01 1Roche Diagnostics GmbH
01 1GUAIACOL-O-ETHYLBENZYLAMINE HCL
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17043
Submission : 2003-12-16
Status : Inactive
Type : II
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A benzyl amine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of benzyl amine, including repackagers and relabelers. The FDA regulates benzyl amine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. benzyl amine 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 benzyl amine supplier is an individual or a company that provides benzyl amine active pharmaceutical ingredient (API) or benzyl amine finished formulations upon request. The benzyl amine suppliers may include benzyl amine API manufacturers, exporters, distributors and traders.
click here to find a list of benzyl amine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A benzyl amine DMF (Drug Master File) is a document detailing the whole manufacturing process of benzyl amine active pharmaceutical ingredient (API) in detail. Different forms of benzyl amine DMFs exist exist since differing nations have different regulations, such as benzyl amine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A benzyl amine DMF submitted to regulatory agencies in the US is known as a USDMF. benzyl amine USDMF includes data on benzyl amine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The benzyl amine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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