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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 38615 GADOPENTETATE DIMEGLUMINE 2023-07-17 Active II N/A
28/03/2025 Seven Star Pharmaceutical
Taiwan
SEVEN STAR PHARMACEUTICAL CO LTD 26647 GADOPENTETATE DIMEGLUMINE 2012-11-08 Active II Complete 2014-10-27 2014-04-04