01 1Eisai
01 1EPERISONE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8004
Submission : 1989-04-04
Status : Inactive
Type : II
A Eperisone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eperisone, including repackagers and relabelers. The FDA regulates Eperisone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eperisone 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 Eperisone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eperisone supplier is an individual or a company that provides Eperisone active pharmaceutical ingredient (API) or Eperisone finished formulations upon request. The Eperisone suppliers may include Eperisone API manufacturers, exporters, distributors and traders.
click here to find a list of Eperisone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eperisone DMF (Drug Master File) is a document detailing the whole manufacturing process of Eperisone active pharmaceutical ingredient (API) in detail. Different forms of Eperisone DMFs exist exist since differing nations have different regulations, such as Eperisone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eperisone DMF submitted to regulatory agencies in the US is known as a USDMF. Eperisone USDMF includes data on Eperisone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eperisone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eperisone suppliers with USDMF on PharmaCompass.
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