01 1SAFC
01 12,5-DIHYDROXYBENZOIC ACID
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10577
Submission : 1993-11-08
Status : Inactive
Type : II
A Gentisic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentisic Acid, including repackagers and relabelers. The FDA regulates Gentisic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentisic Acid 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 Gentisic Acid supplier is an individual or a company that provides Gentisic Acid active pharmaceutical ingredient (API) or Gentisic Acid finished formulations upon request. The Gentisic Acid suppliers may include Gentisic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Gentisic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentisic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Gentisic Acid active pharmaceutical ingredient (API) in detail. Different forms of Gentisic Acid DMFs exist exist since differing nations have different regulations, such as Gentisic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gentisic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Gentisic Acid USDMF includes data on Gentisic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gentisic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gentisic Acid suppliers with USDMF on PharmaCompass.
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