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01 1OXYMETHOLONE USP
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6432
Submission : 1986-06-17
Status : Inactive
Type : II
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A Oxymetholone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxymetholone, including repackagers and relabelers. The FDA regulates Oxymetholone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxymetholone 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 Oxymetholone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxymetholone supplier is an individual or a company that provides Oxymetholone active pharmaceutical ingredient (API) or Oxymetholone finished formulations upon request. The Oxymetholone suppliers may include Oxymetholone API manufacturers, exporters, distributors and traders.
click here to find a list of Oxymetholone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxymetholone DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxymetholone active pharmaceutical ingredient (API) in detail. Different forms of Oxymetholone DMFs exist exist since differing nations have different regulations, such as Oxymetholone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxymetholone DMF submitted to regulatory agencies in the US is known as a USDMF. Oxymetholone USDMF includes data on Oxymetholone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxymetholone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxymetholone suppliers with USDMF on PharmaCompass.
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