en.Wedoany.com Reported - Aurisco Pharmaceutical announced on August 14, 2026, that its facility in Yangzhou, China, has passed an inspection by the U.S. Food and Drug Administration (USFDA), making it the world's first generic oligonucleotide active pharmaceutical ingredient manufacturer to pass the inspection. The company is one of the world's leading manufacturers of oligonucleotides and peptides (TIDES).

The USFDA pre-approval inspection for Inclisiran Sodium proceeded as scheduled over five days (June 15–19, 2026), covering compliance with Good Manufacturing Practices (BPFa/GMP) for oligonucleotides, GLP-1 peptides (such as semaglutide and tirzepatide), and small molecules.

The Establishment Inspection Report (EIR) confirmed that Aurisco fully responded to the inspector's observations through an approved Corrective and Preventive Action (CAPA) plan. The inspector expressed satisfaction with the facility and commended Aurisco's BPF systems, documentation, inspection organization, and the professional competence of its team members.

Dr. Wang Guoping, General Manager of the facility, stated that this was the first inspection of a generic oligonucleotide manufacturer by the USFDA, and that the company is collaborating with agencies worldwide to build a pipeline of generic TIDES. This inspection paves the way for future generic oligonucleotides (Inclisiran, Vutrisiran, Nusinersen, Eplontersen, etc.). The facility previously passed a USFDA inspection in 2023 and currently offers CDMO services as well as generic active pharmaceutical ingredients.

Dr. Li Jinliang, Board Member, stated that this inspection marks the beginning of a new era for patients, who will gain access to safe and affordable oligonucleotides. He also thanked the Aurisco team for their unwavering dedication, as well as customers and shareholders for their continued trust and support.

Aurisco Pharmaceutical Co., Ltd. (SSE:605116) has been active in the international market since 1998 and now operates 6 R&D centers, 4 production bases, and commercial offices in the United States, Portugal, India, and Brazil, with a commitment to manufacturing complex products. The company has filed over 100 patents globally and employs 300 scientists, providing a safe intellectual property environment for new chemical entities (SCN/NCE) and complex generics, while complying with BPF and ESG standards.

Aurisco holds the EcoVadis Gold certification and has joined SBTi, M2030, and SPP. The company has passed the RX360 supply chain security inspection and has undergone an audit by the Pharmaceutical Supply Chain Initiative (PSCI).