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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
29/11/2025 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 31166 APIXABAN 2016-11-16 Active II Complete 2017-02-10 2016-12-20
29/11/2025 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 30336 APIXABAN 2016-03-14 Active II Complete 2016-08-15 2016-03-28