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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 Biophore India Pharmaceuticals Pvt Ltd
India
BIOPHORE INDIA PHARMACEUTICALS PVT LTD 35991 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID 2021-06-28 Active II Complete 2021-09-29 2021-08-18
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 36152 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID 2021-08-05 Active II Complete 2021-11-10 2021-08-02