01 1Cambrex Corporation
02 1Centaur Pharmaceuticals
03 1F.I.S. Fabbrica Italiana Sintetici
04 1R L Fine Chem
05 1Sandoz B2B
06 1Viatris
07 1Wyeth Pharmaceuticals Inc
08 1Blank
01 6TEMAZEPAM
02 2TEMAZEPAM USP
01 2India
02 1Italy
03 1Switzerland
04 3U.S.A
05 1Blank
01 4Active
02 4Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-16
DMF Number : 4376
Submission : 1981-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25364
Submission : 2011-10-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-12-18
DMF Number : 5223
Submission : 1983-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38998
Submission : 2023-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5507
Submission : 1984-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23160
Submission : 2009-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3193
Submission : 1978-04-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6162
Submission : 1986-01-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Temazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temazepam, including repackagers and relabelers. The FDA regulates Temazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temazepam 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 Temazepam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temazepam supplier is an individual or a company that provides Temazepam active pharmaceutical ingredient (API) or Temazepam finished formulations upon request. The Temazepam suppliers may include Temazepam API manufacturers, exporters, distributors and traders.
click here to find a list of Temazepam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Temazepam DMF (Drug Master File) is a document detailing the whole manufacturing process of Temazepam active pharmaceutical ingredient (API) in detail. Different forms of Temazepam DMFs exist exist since differing nations have different regulations, such as Temazepam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Temazepam DMF submitted to regulatory agencies in the US is known as a USDMF. Temazepam USDMF includes data on Temazepam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temazepam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Temazepam suppliers with USDMF on PharmaCompass.
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