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List of Drug Master Files (DMF) of 03978_FLUKA Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 3,474Xls 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 Axplora
Germany
PHARMAZELL GMBH 32900 METHYLENE BLUE USP 2023-09-21 Active II Complete 2023-12-26 2023-09-26
26/09/2024 ChemWerth Inc
U.S.A
CHEMWERTH INC 36603 METHYLENE BLUE USP 2022-06-01 Active II Complete 2022-06-28 2022-05-10