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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
25/04/2025 BrightGene Bio-Medical Technology Co.,Ltd
China
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 37214 EXATECAN MESYLATE 2022-06-24 Active II N/A
25/04/2025 Haoyuan Chemexpress Co.Ltd
China
SHANGHAI HAOYUAN CHEMEXPRESS CO LTD 37931 INTERMEDIATE 01 OF EXATECAN 2023-01-16 Active II N/A