01 1ANDRULIS PHARMACEUTICALS CORP
02 1Hetero Drugs
03 1Laurus Labs
04 1Olon S.p.A
05 1PEDIATRIC PHARMACEUTICALS INC
06 1PHF SA
07 1Sifavitor srl
08 1Viatris
01 4THALIDOMIDE
02 1THALIDOMIDE TABLETS
03 3THALIDOMIDE USP
01 2India
02 2Italy
03 1Switzerland
04 3U.S.A
01 4Active
02 4Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8263
Submission : 1989-10-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-12-06
DMF Number : 19745
Submission : 2006-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-02-19
DMF Number : 27967
Submission : 2014-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18448
Submission : 2005-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9768
Submission : 1992-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-26
Pay. Date : 2015-02-17
DMF Number : 21806
Submission : 2008-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15291
Submission : 2001-02-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29452
Submission : 2015-06-30
Status : Inactive
Type : II
A Thalidomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thalidomide, including repackagers and relabelers. The FDA regulates Thalidomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thalidomide 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 Thalidomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thalidomide supplier is an individual or a company that provides Thalidomide active pharmaceutical ingredient (API) or Thalidomide finished formulations upon request. The Thalidomide suppliers may include Thalidomide API manufacturers, exporters, distributors and traders.
click here to find a list of Thalidomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thalidomide DMF (Drug Master File) is a document detailing the whole manufacturing process of Thalidomide active pharmaceutical ingredient (API) in detail. Different forms of Thalidomide DMFs exist exist since differing nations have different regulations, such as Thalidomide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thalidomide DMF submitted to regulatory agencies in the US is known as a USDMF. Thalidomide USDMF includes data on Thalidomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thalidomide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thalidomide suppliers with USDMF on PharmaCompass.
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