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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
28/06/2025 CHEMO IBERICA SA
Spain
QUIMICA SINTETICA SA 17367 ISRADIPINE 2004-05-05 Active II Complete 2014-10-10 2014-03-20
28/06/2025 Magle Chemoswed
Sweden
CHEMOSWED AB 19376 ISRADIPINE 2006-04-19 Active II N/A