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