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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 | Macsen Labs |
India |
MACSEN DRUGS | 40119 | INDIGOTINDISULFONATE SODIUM USP | 2024-06-25 | Active | II | N/A | ||
| 31/10/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 31299 | INDIGOTIN DISULFONATE SODIUM | 2017-01-09 | Active | II | Complete | 2017-02-15 | 2017-01-12 |
