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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 25638 IBANDRONATE SODIUM MONOHYDRATE 2011-12-29 Active II Complete 2016-12-12 2016-06-21
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 20494 IBANDRONATE SODIUM 2007-04-30 Inactive II N/A