Aurisco Yangzhou Site Passes FDA Inspection

Aurisco Pharmaceutical, a global Oligonucleotide and Peptide (TIDES) manufacturer, announced that its site in Yangzhou, China has passed a U.S. FDA inspection.

The FDA pre-approval inspection for Inclisiran Sodium inspection was carried out over 5 days as initially planned, and covered cGMP compliance inspection for oligonucleotides, GLP-1 peptides (such as Semaglutide and Tirzepatide) and small molecules.

Dr. Wang Guoping, site GM, calls this, “the first FDA inspection of a generic oligonucleotide manufacturer.”

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

According to Dr. Li Jinliang, Board Director, “This inspection marks the beginning of a new era of safe and affordable oligonucleotides for patients. I congratulate Aurisco’s team for being so committed and thank our customers and shareholders for their trust and support.”