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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 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 41086 | VORTIOXETINE HYDROCHLORIDE | 2024-12-31 | Active | II | N/A | ||
| 31/10/2025 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 29211 | ATOMOXETINE HYDROCHLORIDE USP | 2015-03-26 | Active | II | Complete | 2019-12-27 | 2019-12-03 |
