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
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PharmaCompass offers a list of Rebamipide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rebamipide manufacturer or Rebamipide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rebamipide manufacturer or Rebamipide supplier.
PharmaCompass also assists you with knowing the Rebamipide API Price utilized in the formulation of products. Rebamipide API Price is not always fixed or binding as the Rebamipide Price is obtained through a variety of data sources. The Rebamipide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rebagen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rebagen, including repackagers and relabelers. The FDA regulates Rebagen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rebagen 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 Rebagen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rebagen supplier is an individual or a company that provides Rebagen active pharmaceutical ingredient (API) or Rebagen finished formulations upon request. The Rebagen suppliers may include Rebagen API manufacturers, exporters, distributors and traders.
click here to find a list of Rebagen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rebagen DMF (Drug Master File) is a document detailing the whole manufacturing process of Rebagen active pharmaceutical ingredient (API) in detail. Different forms of Rebagen DMFs exist exist since differing nations have different regulations, such as Rebagen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rebagen DMF submitted to regulatory agencies in the US is known as a USDMF. Rebagen USDMF includes data on Rebagen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rebagen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rebagen suppliers with USDMF on PharmaCompass.
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