01 1GALEN LTD
01 1DAUNOXOME FOR INJECTION (DAUNORUBICIN CITRATE LIPOSOME)
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21163
Submission : 2007-12-17
Status : Inactive
Type : II
A Daunorubicin Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunorubicin Citrate, including repackagers and relabelers. The FDA regulates Daunorubicin Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunorubicin Citrate 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 Daunorubicin Citrate supplier is an individual or a company that provides Daunorubicin Citrate active pharmaceutical ingredient (API) or Daunorubicin Citrate finished formulations upon request. The Daunorubicin Citrate suppliers may include Daunorubicin Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Daunorubicin Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daunorubicin Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Daunorubicin Citrate active pharmaceutical ingredient (API) in detail. Different forms of Daunorubicin Citrate DMFs exist exist since differing nations have different regulations, such as Daunorubicin Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daunorubicin Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Daunorubicin Citrate USDMF includes data on Daunorubicin Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daunorubicin Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daunorubicin Citrate suppliers with USDMF on PharmaCompass.
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