Aurisco Pharmaceutical is the First Generic Oligonucleotide Manufacturer in the World successfully inspected by USFDA
SHANGHAI, Aug. 12, 2026 /PRNewswire/ -- Aurisco Pharmaceutical, a leading global Oligonucleotide and Peptide (TIDES) manufacturer, announced today that its site in Yangzhou, China has passed the USFDA inspection as the first generic Oligonucleotide API manufacturer in the world.
The USFDA pre-approval inspection for Inclisiran Sodium inspection was carried out for 5 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 Aurisco successfully addressed the inspector's observations with an approved CAPA plan. 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.
Dr. Wang Guoping, site GM, said "This was the first FDA inspection to a generic oligonucleotide manufacturer. We are collaborating with agencies worldwide to establish pathways for generic TIDES". This inspection opens the door for future generic oligonucleotides (Inclisiran, Vutrisiran, Nusinersen, Eplontersen, etc.). The site had been successfully inspected by USFDA in 2023 and offers CDMO services and generic APIs.
Dr. Li Jinliang, Board Director, said "This inspection marks the beginning of a new of safe and affordable oligonucleotides patients. I congratulate Aurisco's team for being so committed and thank our customers and shareholders for their trust and support."
About Aurisco
Aurisco Pharmaceutical Co., Ltd. (SSE: 605116) serves global markets since 1998. With 6 R&D centers, 4 manufacturing sites and sales offices in USA, Portugal, India and Brazil, the company focuses on complex products. With 100+ patents filled worldwide and 300 scientists, the company offers an IP safe and a cGMP and ESG compliant environment for NCEs and complex generics.
Being Ecovadis Gold ranked, Aurisco has joined the SBTi, M2030 and the SPP. Aurisco passed RX360 supply chain security inspection and has been audited by the Pharmaceutical Supply Chain Initiative (PSCI).
For further information, please visit www.aurisco.com and follow us on LinkedIn or contact info@aurisco.com.
Contact: Rafael Antunes, rafael@aurisco.com, M. +351 919 387 143
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