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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
29/01/2026 Aurisco Pharmaceutical
China
YANGZHOU AURISCO PHARMACEUTICAL CO LTD 43092 NUSINERSEN SODIUM 2025-11-20 Active II N/A
29/01/2026 Chongqing Carelife Pharmaceutical
China
CHONGQING CARELIFE PHARMACEUTICAL CO LTD 42251 NUSINERSEN SODIUM, NON-STERILE BULK DRUG SUBSTANCE 2025-07-07 Active II N/A