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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
31/10/2025 ChemWerth Inc
U.S.A
CHEMWERTH INC 19978 FOMEPIZOLE 2006-12-13 Active II N/A
31/10/2025 Alcami
U.S.A
STERLING WISCONSIN LLC 19151 FP-059 (FOMEPIZOLE) DRUG SUBSTANCE 2006-02-03 Active II N/A