01 1Asahi Kasei Finechem
01 1FASUDIL HYDROCHLORIDE HYDRATE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15639
Submission : 2001-09-21
Status : Inactive
Type : II
A Fasudil Hydrochloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasudil Hydrochloride Hydrate, including repackagers and relabelers. The FDA regulates Fasudil Hydrochloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasudil Hydrochloride Hydrate 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 Fasudil Hydrochloride Hydrate supplier is an individual or a company that provides Fasudil Hydrochloride Hydrate active pharmaceutical ingredient (API) or Fasudil Hydrochloride Hydrate finished formulations upon request. The Fasudil Hydrochloride Hydrate suppliers may include Fasudil Hydrochloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fasudil Hydrochloride Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fasudil Hydrochloride Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasudil Hydrochloride Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Fasudil Hydrochloride Hydrate DMFs exist exist since differing nations have different regulations, such as Fasudil Hydrochloride Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasudil Hydrochloride Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fasudil Hydrochloride Hydrate USDMF includes data on Fasudil Hydrochloride Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasudil Hydrochloride Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fasudil Hydrochloride Hydrate suppliers with USDMF on PharmaCompass.
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