01 1Bayer AG
01 1MESTEROLONE (SH723)
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2077
Submission : 1973-03-05
Status : Inactive
Type : II
A Mesterolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mesterolone, including repackagers and relabelers. The FDA regulates Mesterolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mesterolone 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 Mesterolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mesterolone supplier is an individual or a company that provides Mesterolone active pharmaceutical ingredient (API) or Mesterolone finished formulations upon request. The Mesterolone suppliers may include Mesterolone API manufacturers, exporters, distributors and traders.
click here to find a list of Mesterolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mesterolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Mesterolone active pharmaceutical ingredient (API) in detail. Different forms of Mesterolone DMFs exist exist since differing nations have different regulations, such as Mesterolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mesterolone DMF submitted to regulatory agencies in the US is known as a USDMF. Mesterolone USDMF includes data on Mesterolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mesterolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mesterolone suppliers with USDMF on PharmaCompass.
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