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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
25/04/2025 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 20633 CARVEDILOL PHOSPHATE HEMIHYDRATE 2007-06-26 Active II Complete 2017-01-19 2016-12-07
25/04/2025 TAPI Technology & API Services
Israel
TAPI NL BV 23312 CARVEDILOL PHOSPHATE 2009-11-25 Active II Complete 2013-06-06 2012-11-13