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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 Biocon
India
BIOCON LTD 32877 ANIDULAFUNGIN (DRUG SUBSTANCE INTERMEDIATE) 2018-06-12 Active II N/A
28/03/2025 BrightGene Bio-Medical Technology Co.,Ltd
China
BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD 32010 ANIDULAFUNGIN (NON-STERILE API) 2017-08-28 Active II N/A