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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 ChemWerth Inc
U.S.A
CHEMWERTH INC 33811 MITOMYCIN 2019-11-04 Active II N/A
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 13791 MITOMYCIN 1998-09-01 Active II Complete 2012-11-29 2012-11-09