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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 |