Aurisco Pharmaceutical Leads as the First Generic Oligonucleotide Manufacturer Inspected by USFDA
In a groundbreaking development, Aurisco Pharmaceutical has made history by becoming the first generic oligonucleotide manufacturer globally to pass an inspection conducted by the U.S. Food and Drug Administration (USFDA). The company's state-of-the-art facility located in Yangzhou, China, underwent rigorous scrutiny over five days from June 15 to June 19, 2026, during which compliance with current Good Manufacturing Practices (cGMP) was thoroughly evaluated.
This inspection was pivotal for Aurisco, as it specifically targeted the manufacturing of Inclisiran Sodium, marking a crucial turning point for the production of oligonucleotides in the generic pharmaceutical landscape. Oligonucleotides, which are short DNA or RNA molecules, have become essential in the treatment of various health conditions, including genetic disorders, cancer, and viral infections. With the successful completion of this inspection, Aurisco is poised to expand its operations significantly in this critical sector.
Dr. Wang Guoping, General Manager of the Yangzhou site, expressed enthusiasm about this achievement, stating, ; " ;This inspection marks the first time a generic oligonucleotide manufacturer has been under FDA scrutiny. Our successful outcome sets the stage for future collaborations with global regulatory agencies to ensure pathways for generic TIDES (Oligonucleotide and Peptide). This achievement will pave the way for the introduction of various generic oligonucleotides, including Inclisiran, Vutrisiran, Nusinersen, and Eplontersen, that will provide more affordable treatments for patients.
The FDA inspection process included assessing the cGMP compliance in the production of both oligonucleotides and GLP-1 peptides such as Semaglutide and Tirzepatide. Remarkably, the inspector commended Aurisco's facilities, the organization's ability to address the inspector's observations, and the robust knowledge demonstrated by the team members during the inspection. The successful completion of the inspection has been captured in an Establishment Inspection Report (EIR), which confirms Aurisco's adherence to the stringent requirements set forth by the USFDA.
Dr. Li Jinliang, Board Director of Aurisco, highlighted the significance of this achievement for patient care. He noted, ; " ;This FDA inspection is not just a milestone for our company, but symbolizes the beginning of a new era for safe and affordable oligonucleotide treatments globally. I want to congratulate our dedicated team and express gratitude to our customers and shareholders for their unwavering trust and support.
Aurisco Pharmaceutical is no stranger to innovation in the biotechnology field. Established in 1998, the company operates six research and development centers and four manufacturing sites, serving a global market with offices in the USA, Portugal, India, and Brazil. Over the years, Aurisco has filed more than 100 patents across the globe and brings together a team of over 300 scientists dedicated to pioneering complex products in an Intellectual Property (IP) safe environment. The organization adheres to cGMP and Environmental Social Governance (ESG) standards, contributing to a more sustainable pharmaceutical landscape.
Aurisco's commitment to safety and quality was recently exemplified when they completed an RX360 supply chain security inspection and have been audited by the Pharmaceutical Supply Chain Initiative (PSCI). Furthermore, the company is recognized by EcoVadis with a Gold rating, showcasing its commitment to sustainable practices. Aurisco is also actively participating in initiatives such as the Science Based Targets initiative (SBTi), the M2030 initiative, and the Sustainable Pharmaceutical Principles (SPP).
As Aurisco Pharmaceutical celebrates this groundbreaking accomplishment, the industry watches closely for the potential insights and innovations the company will be able to bring to the market. With ongoing efforts to collaborate with regulatory bodies and advance the landscape of generic oligonucleotide products, the future looks promising for both Aurisco and the broader pharmaceutical community.
This inspection was pivotal for Aurisco, as it specifically targeted the manufacturing of Inclisiran Sodium, marking a crucial turning point for the production of oligonucleotides in the generic pharmaceutical landscape. Oligonucleotides, which are short DNA or RNA molecules, have become essential in the treatment of various health conditions, including genetic disorders, cancer, and viral infections. With the successful completion of this inspection, Aurisco is poised to expand its operations significantly in this critical sector.
Dr. Wang Guoping, General Manager of the Yangzhou site, expressed enthusiasm about this achievement, stating, ; " ;This inspection marks the first time a generic oligonucleotide manufacturer has been under FDA scrutiny. Our successful outcome sets the stage for future collaborations with global regulatory agencies to ensure pathways for generic TIDES (Oligonucleotide and Peptide). This achievement will pave the way for the introduction of various generic oligonucleotides, including Inclisiran, Vutrisiran, Nusinersen, and Eplontersen, that will provide more affordable treatments for patients.
The FDA inspection process included assessing the cGMP compliance in the production of both oligonucleotides and GLP-1 peptides such as Semaglutide and Tirzepatide. Remarkably, the inspector commended Aurisco's facilities, the organization's ability to address the inspector's observations, and the robust knowledge demonstrated by the team members during the inspection. The successful completion of the inspection has been captured in an Establishment Inspection Report (EIR), which confirms Aurisco's adherence to the stringent requirements set forth by the USFDA.
Dr. Li Jinliang, Board Director of Aurisco, highlighted the significance of this achievement for patient care. He noted, ; " ;This FDA inspection is not just a milestone for our company, but symbolizes the beginning of a new era for safe and affordable oligonucleotide treatments globally. I want to congratulate our dedicated team and express gratitude to our customers and shareholders for their unwavering trust and support.
Aurisco Pharmaceutical is no stranger to innovation in the biotechnology field. Established in 1998, the company operates six research and development centers and four manufacturing sites, serving a global market with offices in the USA, Portugal, India, and Brazil. Over the years, Aurisco has filed more than 100 patents across the globe and brings together a team of over 300 scientists dedicated to pioneering complex products in an Intellectual Property (IP) safe environment. The organization adheres to cGMP and Environmental Social Governance (ESG) standards, contributing to a more sustainable pharmaceutical landscape.
Aurisco's commitment to safety and quality was recently exemplified when they completed an RX360 supply chain security inspection and have been audited by the Pharmaceutical Supply Chain Initiative (PSCI). Furthermore, the company is recognized by EcoVadis with a Gold rating, showcasing its commitment to sustainable practices. Aurisco is also actively participating in initiatives such as the Science Based Targets initiative (SBTi), the M2030 initiative, and the Sustainable Pharmaceutical Principles (SPP).
As Aurisco Pharmaceutical celebrates this groundbreaking accomplishment, the industry watches closely for the potential insights and innovations the company will be able to bring to the market. With ongoing efforts to collaborate with regulatory bodies and advance the landscape of generic oligonucleotide products, the future looks promising for both Aurisco and the broader pharmaceutical community.
Topics Health）
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