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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/01/2026 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 42355 | DARIDOREXANT HYDROCHLORIDE | 2025-07-31 | Active | II | N/A | ||
| 05/02/2026 | ALP Pharm |
China |
ALP PHARM BEIJING CO LTD | 42891 | DARIDOREXANT HYDROCHLORIDE , NON STERILE | 2025-10-28 | Active | II | N/A |
