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