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