Aurisco Pharmaceutical Passes USFDA Inspection as First Generic Oligonucleotide Manufacturer

Aurisco Pharmaceutical announced it has become the first generic oligonucleotide active pharmaceutical ingredient (API) manufacturer to pass a USFDA inspection. The inspection took place at Aurisco's facility in Yangzhou, China, from June 15 to 19, 2026. The USFDA's evaluation included a pre-approval inspection for Inclisiran Sodium and a review of the facility's compliance with current good manufacturing practices (cGMP) for oligonucleotides, peptides, and small molecules.

The inspector expressed satisfaction with Aurisco's capabilities, including its GMP system, documents, and team knowledge. Dr. Wang Guoping, Aurisco's site General Manager, emphasized the inspection as a significant milestone for the company and the generic TIDES sector. Board Director Dr. Li Jinliang highlighted the opening of new pathways for safe and affordable oligonucleotides.