01 1Curia
02 1Viatris
01 1VORINOSTAT
02 1VORINOSTAT DRUG SUBSTANCE
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19093
Submission : 2006-01-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23409
Submission : 2009-12-29
Status : Inactive
Type : II
A Vorinostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vorinostat, including repackagers and relabelers. The FDA regulates Vorinostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vorinostat 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 Vorinostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vorinostat supplier is an individual or a company that provides Vorinostat active pharmaceutical ingredient (API) or Vorinostat finished formulations upon request. The Vorinostat suppliers may include Vorinostat API manufacturers, exporters, distributors and traders.
click here to find a list of Vorinostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vorinostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Vorinostat active pharmaceutical ingredient (API) in detail. Different forms of Vorinostat DMFs exist exist since differing nations have different regulations, such as Vorinostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vorinostat DMF submitted to regulatory agencies in the US is known as a USDMF. Vorinostat USDMF includes data on Vorinostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vorinostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vorinostat suppliers with USDMF on PharmaCompass.
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