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