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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 26337 | ETHACRYNIC ACID USP NON-STERILE BULK DRUG | 2013-01-31 | Active | II | Complete | 2013-11-27 | 2013-02-06 |
| 31/10/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 29429 | ETHACRYNIC ACID | 2015-06-06 | Active | II | Complete | 2015-12-17 | 2015-09-08 |
