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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
27/02/2026 Bayer AG
Germany
BAYER AG 13063 CALCOBUTROL 1998-07-07 Active IV N/A
27/02/2026 Beijing Beilu Pharma
China
BEIJING BEILU PHARMACEUTICAL CO LTD 40545 CALCOBUTROL 2024-09-23 Active IV N/A