01 1Daiichi Sankyo
01 1EPIRIZOLE (MEBRON)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2684
Submission : 1976-06-15
Status : Inactive
Type : II
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PharmaCompass offers a list of Mepirizole 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 Mepirizole manufacturer or Mepirizole supplier for your needs.
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A Epirizol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epirizol, including repackagers and relabelers. The FDA regulates Epirizol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epirizol 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 Epirizol supplier is an individual or a company that provides Epirizol active pharmaceutical ingredient (API) or Epirizol finished formulations upon request. The Epirizol suppliers may include Epirizol API manufacturers, exporters, distributors and traders.
click here to find a list of Epirizol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Epirizol DMF (Drug Master File) is a document detailing the whole manufacturing process of Epirizol active pharmaceutical ingredient (API) in detail. Different forms of Epirizol DMFs exist exist since differing nations have different regulations, such as Epirizol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epirizol DMF submitted to regulatory agencies in the US is known as a USDMF. Epirizol USDMF includes data on Epirizol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epirizol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epirizol suppliers with USDMF on PharmaCompass.
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