01 2Bayer AG
01 1MS-275
02 1MS-275 FILM-COATED TABLETS
01 2Germany
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20513
Submission : 2007-05-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20512
Submission : 2007-05-02
Status : Inactive
Type : II
A Entinostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entinostat, including repackagers and relabelers. The FDA regulates Entinostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entinostat 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 Entinostat supplier is an individual or a company that provides Entinostat active pharmaceutical ingredient (API) or Entinostat finished formulations upon request. The Entinostat suppliers may include Entinostat API manufacturers, exporters, distributors and traders.
click here to find a list of Entinostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entinostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Entinostat active pharmaceutical ingredient (API) in detail. Different forms of Entinostat DMFs exist exist since differing nations have different regulations, such as Entinostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entinostat DMF submitted to regulatory agencies in the US is known as a USDMF. Entinostat USDMF includes data on Entinostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entinostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entinostat suppliers with USDMF on PharmaCompass.
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