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01 1PERFLUORODECYL BROMIDE C10F21BR
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10644
Submission : 1993-12-28
Status : Inactive
Type : II
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A Perflubrodec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perflubrodec, including repackagers and relabelers. The FDA regulates Perflubrodec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perflubrodec 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 Perflubrodec supplier is an individual or a company that provides Perflubrodec active pharmaceutical ingredient (API) or Perflubrodec finished formulations upon request. The Perflubrodec suppliers may include Perflubrodec API manufacturers, exporters, distributors and traders.
click here to find a list of Perflubrodec suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perflubrodec DMF (Drug Master File) is a document detailing the whole manufacturing process of Perflubrodec active pharmaceutical ingredient (API) in detail. Different forms of Perflubrodec DMFs exist exist since differing nations have different regulations, such as Perflubrodec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perflubrodec DMF submitted to regulatory agencies in the US is known as a USDMF. Perflubrodec USDMF includes data on Perflubrodec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perflubrodec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perflubrodec suppliers with USDMF on PharmaCompass.
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