Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1Axplora
03 1Sanofi
04 2TAPI Technology & API Services
05 1Aarti Drugs
06 1Aurobindo Pharma Limited
07 1Boehringer Ingelheim GmbH
08 1Cadila Pharmaceuticals
09 1Cambrex Corporation
10 1Centaur Pharmaceuticals
11 1Cipla
12 1Divis Laboratories
13 1Gador SA
14 2Glenmark Life Sciences
15 2Lunan Pharmaceutical
16 1Lupin Ltd
17 1Orchid Pharma
18 1Quimica Sintetica
19 1RANBAXY LABORATORIES LIMITED
20 1SYNTHON Chemicals GmbH & Co. KG
21 1Sun Pharmaceutical Industries Limited
22 1Synthelabo Tanabe Chimie
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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18982
Submission : 2005-11-28
Status : Inactive
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 18221
Submission : 2005-03-30
Status : Active
Type : II
A Zolpidem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zolpidem, including repackagers and relabelers. The FDA regulates Zolpidem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zolpidem API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Zolpidem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zolpidem supplier is an individual or a company that provides Zolpidem active pharmaceutical ingredient (API) or Zolpidem finished formulations upon request. The Zolpidem suppliers may include Zolpidem API manufacturers, exporters, distributors and traders.
click here to find a list of Zolpidem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zolpidem DMF (Drug Master File) is a document detailing the whole manufacturing process of Zolpidem active pharmaceutical ingredient (API) in detail. Different forms of Zolpidem DMFs exist exist since differing nations have different regulations, such as Zolpidem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zolpidem DMF submitted to regulatory agencies in the US is known as a USDMF. Zolpidem USDMF includes data on Zolpidem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zolpidem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zolpidem suppliers with USDMF on PharmaCompass.
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