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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
27/09/2025 | Cipla |
India |
CIPLA LTD | 40972 | Resmetirom | 2025-02-28 | Active | II | N/A | ||
07/10/2025 | Lee Pharma |
India |
LEE PHARMA LTD | 41897 | RESMETIROM (LP FORM) | 2025-05-23 | Active | II | N/A |