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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Emcure Pharmaceuticals |
India |
EMCURE PHARMACEUTICALS LTD | 25763 | IBUTILIDE FUMARATE USP | 2012-03-19 | Active | II | N/A | ||
| 25/04/2025 | Sai Life Sciences Limited |
India |
SAI LIFE SCIENCES LTD | 21470 | IBUTILIDE FUMARATE USP | 2008-03-08 | Active | II | Complete | 2015-09-16 | 2015-09-08 |
