01 1SIGMA TAU
01 16-AMINONICOTINAMIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3714
Submission : 1980-01-30
Status : Inactive
Type : II
A 6-Aminonicotinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 6-Aminonicotinamide, including repackagers and relabelers. The FDA regulates 6-Aminonicotinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 6-Aminonicotinamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 6-Aminonicotinamide supplier is an individual or a company that provides 6-Aminonicotinamide active pharmaceutical ingredient (API) or 6-Aminonicotinamide finished formulations upon request. The 6-Aminonicotinamide suppliers may include 6-Aminonicotinamide API manufacturers, exporters, distributors and traders.
click here to find a list of 6-Aminonicotinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 6-Aminonicotinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 6-Aminonicotinamide active pharmaceutical ingredient (API) in detail. Different forms of 6-Aminonicotinamide DMFs exist exist since differing nations have different regulations, such as 6-Aminonicotinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 6-Aminonicotinamide DMF submitted to regulatory agencies in the US is known as a USDMF. 6-Aminonicotinamide USDMF includes data on 6-Aminonicotinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 6-Aminonicotinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 6-Aminonicotinamide suppliers with USDMF on PharmaCompass.
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