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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 26266 | CARBAMAZEPINE | 2012-07-31 | Active | II | Complete | 2015-12-16 | 2015-06-25 |
| 31/10/2025 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 4719 | CARBAMAZEPINE USP | 1982-11-10 | Active | II | Complete | 2012-11-30 | 2012-11-13 |
