01 1Curia
02 2Viatris
03 1Vintage Pharmaceuticals-Charlotte
01 3MAFENIDE ACETATE USP
02 1SULFAMYLON (MAFENIDE) ACETATE
01 4U.S.A
01 4Active
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12419
Submission : 1997-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32292
Submission : 2017-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-12-19
DMF Number : 24615
Submission : 2011-05-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24722
Submission : 2011-03-08
Status : Active
Type : II
A Mafenide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mafenide, including repackagers and relabelers. The FDA regulates Mafenide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mafenide 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 Mafenide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mafenide supplier is an individual or a company that provides Mafenide active pharmaceutical ingredient (API) or Mafenide finished formulations upon request. The Mafenide suppliers may include Mafenide API manufacturers, exporters, distributors and traders.
click here to find a list of Mafenide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mafenide DMF (Drug Master File) is a document detailing the whole manufacturing process of Mafenide active pharmaceutical ingredient (API) in detail. Different forms of Mafenide DMFs exist exist since differing nations have different regulations, such as Mafenide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mafenide DMF submitted to regulatory agencies in the US is known as a USDMF. Mafenide USDMF includes data on Mafenide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mafenide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mafenide suppliers with USDMF on PharmaCompass.
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