01 1Pfizer Inc
01 1FLUOXYMESTERONE USP
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4607
Submission : 1982-07-23
Status : Inactive
Type : II
47
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A Testoral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testoral, including repackagers and relabelers. The FDA regulates Testoral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testoral 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 Testoral manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Testoral supplier is an individual or a company that provides Testoral active pharmaceutical ingredient (API) or Testoral finished formulations upon request. The Testoral suppliers may include Testoral API manufacturers, exporters, distributors and traders.
click here to find a list of Testoral suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Testoral DMF (Drug Master File) is a document detailing the whole manufacturing process of Testoral active pharmaceutical ingredient (API) in detail. Different forms of Testoral DMFs exist exist since differing nations have different regulations, such as Testoral USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testoral DMF submitted to regulatory agencies in the US is known as a USDMF. Testoral USDMF includes data on Testoral's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testoral USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testoral suppliers with USDMF on PharmaCompass.
