01 1SAFC
01 1ISOBUTYRAMIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10226
Submission : 1993-04-23
Status : Inactive
Type : II
A Isobutyramide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isobutyramide, including repackagers and relabelers. The FDA regulates Isobutyramide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isobutyramide 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 Isobutyramide supplier is an individual or a company that provides Isobutyramide active pharmaceutical ingredient (API) or Isobutyramide finished formulations upon request. The Isobutyramide suppliers may include Isobutyramide API manufacturers, exporters, distributors and traders.
click here to find a list of Isobutyramide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isobutyramide DMF (Drug Master File) is a document detailing the whole manufacturing process of Isobutyramide active pharmaceutical ingredient (API) in detail. Different forms of Isobutyramide DMFs exist exist since differing nations have different regulations, such as Isobutyramide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isobutyramide DMF submitted to regulatory agencies in the US is known as a USDMF. Isobutyramide USDMF includes data on Isobutyramide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isobutyramide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isobutyramide suppliers with USDMF on PharmaCompass.
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