01 1AMINO GmbH
01 1BETAINE HCl
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7739
Submission : 1988-10-18
Status : Inactive
Type : II
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A ACIDINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ACIDINE, including repackagers and relabelers. The FDA regulates ACIDINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ACIDINE 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 ACIDINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ACIDINE supplier is an individual or a company that provides ACIDINE active pharmaceutical ingredient (API) or ACIDINE finished formulations upon request. The ACIDINE suppliers may include ACIDINE API manufacturers, exporters, distributors and traders.
click here to find a list of ACIDINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ACIDINE DMF (Drug Master File) is a document detailing the whole manufacturing process of ACIDINE active pharmaceutical ingredient (API) in detail. Different forms of ACIDINE DMFs exist exist since differing nations have different regulations, such as ACIDINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ACIDINE DMF submitted to regulatory agencies in the US is known as a USDMF. ACIDINE USDMF includes data on ACIDINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ACIDINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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