01 1Muby Chem
01 1PROPIONIC ACID USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43065
Submission : 2025-12-30
Status : Active
Type : IV
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A C2H5COOH manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C2H5COOH, including repackagers and relabelers. The FDA regulates C2H5COOH manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C2H5COOH 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 C2H5COOH manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A C2H5COOH supplier is an individual or a company that provides C2H5COOH active pharmaceutical ingredient (API) or C2H5COOH finished formulations upon request. The C2H5COOH suppliers may include C2H5COOH API manufacturers, exporters, distributors and traders.
click here to find a list of C2H5COOH suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A C2H5COOH DMF (Drug Master File) is a document detailing the whole manufacturing process of C2H5COOH active pharmaceutical ingredient (API) in detail. Different forms of C2H5COOH DMFs exist exist since differing nations have different regulations, such as C2H5COOH USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C2H5COOH DMF submitted to regulatory agencies in the US is known as a USDMF. C2H5COOH USDMF includes data on C2H5COOH's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C2H5COOH USDMF is kept confidential to protect the manufacturer’s intellectual property.
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