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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 35424 CALCOBUTROL SODIUM 2020-12-04 Active IV N/A
28/03/2025 Hainan Poly Pharm
China
ANHUI POLY PHARM CO LTD 39309 CALCOBUTROL SODIUM 2023-12-29 Active IV N/A