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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 | Apicore |
India |
APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC) | 41867 | MIGLUSTAT | 2025-06-09 | Active | II | N/A | ||
| 31/10/2025 | Apothecon Pharmaceuticals |
India |
NAVINTA LLC | 36453 | MIGLUSTAT | 2021-11-10 | Active | II | Complete | 2023-09-29 | 2023-09-07 |
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