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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
29/07/2025 | Pharmathen SA |
Greece |
PHARMATHEN SA | 31546 | VALGANCICLOVIR HYDROCHLORIDE | 2017-05-12 | Active | II | Complete | 2017-11-07 | 2017-04-28 |
29/07/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 34617 | VALGANCICLOVIR HYDROCHLORIDE USP | 2020-02-29 | Active | II | Complete | 2020-11-30 | 2020-09-29 |