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