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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
24/02/2025 Concord Biotech
India
CONCORD BIOTECH LTD 34247 DACTINOMYCIN USP 2019-11-06 Active II Complete 2020-02-04 2019-10-25
24/02/2025 SAFC
U.S.A
SIGMA ALDRICH ISRAEL LTD 3538 DACTINOMYCIN USP 1979-04-03 Active II N/A