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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
30/12/2024 Medichem S.A
Spain
MEDICHEM MANUFACTURING MALTA LTD 30559 SUNITINIB MALATE 2016-06-03 Active II Complete 2016-08-11 2016-06-02
30/12/2024 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 23414 SUNITINIB MALATE 2009-12-29 Active II Complete 2012-11-23 2012-11-13