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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 | TAPI Technology & API Services |
Israel |
TAPI NL BV | 31416 | MACITENTAN | 2017-04-13 | Active | II | Complete | 2017-05-03 | 2017-02-22 |
| 25/04/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 31664 | MACITENTAN | 2017-04-28 | Active | II | Complete | 2017-07-05 | 2017-04-17 |
