01 1Arch Pharmalabs
02 2Aurobindo Pharma Limited
03 1Cipla
04 1ERREDUE S.P.A. IT 24040 Isso
05 1Hetero Drugs
06 1RANBAXY LABORATORIES LIMITED
07 1SEQUENT SCIENTIFIC LTD
08 1SIBRA PHARMACEUTICALS LTD
09 1ST Pharma
10 1Shanghai Desano Bio-Pharmaceutical
11 3Viatris
01 3STAVUDINE
02 1STAVUDINE DRUG SUBSTANCE
03 8STAVUDINE USP
04 1STAVUDINE USP (NON-STERILE DRUG SUBSTANCE)
05 1STAVUDINE USP (STR)
01 1China
02 8India
03 1Italy
04 1South Korea
05 3U.S.A
01 5Active
02 9Inactive
01 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17968
Submission : 2004-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19837
Submission : 2006-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17646
Submission : 2004-08-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19863
Submission : 2006-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17997
Submission : 2005-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20087
Submission : 2006-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21279
Submission : 2008-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20423
Submission : 2007-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20107
Submission : 2007-01-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17976
Submission : 2004-01-06
Status : Inactive
Type : II
A Stavudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stavudine, including repackagers and relabelers. The FDA regulates Stavudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stavudine 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 Stavudine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Stavudine supplier is an individual or a company that provides Stavudine active pharmaceutical ingredient (API) or Stavudine finished formulations upon request. The Stavudine suppliers may include Stavudine API manufacturers, exporters, distributors and traders.
click here to find a list of Stavudine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Stavudine DMF (Drug Master File) is a document detailing the whole manufacturing process of Stavudine active pharmaceutical ingredient (API) in detail. Different forms of Stavudine DMFs exist exist since differing nations have different regulations, such as Stavudine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Stavudine DMF submitted to regulatory agencies in the US is known as a USDMF. Stavudine USDMF includes data on Stavudine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stavudine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Stavudine suppliers with USDMF on PharmaCompass.
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