Aurisco Pharmaceutical said its Yangzhou, China manufacturing site has passed an FDA pre-approval inspection for inclisiran sodium, describing the facility as the first generic oligonucleotide active pharmaceutical ingredient manufacturer in the world to complete such an inspection.
The five-day inspection took place from June 15 through June 19 and covered current good manufacturing practice compliance for oligonucleotides, GLP-1 peptides including semaglutide and tirzepatide, and small-molecule products.
Aurisco said the FDA’s Establishment Inspection Report confirmed that the company had successfully addressed the inspector’s observations through an approved corrective and preventive action plan. The company said the inspector was satisfied with the facility and complimented its GMP system and documentation, inspection organization and the knowledge of team members.
Dr. Wang Guoping, general manager of the Yangzhou site, said the inspection was the first FDA inspection of a generic oligonucleotide manufacturer. He said Aurisco is collaborating with regulatory agencies worldwide to help establish development and regulatory pathways for generic TIDES, a category that includes peptides and oligonucleotides.
The inspection is expected to support Aurisco’s plans for future generic oligonucleotide products, including potential versions of inclisiran, vutrisiran, nusinersen and eplontersen. The Yangzhou site was previously inspected by FDA in 2023 and provides contract development and manufacturing services as well as generic active pharmaceutical ingredients.
Aurisco said the latest inspection is an important milestone in its effort to expand access to oligonucleotide medicines. The company manufactures oligonucleotides and peptides, often grouped as TIDES therapies, and operates in the broader market for active pharmaceutical ingredients and contract manufacturing.
Board Director Dr. Li Jinliang said the result marks the beginning of what he described as a new era of safe and affordable oligonucleotide medicines for patients. He credited the company’s team for its commitment and thanked customers and shareholders for their support.
Aurisco said the outcome reinforces its quality systems and manufacturing capabilities as it prepares to support the development of generic oligonucleotide therapies for global markets. The company did not provide a timetable for regulatory filings or commercial availability of any prospective generic products.