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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 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 37632 | MIGALASTAT HYDROCHLORIDE | 2023-02-26 | Active | II | N/A | ||
| 25/04/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 36827 | MIGALASTAT HYDROCHLORIDE | 2022-02-25 | Active | II | Complete | 2022-04-08 | 2022-02-25 |
