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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
28/03/2025 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 38964 ISAVUCONAZONIUM SULFATE 2023-10-04 Active II N/A
28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 38781 ISAVUCONAZONIUM SULFATE 2023-09-22 Active II Complete 2023-11-08 2023-09-28