01 1Wisdom Pharmaceutical
01 1FASUDIL HYDROCHLORIDE
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26740
Submission : 2013-02-01
Status : Inactive
Type : II
A Fasudil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasudil, including repackagers and relabelers. The FDA regulates Fasudil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasudil 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 Fasudil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fasudil supplier is an individual or a company that provides Fasudil active pharmaceutical ingredient (API) or Fasudil finished formulations upon request. The Fasudil suppliers may include Fasudil API manufacturers, exporters, distributors and traders.
click here to find a list of Fasudil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fasudil DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasudil active pharmaceutical ingredient (API) in detail. Different forms of Fasudil DMFs exist exist since differing nations have different regulations, such as Fasudil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasudil DMF submitted to regulatory agencies in the US is known as a USDMF. Fasudil USDMF includes data on Fasudil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasudil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fasudil suppliers with USDMF on PharmaCompass.
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