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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
12/12/2025 Lupin Manufacturing Solutions
India
LUPIN MANUFACTURING SOLUTIONS LTD 31504 CANAGLIFLOZIN HEMIHYDRATE 2017-04-14 Active II Complete 2017-06-01 2017-04-27
29/11/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31161 CANAGLIFLOZIN 2016-12-02 Active II Complete 2017-01-24 2016-11-29