01 1Daiichi Sankyo
01 1CS-780 DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14202
Submission : 1999-06-15
Status : Inactive
Type : II
A Benfluorexum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benfluorexum, including repackagers and relabelers. The FDA regulates Benfluorexum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benfluorexum 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 Benfluorexum supplier is an individual or a company that provides Benfluorexum active pharmaceutical ingredient (API) or Benfluorexum finished formulations upon request. The Benfluorexum suppliers may include Benfluorexum API manufacturers, exporters, distributors and traders.
click here to find a list of Benfluorexum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benfluorexum DMF (Drug Master File) is a document detailing the whole manufacturing process of Benfluorexum active pharmaceutical ingredient (API) in detail. Different forms of Benfluorexum DMFs exist exist since differing nations have different regulations, such as Benfluorexum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benfluorexum DMF submitted to regulatory agencies in the US is known as a USDMF. Benfluorexum USDMF includes data on Benfluorexum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benfluorexum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benfluorexum suppliers with USDMF on PharmaCompass.
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