01 1Curia
02 1Pfizer Inc
01 1FLUOXYMESTERONE ACTIVE DRUG SUBSTANCE
02 1FLUOXYMESTERONE USP
01 2U.S.A
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-07-08
DMF Number : 27250
Submission : 2013-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4607
Submission : 1982-07-23
Status : Inactive
Type : II
A Fluoxymesterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluoxymesterone, including repackagers and relabelers. The FDA regulates Fluoxymesterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluoxymesterone 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 Fluoxymesterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluoxymesterone supplier is an individual or a company that provides Fluoxymesterone active pharmaceutical ingredient (API) or Fluoxymesterone finished formulations upon request. The Fluoxymesterone suppliers may include Fluoxymesterone API manufacturers, exporters, distributors and traders.
click here to find a list of Fluoxymesterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluoxymesterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluoxymesterone active pharmaceutical ingredient (API) in detail. Different forms of Fluoxymesterone DMFs exist exist since differing nations have different regulations, such as Fluoxymesterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluoxymesterone DMF submitted to regulatory agencies in the US is known as a USDMF. Fluoxymesterone USDMF includes data on Fluoxymesterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluoxymesterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluoxymesterone suppliers with USDMF on PharmaCompass.
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