01 13M Company
01 1CHLOROFLUOROCARBON PROPELLANT P-114 (1,2-DICHLOROTETRAFLUOROETHAN,NF)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11108
Submission : 1994-09-30
Status : Inactive
Type : IV
97
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A CFCl3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CFCl3, including repackagers and relabelers. The FDA regulates CFCl3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CFCl3 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 CFCl3 supplier is an individual or a company that provides CFCl3 active pharmaceutical ingredient (API) or CFCl3 finished formulations upon request. The CFCl3 suppliers may include CFCl3 API manufacturers, exporters, distributors and traders.
click here to find a list of CFCl3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CFCl3 DMF (Drug Master File) is a document detailing the whole manufacturing process of CFCl3 active pharmaceutical ingredient (API) in detail. Different forms of CFCl3 DMFs exist exist since differing nations have different regulations, such as CFCl3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CFCl3 DMF submitted to regulatory agencies in the US is known as a USDMF. CFCl3 USDMF includes data on CFCl3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CFCl3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CFCl3 suppliers with USDMF on PharmaCompass.
