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

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$ API Ref.Price (USD/KG) : 9,876,925Xls download

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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 Concord Biotech
India
CONCORD BIOTECH LTD 34247 DACTINOMYCIN USP 2019-11-06 Active II Complete 2020-02-04 2019-10-25
26/09/2024 SAFC
U.S.A
SIGMA ALDRICH ISRAEL LTD 3538 DACTINOMYCIN USP 1979-04-03 Active II N/A