Shanghai, China, August 12, 2026
Aurisco Pharmaceutical announced that its manufacturing site in Yangzhou, China, has successfully passed a U.S. Food and Drug Administration (USFDA) inspection, marking what the company describes as the first successful USFDA inspection of a generic oligonucleotide API manufacturer. The five-day pre-approval inspection, conducted from June 15 to 19, 2026, focused on manufacturing capabilities and current Good Manufacturing Practice (cGMP) compliance for oligonucleotides, GLP-1 peptides and small molecules. The milestone strengthens Aurisco’s position in complex generic medicines and supports the company’s efforts to establish global development pathways for generic TIDES therapies.
USFDA Inspection Highlights Aurisco’s cGMP Capabilities
The USFDA inspection was conducted in connection with Inclisiran Sodium and included an assessment of Aurisco’s Yangzhou manufacturing operations and quality systems. According to the company, the inspection covered cGMP compliance for oligonucleotides, GLP-1 peptides such as semaglutide and tirzepatide, and small-molecule products. The inspection also evaluated the site’s manufacturing facilities, documentation and organizational readiness. Following the inspection, the Establishment Inspection Report (EIR) confirmed that Aurisco had successfully addressed the inspectors’ observations through an approved Corrective and Preventive Action (CAPA) plan. The company said the inspector expressed satisfaction with its facilities and highlighted the strength of its GMP systems, documentation, inspection organization and technical team knowledge. The successful outcome represents an important quality and regulatory milestone for Aurisco as demand grows for complex pharmaceutical active ingredients and advanced therapeutic modalities.
Generic Oligonucleotides Expand Aurisco’s TIDES Strategy
Aurisco is a global manufacturer focused on oligonucleotide and peptide products, commonly grouped within the broader TIDES category. The successful USFDA inspection provides an important foundation for the company’s plans to expand its generic oligonucleotide capabilities and collaborate with regulatory agencies around the world to establish development and regulatory pathways for these complex products. The company said the inspection could open opportunities for future generic versions of several important oligonucleotide medicines, including inclisiran, vutrisiran, nusinersen and eplontersen. These therapies represent different applications of nucleic-acid-based medicines, highlighting the growing importance of specialized manufacturing capabilities for the development and supply of advanced pharmaceutical products. Aurisco’s Yangzhou facility had also successfully undergone a USFDA inspection in 2023 and provides CDMO services and generic API manufacturing.
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Regulatory Milestone Supports Global Pharmaceutical Manufacturing
The latest inspection is significant for the broader generic oligonucleotide manufacturing sector, where complex chemistry, analytical control and stringent quality requirements are important considerations for regulatory approval and commercial supply. The FDA has separately issued guidance addressing clinical pharmacology considerations for the development of oligonucleotide therapeutics, reflecting the specialized regulatory framework surrounding this emerging class of medicines. For Aurisco, the successful inspection reinforces its focus on quality, regulatory compliance and complex pharmaceutical manufacturing. The company operates multiple R&D and manufacturing facilities and serves international pharmaceutical markets through its API, finished-dose and CDMO capabilities. The Yangzhou inspection outcome could also strengthen its ability to support customers developing and commercializing generic TIDES products in global markets. The milestone comes as pharmaceutical developers increasingly explore oligonucleotide medicines and peptide therapeutics for chronic and rare diseases. By demonstrating compliance with USFDA expectations across complex manufacturing operations, Aurisco aims to strengthen its role in supplying high-quality and potentially more affordable generic medicines. The company said the inspection marks an important step toward expanding access to safe and affordable oligonucleotide therapies and advancing global opportunities for generic TIDES manufacturing.
Source: Aurisco Pharmaceutical press release
