01 1Abbott Laboratories
01 1BIFEPRUNOX MESYLATE BULK DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19560
Submission : 2006-06-29
Status : Inactive
Type : II
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PharmaCompass offers a list of Bifeprunox API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bifeprunox manufacturer or Bifeprunox supplier for your needs.
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A Bifeprunox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bifeprunox, including repackagers and relabelers. The FDA regulates Bifeprunox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bifeprunox 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 Bifeprunox supplier is an individual or a company that provides Bifeprunox active pharmaceutical ingredient (API) or Bifeprunox finished formulations upon request. The Bifeprunox suppliers may include Bifeprunox API manufacturers, exporters, distributors and traders.
click here to find a list of Bifeprunox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bifeprunox DMF (Drug Master File) is a document detailing the whole manufacturing process of Bifeprunox active pharmaceutical ingredient (API) in detail. Different forms of Bifeprunox DMFs exist exist since differing nations have different regulations, such as Bifeprunox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bifeprunox DMF submitted to regulatory agencies in the US is known as a USDMF. Bifeprunox USDMF includes data on Bifeprunox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bifeprunox USDMF is kept confidential to protect the manufacturer’s intellectual property.
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