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    List of Drug Master Files (DMF) of 5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    5,12-Naphthacenedione, 10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)-

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    $ API Ref.Price (USD/KG) : 34,600Xls download

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    26/09/2024 DZD Heze Pharmaceutical Co Ltd
    China
    		 DZD HEZE PHARMACEUTICAL CO LTD 31153 DOXORUBICIN HYDROCHLORIDE 2016-11-11 Active II Complete 2024-08-27 2024-07-18
    26/09/2024 Meiji Seika Pharma
    Japan
    		 MEIJI SEIKA PHARMA CO LTD 13209 DOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE 1998-04-30 Active II Complete 2017-10-18 2015-12-28