Shanghai, China, August 14, 2026
Aurisco Pharmaceutical announced that its Yangzhou, China manufacturing facility has successfully completed a U.S. Food and Drug Administration (FDA) inspection, marking a significant milestone for the company’s development of generic oligonucleotide active pharmaceutical ingredients (APIs). The five-day inspection, conducted from June 15 to June 19, 2026, focused on the facility’s compliance with current Good Manufacturing Practice (cGMP) requirements covering oligonucleotides, GLP-1 peptides, including semaglutide and tirzepatide, and small-molecule manufacturing. The successful inspection strengthens Aurisco’s position in the global complex-generics and TIDES manufacturing sector and could support the company’s efforts to expand access to generic oligonucleotide products.
FDA Inspection Evaluates cGMP Manufacturing Systems
The FDA conducted the inspection as a pre-market inspection related to Inclisiran Sodium, while also assessing manufacturing operations and quality systems associated with several complex pharmaceutical product categories. According to Aurisco, the inspection evaluated cGMP compliance for oligonucleotides, GLP-1 peptides, and small molecules, placing particular emphasis on the facility’s manufacturing processes, documentation, and quality-management systems. Aurisco reported that the inspection findings were addressed through an approved Corrective and Preventive Action (CAPA) plan. The company’s Environmental Impact Assessment (EIR) report confirmed that the inspector’s observations had been addressed, and Aurisco said the inspector expressed satisfaction with the facility, its GMP system and documentation, the organization of the inspection, and the capabilities of its personnel. The outcome represents an important quality and regulatory milestone for a facility manufacturing complex pharmaceutical APIs for international markets.
Aurisco Expands Generic Oligonucleotide Capabilities
Aurisco described the inspection as a significant development for the emerging generic oligonucleotide manufacturing sector. The company said its Yangzhou facility is positioned to support future development of generic TIDES products, including Inclisiran, Vutrisiran, Nusinersen, and Eplontersen. Oligonucleotide medicines are increasingly important in the treatment of genetic and other complex diseases, but their manufacturing can involve sophisticated processes and specialized quality controls. The successful FDA inspection also builds on the facility’s previous regulatory experience. Aurisco said the Yangzhou site underwent a conclusive FDA inspection in 2023 and provides both contract development and manufacturing organization (CDMO) services and generic active pharmaceutical ingredients. The latest inspection further demonstrates the company’s efforts to maintain manufacturing systems capable of meeting international regulatory expectations for complex pharmaceutical products. Aurisco’s focus extends beyond oligonucleotides to other complex products, including GLP-1 peptides and small molecules. This broader manufacturing capability may allow the company to serve pharmaceutical partners across multiple therapeutic and product categories while maintaining a focus on complex generics and TIDES technologies.
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Strengthening Global cGMP Manufacturing Infrastructure
Founded in 1998, Aurisco Pharmaceutical operates an international R&D and manufacturing network that includes six R&D centers and four production sites, along with commercial offices in the United States, Portugal, India, and Brazil. The company said it has more than 300 scientists and over 100 patents filed worldwide, supporting its activities in complex pharmaceutical development and manufacturing. The latest FDA inspection outcome is particularly relevant to the global pharmaceutical supply chain because regulatory-compliant manufacturing is essential for the development and commercialization of generic medicines. Demonstrated compliance with cGMP standards, quality systems, documentation requirements, and CAPA processes can help manufacturers establish confidence among regulatory agencies and pharmaceutical partners.
Aurisco said the successful inspection could pave the way for further development of generic oligonucleotide APIs, potentially supporting broader availability of complex medicines and strengthening manufacturing competition in the TIDES sector. The company also highlighted its existing quality and supply-chain credentials, including participation in industry supply-chain and sustainability initiatives. For the pharmaceutical manufacturing industry, Aurisco’s FDA inspection outcome underscores the growing importance of specialized cGMP infrastructure for oligonucleotides and complex generics. As demand for advanced medicines continues to grow, manufacturers capable of meeting stringent regulatory and quality requirements will play an increasingly important role in global pharmaceutical supply chains.
Source: Aurisco Pharmaceutical press release
