01 1Bayer AG
01 1ATAMESTANE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8698
Submission : 1990-08-02
Status : Inactive
Type : II
A Atamestane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atamestane, including repackagers and relabelers. The FDA regulates Atamestane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atamestane 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 Atamestane supplier is an individual or a company that provides Atamestane active pharmaceutical ingredient (API) or Atamestane finished formulations upon request. The Atamestane suppliers may include Atamestane API manufacturers, exporters, distributors and traders.
click here to find a list of Atamestane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atamestane DMF (Drug Master File) is a document detailing the whole manufacturing process of Atamestane active pharmaceutical ingredient (API) in detail. Different forms of Atamestane DMFs exist exist since differing nations have different regulations, such as Atamestane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atamestane DMF submitted to regulatory agencies in the US is known as a USDMF. Atamestane USDMF includes data on Atamestane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atamestane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atamestane suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?