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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 12/12/2025 | Lupin Manufacturing Solutions |
India |
LUPIN MANUFACTURING SOLUTIONS LTD | 31504 | CANAGLIFLOZIN HEMIHYDRATE | 2017-04-14 | Active | II | Complete | 2017-06-01 | 2017-04-27 |
| 29/11/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 31161 | CANAGLIFLOZIN | 2016-12-02 | Active | II | Complete | 2017-01-24 | 2016-11-29 |
