01 1Sinotherapeutics
01 1DAUNORUBICIN
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3643
Submission : 1979-11-09
Status : Inactive
Type : II
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A Daunoblastin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunoblastin, including repackagers and relabelers. The FDA regulates Daunoblastin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunoblastin 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 Daunoblastin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Daunoblastin supplier is an individual or a company that provides Daunoblastin active pharmaceutical ingredient (API) or Daunoblastin finished formulations upon request. The Daunoblastin suppliers may include Daunoblastin API manufacturers, exporters, distributors and traders.
click here to find a list of Daunoblastin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Daunoblastin DMF (Drug Master File) is a document detailing the whole manufacturing process of Daunoblastin active pharmaceutical ingredient (API) in detail. Different forms of Daunoblastin DMFs exist exist since differing nations have different regulations, such as Daunoblastin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daunoblastin DMF submitted to regulatory agencies in the US is known as a USDMF. Daunoblastin USDMF includes data on Daunoblastin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daunoblastin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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