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

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$ API Ref.Price (USD/KG) : 341Xls 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
28/10/2024 ASolution Pharmaceuticals
India
ASOLUTION PHARMACEUTICALS PVT LTD 38079 NITROFURANTOIN MONOHYDRATE 2023-05-10 Active II N/A
28/10/2024 Fermion Oy
Finland
FERMION OY 33838 NITROFURANTOIN MONOHYDRATE 2019-10-15 Active II Complete 2020-01-15 2019-11-05