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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