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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
29/01/2026 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 31166 APIXABAN 2016-11-16 Active II Complete 2017-02-10 2016-12-20
29/01/2026 ApiSyn
India
APISYN HEALTHCARE PRIVATE LTD 42365 APIXABAN 2025-08-27 Active II N/A