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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | HRV Pharma |
India |
NEW HORIZON PHARMA US INC | 39721 | PITOLISANT HYDROCHLORIDE IN-HOUSE | 2024-04-01 | Active | II | N/A | ||
| 29/11/2025 | Nuray Chemicals Private Limited |
India |
NURAY CHEMICALS PVT LTD | 36859 | PITOLISANT HYDROCHLORIDE | 2022-03-01 | Active | II | Complete | 2023-03-31 | 2023-03-15 |
