01 1Bayer AG
01 1ETOFENAMATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5633
Submission : 1984-12-12
Status : Inactive
Type : II
A Etofenamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etofenamate, including repackagers and relabelers. The FDA regulates Etofenamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etofenamate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Etofenamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etofenamate supplier is an individual or a company that provides Etofenamate active pharmaceutical ingredient (API) or Etofenamate finished formulations upon request. The Etofenamate suppliers may include Etofenamate API manufacturers, exporters, distributors and traders.
click here to find a list of Etofenamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etofenamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Etofenamate active pharmaceutical ingredient (API) in detail. Different forms of Etofenamate DMFs exist exist since differing nations have different regulations, such as Etofenamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etofenamate DMF submitted to regulatory agencies in the US is known as a USDMF. Etofenamate USDMF includes data on Etofenamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etofenamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etofenamate suppliers with USDMF on PharmaCompass.
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