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List of Drug Master Files (DMF) of Penciclovir Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 ChemWerth Inc
U.S.A
CHEMWERTH INC 33260 PENCICLOVIR 2018-11-07 Active II Complete 2019-01-07 2018-11-06
26/09/2024 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 35032 PENCICLOVIR 2020-09-30 Active II Complete 2020-11-12 2020-09-29