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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 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 35991 | ERTUGLIFLOZIN L-PYROGLUTAMIC ACID | 2021-06-28 | Active | II | Complete | 2021-09-29 | 2021-08-18 |
| 31/10/2025 | Honour Lab Limited |
India |
HONOUR LAB LIMITED | 36283 | ERTUGLIFLOZIN L-PYROGLUTAMIC ACID | 2021-09-30 | Active | II | Complete | 2021-10-25 | 2021-09-14 |
