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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 Fuxin Long Rui Pharmaceutical
China
FUXIN LONG RUI PHARMACEUTICAL CO LTD 33792 IPRAGLIFLOZIN L-PROLINE 2019-07-19 Active II N/A
28/03/2025 Maithri Drugs
India
MAITHRI DRUGS PRIVATE LTD 39593 IPRAGLIFLOZIN L-PROLINE 2024-03-01 Active II N/A