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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 41091 | VORTIOXETINE HYDROBROMIDE | 2024-12-31 | Active | II | N/A | ||
28/03/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 31281 | VORTIOXETINE HYDROBROMIDE | 2016-12-30 | Active | II | Complete | 2017-02-01 | 2016-12-27 |