01 1Eisai
02 1Blank
01 1BENTIROMIDE
02 1BENTIROMIDE(BTABA= E-2663) AND INTERMEDIATE
01 1Japan
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5395
Submission : 1984-05-31
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3713
Submission : 1980-02-01
Status : Inactive
Type : II
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Corporate PDF
A Bentiromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bentiromide, including repackagers and relabelers. The FDA regulates Bentiromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bentiromide 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 Bentiromide supplier is an individual or a company that provides Bentiromide active pharmaceutical ingredient (API) or Bentiromide finished formulations upon request. The Bentiromide suppliers may include Bentiromide API manufacturers, exporters, distributors and traders.
click here to find a list of Bentiromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bentiromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Bentiromide active pharmaceutical ingredient (API) in detail. Different forms of Bentiromide DMFs exist exist since differing nations have different regulations, such as Bentiromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bentiromide DMF submitted to regulatory agencies in the US is known as a USDMF. Bentiromide USDMF includes data on Bentiromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bentiromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bentiromide suppliers with USDMF on PharmaCompass.
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