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List of Drug Master Files (DMF) of Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, gamma-lactone, methyl ester, (7alpha,11alpha,17alpha)- Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 2,242Xls 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 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 19796 EPLERENONE MEK HEMISOLVATE (1:0.5) 2006-09-25 Inactive II N/A
26/09/2024 Aurisco Pharmaceutical
China
AURISCO PHARMACEUTICAL CO LTD 27672 EPLERENONE 2013-12-25 Active II Complete 2015-10-30 2013-12-02