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.
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Aurisco Pharmaceutical Clears Landmark USFDA Oligonucleotide Inspection
Aurisco Pharmaceutical has become the world’s first generic oligonucleotide manufacturer to pass a USFDA inspection. The successful audit of the company’s Yangzhou facility, conducted in June 2026, validates their cGMP compliance for complex molecules and clears a regulatory path for a new wave of affordable generic TIDES therapies.
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.
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