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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 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 35518 | APIXABAN | 2020-12-30 | Active | II | N/A |
