01 1Pfizer Inc
01 1N-ACETYLPROCAINAMIDE HCL.
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6186
Submission : 1986-01-29
Status : Inactive
Type : II
A Acecainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acecainide, including repackagers and relabelers. The FDA regulates Acecainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acecainide 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 Acecainide supplier is an individual or a company that provides Acecainide active pharmaceutical ingredient (API) or Acecainide finished formulations upon request. The Acecainide suppliers may include Acecainide API manufacturers, exporters, distributors and traders.
click here to find a list of Acecainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acecainide DMF (Drug Master File) is a document detailing the whole manufacturing process of Acecainide active pharmaceutical ingredient (API) in detail. Different forms of Acecainide DMFs exist exist since differing nations have different regulations, such as Acecainide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acecainide DMF submitted to regulatory agencies in the US is known as a USDMF. Acecainide USDMF includes data on Acecainide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acecainide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acecainide suppliers with USDMF on PharmaCompass.
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