01 1Bayer AG
01 1QUINESTROL
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3025
Submission : 1977-09-26
Status : Inactive
Type : II
A Quinestrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinestrol, including repackagers and relabelers. The FDA regulates Quinestrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinestrol 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 Quinestrol supplier is an individual or a company that provides Quinestrol active pharmaceutical ingredient (API) or Quinestrol finished formulations upon request. The Quinestrol suppliers may include Quinestrol API manufacturers, exporters, distributors and traders.
click here to find a list of Quinestrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinestrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinestrol active pharmaceutical ingredient (API) in detail. Different forms of Quinestrol DMFs exist exist since differing nations have different regulations, such as Quinestrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinestrol DMF submitted to regulatory agencies in the US is known as a USDMF. Quinestrol USDMF includes data on Quinestrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinestrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinestrol suppliers with USDMF on PharmaCompass.
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