Aurisco Pharmaceutical has announced that its manufacturing site in Yangzhou, China, has successfully passed a U.S. Food and Drug Administration (FDA) inspection. The company said the site is the first generic oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in the world to pass a USFDA inspection.
The FDA carried out a five-day pre-approval inspection at the Yangzhou site from June 15 to June 19, 2026. The inspection was linked to Inclisiran Sodium and reviewed the company’s compliance with current good manufacturing practices (cGMP).
The inspection covered the manufacturing of oligonucleotides, GLP-1 peptides and small-molecule medicines. Products reviewed during the inspection included peptide medicines such as semaglutide and tirzepatide.
Aurisco said the FDA’s Establishment Inspection Report (EIR) confirmed that the company had successfully addressed the observations made during the inspection through an approved corrective and preventive action (CAPA) plan.
The FDA inspector also expressed satisfaction with the company’s manufacturing facilities and systems. According to Aurisco, the inspector highlighted the company’s GMP system, documentation, inspection organization and the knowledge of its employees.
The successful FDA inspection is an important step for Aurisco as it works to expand its generic oligonucleotide business. Oligonucleotides are short pieces of genetic material that can be designed to target specific genes or proteins. They are being used in an increasing number of medicines for conditions including cardiovascular disease, neurological disorders and rare diseases.
Aurisco said the inspection could also help open the way for future generic versions of several oligonucleotide medicines. These include inclisiran, vutrisiran, nusinersen and eplontersen.
Inclisiran is an oligonucleotide medicine used to help lower low-density lipoprotein (LDL) cholesterol. The other medicines are being used or developed for different diseases, including rare and neurological conditions. The development of generic versions could potentially improve access to these medicines and reduce treatment costs.
Dr. Wang Guoping, General Manager of the Yangzhou site, said this was the first FDA inspection of a generic oligonucleotide manufacturer. He added that Aurisco is working with regulatory agencies around the world to help establish development and manufacturing pathways for generic TIDES products.
TIDES is a term commonly used for oligonucleotide and peptide-based medicines. Aurisco operates as a global manufacturer of these products and provides contract development and manufacturing organization (CDMO) services, as well as generic API manufacturing.
The Yangzhou facility had previously undergone a USFDA inspection in 2023. The latest inspection further supports Aurisco’s efforts to expand its presence in the global pharmaceutical manufacturing market.
Dr. Li Jinliang, Board Director at Aurisco, said the inspection could mark the beginning of wider access to safe and affordable oligonucleotide medicines. He also thanked the company’s employees, customers and shareholders for their support.
The successful inspection comes as demand for oligonucleotide medicines continues to grow. Pharmaceutical companies are increasingly using these therapies because they can target specific biological processes involved in disease.
For Aurisco, the FDA inspection result strengthens its position as a manufacturer of oligonucleotide APIs and supports its plans to work with customers developing generic TIDES medicines. The company now expects its Yangzhou facility to play a greater role in supporting the global supply of generic oligonucleotide products.
The inspection does not itself mean that specific generic medicines have received FDA approval. However, the successful facility inspection represents an important regulatory step for Aurisco and could support future applications involving generic oligonucleotide APIs.