#China #Yangzhou #Oligonucleotide #Aurisco Pharmaceutical #USFDA

Aurisco Pharmaceutical's Historic Achievement

Aurisco Pharmaceutical has recently achieved a significant milestone, becoming the world's first generic oligonucleotide manufacturer to successfully pass inspection by the USFDA. This remarkable feat was accomplished at their facility located in Yangzhou, China, during an inspection that took place from June 15 to June 19, 2026. The assessment focused on the compliance with current Good Manufacturing Practices (cGMP) for oligonucleotides, GLP-1 peptides, and small molecules.

During the five-day inspection, the team at Aurisco demonstrated high levels of compliance and proficiency, which was noted positively by the inspectors. An Establishment Inspection Report (EIR) was issued, confirming that Aurisco had effectively addressed all observations raised during the inspection with an approved Corrective and Preventive Action (CAPA) plan. The inspection team praised the site’s facilities, documentation, industry-standard GMP practices, and the expertise of the Aurisco personnel involved.

Dr. Wang Guoping, General Manager of the Yangzhou site, expressed enthusiasm about this groundbreaking inspection, stating, "This was the first FDA inspection of a generic oligonucleotide manufacturer. We are working with agencies across the globe to pave the way for generic TIDES products." This inspection not only validates Aurisco's commitment to quality and compliance but also opens up opportunities for the approval of future generic oligonucleotide products, such as Inclisiran, Vutrisiran, Nusinersen, and Eplontersen.

In earlier instances, the Yangzhou facility had already passed another USFDA inspection in 2023, which further solidifies its standing in the market. The company offers Contract Development and Manufacturing Organization (CDMO) services alongside generic Active Pharmaceutical Ingredients (APIs) for its clients.

Dr. Li Jinliang, a board director at Aurisco, remarked, "This inspection signifies a monumental step towards providing safe and affordable oligonucleotide therapies for patients. I thank our committed team and express gratitude to our clients and shareholders for their unwavering support and trust in our capabilities."

Founded in 1998, Aurisco Pharmaceutical Co., Ltd. (SSE 605116) has long focused on complex products, serving global markets with a strong emphasis on innovation and safety. The company operates six research and development centers, four manufacturing facilities, and sales offices in countries such as the USA, Portugal, India, and Brazil. It prides itself on holding over 100 patents worldwide and has a workforce of 300 scientists.

Aurisco's commitment to maintaining an Intellectual Property (IP) safe and cGMP compliant environment enables it to cater to New Chemical Entities (NCEs) and complex generics effectively. Recognized for its environmental, social, and governance (ESG) initiatives, Aurisco received the Gold ranking from EcoVadis and is actively engaged with organizations like the Science Based Targets initiative (SBTi) and the M2030 initiative.

Such advancements underline the pharmaceutical giant's dedication to revolutionizing the space of oligonucleotide manufacturing. With successful inspections and rigorous standards in place, Aurisco Pharmaceutical continues to set the pace for others in the industry.

For further details about Aurisco and its range of products and services, visit www.aurisco.com. You can also connect through LinkedIn or contact them via email.