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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
28/06/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 31161 CANAGLIFLOZIN 2016-12-02 Active II Complete 2017-01-24 2016-11-29
28/06/2025 Alkem Laboratories
India
ALKEM LABORATORIES LTD 30941 CANAGLIFLOZIN 2016-09-16 Active II Complete 2016-12-02 2016-09-26