#China #Yangzhou #Oligonucleotides #Aurisco Pharmaceutical #USFDA

Aurisco Pharmaceutical Sets a New Standard in Oligonucleotide Manufacturing

In a significant breakthrough for the pharmaceutical industry, Aurisco Pharmaceutical has announced that its plant located in Yangzhou, China has successfully passed an inspection by the US Food and Drug Administration (USFDA). This achievement makes Aurisco the first global manufacturer of generic oligonucleotides to receive this critical approval, a milestone that promises to enhance patient access to vital medications based on these innovative compounds.

The USFDA's pre-marketing inspection of Aurisco's operations took place over five days, from June 15 to June 19, 2026. This comprehensive review focused on the facility's compliance with Current Good Manufacturing Practices (cGMP) specifically for oligonucleotides, GLP-1 peptides like semaglutide and tirzepatide, as well as for small molecule drugs. The inspection was conducted rigorously to ensure that Aurisco meets the highest safety and quality standards crucial for public health.

Dr. Wang Guoping, the General Manager of the Yangzhou facility, highlighted the significance of this inspection, stating, "This was the first time the USFDA inspected a generic oligonucleotide manufacturer. We are dedicated to collaborating with various agencies worldwide to establish channels for generic TIDES products. This inspection unambiguously paves the way for future generic oligonucleotides, including key products such as Inclisiran, Vutrisiran, and Nusinersen."

The successful inspection followed a promising review from the USFDA conducted in 2023, signaling a strong foundation for Aurisco's operations. It aligns with the company’s commitment to not only developing innovative drugs but also providing them at an affordable price point. In today's healthcare landscape, where the prices of medications can be prohibitively high, Aurisco’s advance into the generic oligonucleotide market serves as a beacon of hope for patients in need.

Moreover, the Environmental Impact Review (EIR) conducted during the inspection confirmed that Aurisco had effectively addressed the inspector's comments through an approved Corrective and Preventive Action (CAPA) plan. The inspector expressed satisfaction with the facility’s operations, commending Aurisco for its robust cGMP system, documentation, and inspection organization, along with the competencies demonstrated by the team members.

Dr. Li Jinliang, a board member at Aurisco, enthusiastically stated, "This inspection marks the beginning of a new era for patients who will benefit from safe and affordable oligonucleotides. I would like to extend my congratulations to the Aurisco team for their steadfast commitment and express our gratitude to our clients and shareholders for their trust and support."

Founded in 1998, Aurisco Pharmaceutical Co., Ltd. has established a prominent presence in the global market with six research and development centers and four production sites across the United States, Portugal, India, and Brazil. The company specializes in the production of complex pharmaceutical products, holding over 100 patents worldwide. Furthermore, Aurisco boasts a dedicated team of 300 scientists, offering a secure intellectual property environment that complies with stringent regulatory standards.

With recognition from the Ecovadis Gold certification and membership in various international initiatives, such as the Science Based Targets Initiative (SBTi) and the Pharmaceutical Supply Chain Initiative (PSCI), Aurisco is committed to sustainable practices and financial stability throughout its supply chains.

As the pharmaceutical landscape continues to evolve, Aurisco Pharmaceutical stands at the forefront, equipped to advance healthcare outcomes by merging cutting-edge science with manufacturing excellence. For more information about Aurisco, you can visit their official website or follow their updates on LinkedIn. Be sure to stay tuned as this dynamic company continues to drive innovation in the health sciences sector.