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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
28/03/2025 Pharmathen SA
Greece
PHARMATHEN SA 31546 VALGANCICLOVIR HYDROCHLORIDE 2017-05-12 Active II Complete 2017-11-07 2017-04-28
28/03/2025 Ajanta Pharma Limited
India
AJANTA PHARMA LTD 36194 VALGANCICLOVIR HYDROCHLORIDE USP (Crystalline) 2021-10-22 Active II Complete 2021-12-03 2021-10-13