The US FDA has completed a pre-approval inspection of Aurisco Pharmaceutical’s Yangzhou site covering generic oligonucleotide manufacturing, including Inclisiran Sodium.

The five-day inspection, conducted from 15 to 19 June 2026, examined cGMP compliance across oligonucleotides, GLP-1 peptides including semaglutide and tirzepatide, and small molecules.

Aurisco said the inspection was successfully closed following submission of an approved corrective and preventive action (CAPA) plan addressing the inspector’s observations.

The company said the inspection was the first US FDA inspection of a manufacturing site specifically for generic oligonucleotides. Aurisco’s Yangzhou facility had previously undergone a US FDA inspection in 2023.

Inspection covers generic oligonucleotide API

The inspection focused in part on Inclisiran Sodium, an oligonucleotide API used in the development of generic versions of inclisiran.

Aurisco said the US FDA inspector was satisfied with the site’s facilities and quality systems and complimented the company’s GMP documentation, inspection organisation and technical knowledge.

The company has been developing generic oligonucleotide APIs and has previously identified inclisiran, nusinersen and vutrisiran among its generic oligonucleotide programmes.

Aurisco has also filed a US Drug Master File for vutrisiran, while its US Drug Master File for Inclisiran Sodium is listed as active.

The regulatory milestone comes as manufacturers and developers work towards expanding access to complex oligonucleotide medicines, which can present different manufacturing and analytical challenges from conventional small-molecule generics.

Aurisco plans further generic oligonucleotide development

Wang Guoping, site general manager at Aurisco, said: “This was the first FDA inspection to a generic oligonucleotide manufacturer. We are collaborating with agencies worldwide to establish pathways for generic TIDES.”

He added that the inspection could support future generic oligonucleotide programmes involving medicines including inclisiran, vutrisiran, nusinersen and eplontersen.

Aurisco’s Yangzhou operation provides API manufacturing and CDMO services for oligonucleotides, peptides and small molecules.

The company has been expanding its oligonucleotide manufacturing capabilities for several years. In 2023, Aurisco announced additional cGMP oligonucleotide manufacturing capacity at its facilities, including a solid-phase synthesis system designed to support clinical and commercial programmes.

Generic access to complex medicines

The inspection is relevant to the wider development of generic versions of oligonucleotide medicines, several of which are already used to treat serious or chronic diseases.

Aurisco has previously worked on generic oligonucleotide drug substance programmes, including a Brazilian project involving nusinersen for spinal muscular atrophy. The project is intended to support development of a national manufacturing platform for RNA oligonucleotide medicines in Brazil.

Li Jinliang, board director at Aurisco, said: “This inspection marks the beginning of a new of safe and affordable oligonucleotides patients.”

The company said the successful inspection provides a regulatory milestone for its generic oligonucleotide manufacturing activities and could support further development of APIs for the US market.