01 1Bayer AG
01 1ETHINAMATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4930
Submission : 1983-05-19
Status : Inactive
Type : II
A Ethinamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethinamate, including repackagers and relabelers. The FDA regulates Ethinamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethinamate 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 Ethinamate supplier is an individual or a company that provides Ethinamate active pharmaceutical ingredient (API) or Ethinamate finished formulations upon request. The Ethinamate suppliers may include Ethinamate API manufacturers, exporters, distributors and traders.
click here to find a list of Ethinamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethinamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethinamate active pharmaceutical ingredient (API) in detail. Different forms of Ethinamate DMFs exist exist since differing nations have different regulations, such as Ethinamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethinamate DMF submitted to regulatory agencies in the US is known as a USDMF. Ethinamate USDMF includes data on Ethinamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethinamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethinamate suppliers with USDMF on PharmaCompass.
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