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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 ChemWerth Inc
U.S.A
CHEMWERTH INC 33260 PENCICLOVIR 2018-11-07 Active II Complete 2019-01-07 2018-11-06
29/07/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 35243 PENCICLOVIR 2020-09-26 Active II Complete 2022-07-19 2022-05-31