pharmaceuticals
08 1Cambrex Corporation
09 1Centaur Pharmaceuticals
10 1Cipla
11 1Divis Laboratories
12 1Gador SA
13 2Glenmark Life Sciences
14 2Lunan Pharmaceutical
15 1Lupin Ltd
16 1Orchid Pharma
17 1Quimica Sintetica
18 1RANBAXY LABORATORIES LIMITED
19 1SYNTHON Chemicals GmbH & Co. KG
20 1Sun Pharmaceutical Industries Limited
21 1Synthelabo Tanabe Chimie
22 2TAPI Technology & API Services
23 1Torrent Pharmaceuticals Limited
24 1UQUIFA
25 1Unichem Laboratories Limited
26 1Viatris
27 1Wockhardt
28 1YUNG ZIP CHEMICAL INDUSTRIAL
29 1Zentiva
30 1Zydus Lifesciences
31 1Blank
01 1ZOLPIDEM HEMITARTRATE
02 18ZOLPIDEM TARTRATE
03 1ZOLPIDEM TARTRATE (NON-STERILE BULK FORM)
04 1ZOLPIDEM TARTRATE BP/PH.EUR.
05 1ZOLPIDEM TARTRATE DRUG SUBSTANCE
06 1ZOLPIDEM TARTRATE MODIFIED SYNTHESIS
07 11ZOLPIDEM TARTRATE USP
01 1Argentina
02 2China
03 2Czech Republic
04 2France
05 3Germany
06 16India
07 2Israel
08 2Spain
09 1Taiwan
10 2U.S.A
11 1Blank
01 18Active
02 16Inactive
01 8Complete
02 26Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-11
Pay. Date : 2019-04-05
DMF Number : 15486
Submission : 2001-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11764
Submission : 1995-12-05
Status : Inactive
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20984
Submission : 2007-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-19
Pay. Date : 2014-03-07
DMF Number : 18974
Submission : 2005-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17098
Submission : 2003-12-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-04
DMF Number : 18164
Submission : 2005-03-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18430
Submission : 2005-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17712
Submission : 2004-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-13
DMF Number : 15958
Submission : 2002-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18221
Submission : 2005-03-30
Status : Active
Type : II
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