Aurisco Pharmaceutical, a China-based oligonucleotide and peptide manufacturer, said its Yangzhou site has successfully completed a U.S. Food and Drug Administration (FDA) preapproval inspection, which the company claims is the first FDA inspection of a generic oligonucleotide API manufacturer.

The five-day inspection, conducted June 15-19, covered current Good Manufacturing Practice (cGMP) compliance for oligonucleotides, GLP-1 peptides including semaglutide and tirzepatide, as well as small molecule manufacturing. The inspection was related to inclisiran sodium.

According to Aurisco, the FDA’s Establishment Inspection Report (EIR) confirmed that the company had addressed the inspector’s observations through an approved corrective and preventive action (CAPA) plan. The inspector also reviewed the site’s GMP systems, documentation, inspection organization, and personnel expertise.

Aurisco said the inspection could support future development of generic oligonucleotide APIs, including inclisiran, vutrisiran, nusinersen, and eplontersen. The Yangzhou site previously underwent an FDA inspection in 2023 and provides both contract development and manufacturing organization (CDMO) services and generic API manufacturing.