01 1Bayer AG
01 1ONAPRISTONE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10672
Submission : 1993-12-22
Status : Inactive
Type : II
A Onapristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onapristone, including repackagers and relabelers. The FDA regulates Onapristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onapristone 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 Onapristone supplier is an individual or a company that provides Onapristone active pharmaceutical ingredient (API) or Onapristone finished formulations upon request. The Onapristone suppliers may include Onapristone API manufacturers, exporters, distributors and traders.
click here to find a list of Onapristone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Onapristone DMF (Drug Master File) is a document detailing the whole manufacturing process of Onapristone active pharmaceutical ingredient (API) in detail. Different forms of Onapristone DMFs exist exist since differing nations have different regulations, such as Onapristone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Onapristone DMF submitted to regulatory agencies in the US is known as a USDMF. Onapristone USDMF includes data on Onapristone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Onapristone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Onapristone suppliers with USDMF on PharmaCompass.
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