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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 42713 | RESMETIROM | 2025-09-30 | Active | II | N/A | ||
| 29/11/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 42172 | RESMETIROM | 2025-08-08 | Active | II | N/A |
