01 13M Company
01 1PERFLUORODICHLOROOCTANE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9912
Submission : 1992-10-16
Status : Inactive
Type : II
A Perfluorodichlorooctane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perfluorodichlorooctane, including repackagers and relabelers. The FDA regulates Perfluorodichlorooctane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perfluorodichlorooctane 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 Perfluorodichlorooctane supplier is an individual or a company that provides Perfluorodichlorooctane active pharmaceutical ingredient (API) or Perfluorodichlorooctane finished formulations upon request. The Perfluorodichlorooctane suppliers may include Perfluorodichlorooctane API manufacturers, exporters, distributors and traders.
click here to find a list of Perfluorodichlorooctane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perfluorodichlorooctane DMF (Drug Master File) is a document detailing the whole manufacturing process of Perfluorodichlorooctane active pharmaceutical ingredient (API) in detail. Different forms of Perfluorodichlorooctane DMFs exist exist since differing nations have different regulations, such as Perfluorodichlorooctane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perfluorodichlorooctane DMF submitted to regulatory agencies in the US is known as a USDMF. Perfluorodichlorooctane USDMF includes data on Perfluorodichlorooctane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perfluorodichlorooctane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perfluorodichlorooctane suppliers with USDMF on PharmaCompass.
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