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 DM1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DM1, including repackagers and relabelers. The FDA regulates DM1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DM1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A DM1 supplier is an individual or a company that provides DM1 active pharmaceutical ingredient (API) or DM1 finished formulations upon request. The DM1 suppliers may include DM1 API manufacturers, exporters, distributors and traders.
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A DM1 DMF (Drug Master File) is a document detailing the whole manufacturing process of DM1 active pharmaceutical ingredient (API) in detail. Different forms of DM1 DMFs exist exist since differing nations have different regulations, such as DM1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DM1 DMF submitted to regulatory agencies in the US is known as a USDMF. DM1 USDMF includes data on DM1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DM1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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