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List of Drug Master Files (DMF) of GW282974X Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 2,937Xls 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 ChemWerth Inc
U.S.A
CHEMWERTH INC 34836 LAPATINIB DITOSYLATE MONOHYDRATE 2021-02-05 Active II N/A
26/09/2024 Minakem (formerly Delmar Chemicals)
Canada
DELMAR CHEMICALS INC 32266 LAPATINIB DITOSYLATE 2018-01-17 Active II Complete 2018-12-03 2018-01-24