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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 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 30526 | ICATIBANT ACETATE | 2016-09-27 | Active | II | Complete | 2016-12-21 | 2016-09-27 |
28/03/2025 | Bachem AG |
Switzerland |
BACHEM AG | 20862 | ICATIBANT ACETATE | 2007-09-17 | Active | II | N/A |