Aurisco Pharmaceutical has announced that its manufacturing site in Yangzhou, China, has successfully completed a US Food and Drug Administration (FDA) inspection, making it the first generic oligonucleotide active pharmaceutical ingredient (API) manufacturer to pass a US FDA inspection, according to the company.

The five-day pre-approval inspection for inclisiran sodium took place from 15 to 19 June 2026. The inspection assessed compliance with current good manufacturing practice (cGMP) requirements covering oligonucleotides, GLP-1 peptides, including semaglutide and tirzepatide, and small-molecule medicines.

Following the inspection, the FDA's Establishment Inspection Report (EIR) confirmed that Aurisco had addressed the observations raised during the inspection through an approved corrective and preventive action (CAPA) plan.

The inspection also covered the site's manufacturing facilities, quality systems, documentation, inspection procedures and staff capabilities. Aurisco said the FDA inspectors were satisfied with the site's facilities and GMP systems.

The successful inspection supports Aurisco's plans to expand its generic oligonucleotide manufacturing capabilities and develop pathways for future generic TIDES products. Potential products include inclisiran, vutrisiran, nusinersen and eplontersen.

Aurisco's Yangzhou site previously completed a US FDA inspection in 2023. The facility provides contract development and manufacturing organisation (CDMO) services and produces generic APIs.

The latest inspection marks a further step in Aurisco's plans to support the development and manufacture of generic oligonucleotide medicines and improve access to these treatments.

 

Source: prnewswire.com

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