The inspection specifically evaluated the production of Inclisiran Sodium, setting a regulatory precedent for the manufacturing of complex generic drugs. According to the Establishment Inspection Report, Aurisco addressed all inspector observations through an approved corrective and preventive action plan. Auditors praised the facility’s GMP documentation, organizational rigor, and the technical proficiency of the team.
Aurisco Clears Landmark USFDA Inspection for Generic Oligonucleotides
Aurisco Pharmaceutical has become the world’s first generic oligonucleotide manufacturer to pass a USFDA inspection, successfully clearing a pre-approval assessment at its Yangzhou facility. The five-day audit, conducted in June 2026, confirms the site's compliance with cGMP standards for oligonucleotides, GLP-1 peptides, and small molecules.
Dr. Wang Guoping, the site’s general manager, noted that this milestone provides a blueprint for collaborating with global agencies on future generic TIDES products. The successful review clears a path for the commercialization of various generic oligonucleotides, including Vutrisiran, Nusinersen, and Eplontersen. This follows a previous successful USFDA inspection in 2023, reinforcing the company's position as both a CDMO provider and a source for generic APIs. Board Director Dr. Li Jinliang stated that this achievement is a critical step toward increasing the availability of safe and affordable treatments for patients worldwide.
Comments (0)
No comments yet. Be the first!