Oligonucleotide and peptide (TIDES) manufacturer Aurisco Pharmaceutical Co Ltd (SSE:605116) announced on Wednesday that its site in Yangzhou, China has passed US FDA inspection as the first generic oligonucleotide API manufacturer in the world.

The pre-approval inspection for Inclisiran Sodium was carried out for five days (15-19 Jun 2026), as initially planned, and covered cGMP compliance inspection for oligonucleotides, GLP-1 peptides (such as semaglutide and tirzepatide) and small molecules.

The EIR letter confirmed that Aurisco successfully addressed the inspector's observations with an approved CAPA plan. The company says that the inspector was satisfied with the facilities, and complimented Aurisco on its GMP system and documents, inspection organisation and the knowledge of its team members.