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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 35047 GADOTERIDOL 2020-07-31 Active II Complete 2020-11-03 2020-09-24
28/03/2025 Hainan Poly Pharm
China
ANHUI POLY PHARM CO LTD 37960 GADOTERIDOL USP 2023-02-09 Active II Complete 2023-03-21 2023-02-03