Aurisco announced that its wholly owned subsidiary Yangzhou Aurisco received a notification letter and on-site inspection report from the U.S. FDA, confirming that its quality management system meets U.S. FDA standards and successfully passed the pre-approval inspection as well as routine GMP compliance inspection for marketed products. The inspection scope covered products including inclisiran sodium, semaglutide, clascoterone, and brivaracetam. The announcement showed that inclisiran sodium is an active pharmaceutical ingredient used to treat adult primary hypercholesterolemia, with global sales of approximately 1.198 billion U.S. dollars in 2025; semaglutide is used for glucose lowering and weight reduction, with global sales of approximately 36.1 billion U.S. dollars in 2025.
Aurisco Pharmaceutical Co LtdPassed U.S. FDA on-site inspection for GMP compliance and pre-approval, covering key products.
