01 1Jiangxi Synergy Pharmaceutical
02 1Otsuka Chemical Co Ltd
01 1REBAMIPIDE
02 1REBAMIPIDE(OPC-12759) DRUG SUBSTANCE
01 1China
02 1Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21700
Submission : 2008-06-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15001
Submission : 2000-08-10
Status : Inactive
Type : II
A Rebamipide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rebamipide, including repackagers and relabelers. The FDA regulates Rebamipide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rebamipide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Rebamipide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rebamipide supplier is an individual or a company that provides Rebamipide active pharmaceutical ingredient (API) or Rebamipide finished formulations upon request. The Rebamipide suppliers may include Rebamipide API manufacturers, exporters, distributors and traders.
click here to find a list of Rebamipide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rebamipide DMF (Drug Master File) is a document detailing the whole manufacturing process of Rebamipide active pharmaceutical ingredient (API) in detail. Different forms of Rebamipide DMFs exist exist since differing nations have different regulations, such as Rebamipide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rebamipide DMF submitted to regulatory agencies in the US is known as a USDMF. Rebamipide USDMF includes data on Rebamipide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rebamipide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rebamipide suppliers with USDMF on PharmaCompass.
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