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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
29/11/2025 Shandong Anxin Pharmaceutical
China
SHANDONG ANSHUN PHARMACEUTICAL CO LTD 41696 NUSINERSEN SODIUM 2025-04-17 Active II N/A
29/11/2025 Shanghai Sine Pharmaceutical Laboratories Co.,Ltd.
China
SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTD 41707 NUSINERSEN 2025-03-28 Active II N/A