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 Freon® 11 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Freon® 11, including repackagers and relabelers. The FDA regulates Freon® 11 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Freon® 11 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 Freon® 11 supplier is an individual or a company that provides Freon® 11 active pharmaceutical ingredient (API) or Freon® 11 finished formulations upon request. The Freon® 11 suppliers may include Freon® 11 API manufacturers, exporters, distributors and traders.
click here to find a list of Freon® 11 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Freon® 11 DMF (Drug Master File) is a document detailing the whole manufacturing process of Freon® 11 active pharmaceutical ingredient (API) in detail. Different forms of Freon® 11 DMFs exist exist since differing nations have different regulations, such as Freon® 11 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Freon® 11 DMF submitted to regulatory agencies in the US is known as a USDMF. Freon® 11 USDMF includes data on Freon® 11's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Freon® 11 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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