- Aurisco Pharmaceutical’s Yangzhou, China, facility has passed a USFDA pre-approval inspection, becoming the first generic oligonucleotide API manufacturer to achieve this milestone.
- The five-day inspection covered cGMP compliance for oligonucleotides, GLP-1 peptides, and small molecules, supporting future production of generic TIDES APIs and CDMO services.
Aurisco Pharmaceutical announced that its manufacturing site in Yangzhou, China, has passed a U.S. Food and Drug Administration (USFDA) pre-approval inspection, making it the first generic oligonucleotide active pharmaceutical ingredient (API) manufacturer to achieve this milestone. The five-day inspection, conducted from June 15–19, 2026, focused on cGMP compliance for the production of Inclisiran Sodium and also covered oligonucleotides, GLP-1 peptides, including semaglutide and tirzepatide, and small molecules.
The company said the Establishment Inspection Report (EIR) confirmed that it had addressed the inspector’s observations through an approved corrective and preventive action (CAPA) plan. According to Aurisco, the inspector confirmed satisfaction with the site’s facilities, GMP systems, documentation, inspection organization, and the knowledge of its personnel. The Yangzhou facility, which was previously inspected by the USFDA in 2023, provides CDMO services in addition to manufacturing generic APIs.
“This was the first FDA inspection to a generic oligonucleotide manufacturer. We are collaborating with agencies worldwide to establish pathways for generic TIDES.”
Dr. Wang Guoping, General Manager of the Yangzhou site
Aurisco said the inspection supports future production of generic oligonucleotide APIs, including Inclisiran, Vutrisiran, Nusinersen, and Eplontersen. The company stated that the facility’s capabilities span oligonucleotides, GLP-1 peptides, and small molecules, supporting both API production and contract manufacturing services.
