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
17
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A Daunorubicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunorubicin, including repackagers and relabelers. The FDA regulates Daunorubicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunorubicin 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 Daunorubicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Daunorubicin supplier is an individual or a company that provides Daunorubicin active pharmaceutical ingredient (API) or Daunorubicin finished formulations upon request. The Daunorubicin suppliers may include Daunorubicin API manufacturers, exporters, distributors and traders.
click here to find a list of Daunorubicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Daunorubicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Daunorubicin active pharmaceutical ingredient (API) in detail. Different forms of Daunorubicin DMFs exist exist since differing nations have different regulations, such as Daunorubicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daunorubicin DMF submitted to regulatory agencies in the US is known as a USDMF. Daunorubicin USDMF includes data on Daunorubicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daunorubicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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