Aurisco Pharmaceutical said its Yangzhou, China site passed a USFDA inspection, which it described as the first such review of a generic oligonucleotide API manufacturer globally. The five-day pre-approval inspection for Inclisiran Sodium ran from June 15 to June 19, 2026 and covered cGMP compliance across oligonucleotides, GLP-1 peptides such as Semaglutide and Tirzepatide, and small molecules. Aurisco said the EIR letter confirmed it had addressed the inspector's observations through an approved CAPA plan, and added that the inspector was satisfied with the facilities, GMP system, documentation, inspection organization and staff knowledge. The company said the outcome could support future generic oligonucleotides including Inclisiran, Vutrisiran, Nusinersen and Eplontersen. Aurisco added that the site was also successfully inspected by USFDA in 2023 and provides CDMO services and generic APIs.