Aurisco Pharmaceutical Clears Landmark USFDA Oligonucleotide Inspection

The five-day pre-approval inspection focused on the production of Inclisiran Sodium, while also reviewing manufacturing standards for GLP-1 peptides like Semaglutide and Tirzepatide. Following the audit, the USFDA issued an Establishment Inspection Report (EIR) confirming that Aurisco’s corrective and preventive action (CAPA) plans met all regulatory requirements. Inspectors specifically noted the strength of the firm's documentation systems and the technical proficiency of its staff.

Dr. Wang Guoping, the site’s general manager, highlighted the significance of the achievement, noting that the company is now actively working with global agencies to define regulatory pathways for generic oligonucleotides. This milestone enables the future commercialization of generic versions of drugs such as Vutrisiran, Nusinersen, and Eplontersen. Previously audited by the USFDA in 2023, the Yangzhou site serves as both a CDMO provider and a hub for generic API production. Dr. Li Jinliang, a board director at the Shanghai-based firm, credited the successful outcome to the commitment of the internal team and the ongoing support of their global stakeholders.