01 1HUYA Bioscience International
01 1HBI-8000 DRUG PRODUCT
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29908
Submission : 2016-01-08
Status : Inactive
Type : II
A Tucidinostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tucidinostat, including repackagers and relabelers. The FDA regulates Tucidinostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tucidinostat 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 Tucidinostat supplier is an individual or a company that provides Tucidinostat active pharmaceutical ingredient (API) or Tucidinostat finished formulations upon request. The Tucidinostat suppliers may include Tucidinostat API manufacturers, exporters, distributors and traders.
click here to find a list of Tucidinostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tucidinostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Tucidinostat active pharmaceutical ingredient (API) in detail. Different forms of Tucidinostat DMFs exist exist since differing nations have different regulations, such as Tucidinostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tucidinostat DMF submitted to regulatory agencies in the US is known as a USDMF. Tucidinostat USDMF includes data on Tucidinostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tucidinostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tucidinostat suppliers with USDMF on PharmaCompass.
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