01 1FLUOROMED LP
01 1PERFLUORO(T-BUTYCYCLOHEXANE),96.0%(TRADE NAME APF-150M)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26660
Submission : 2012-11-29
Status : Inactive
Type : II
A Perfluoro T-Butylcyclohexane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perfluoro T-Butylcyclohexane, including repackagers and relabelers. The FDA regulates Perfluoro T-Butylcyclohexane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perfluoro T-Butylcyclohexane 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 Perfluoro T-Butylcyclohexane supplier is an individual or a company that provides Perfluoro T-Butylcyclohexane active pharmaceutical ingredient (API) or Perfluoro T-Butylcyclohexane finished formulations upon request. The Perfluoro T-Butylcyclohexane suppliers may include Perfluoro T-Butylcyclohexane API manufacturers, exporters, distributors and traders.
click here to find a list of Perfluoro T-Butylcyclohexane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perfluoro T-Butylcyclohexane DMF (Drug Master File) is a document detailing the whole manufacturing process of Perfluoro T-Butylcyclohexane active pharmaceutical ingredient (API) in detail. Different forms of Perfluoro T-Butylcyclohexane DMFs exist exist since differing nations have different regulations, such as Perfluoro T-Butylcyclohexane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perfluoro T-Butylcyclohexane DMF submitted to regulatory agencies in the US is known as a USDMF. Perfluoro T-Butylcyclohexane USDMF includes data on Perfluoro T-Butylcyclohexane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perfluoro T-Butylcyclohexane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perfluoro T-Butylcyclohexane suppliers with USDMF on PharmaCompass.
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