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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 36148 | GADOTERATE MEGLUMINE | 2021-07-29 | Active | II | N/A | ||
24/02/2025 | Formosa Laboratories |
Taiwan |
FORMOSA LABORATORIES INC | 34129 | GADOTERATE MEGLUMINE | 2019-09-12 | Active | II | Complete | 2019-11-06 | 2019-09-26 |