Aurisco, the first USFDA inspected generic oligonucleotide API manufacturer is innovating in enzymatic ligation, hybrid solid and liquid phase synthesis, GLP-1 peptide recombinant and SPPS technologies, flow-photochemistry and much more.
Aurisco Pharmaceutical, a leading global oligonucleotide and peptide (TIDES) and small molecule API manufacturer, recently announced that its site in Yangzhou, China has passed the USFDA inspection this June as the first generic Oligonucleotide API manufacturer in the world. The USFDA preapproval inspection for Inclisiran Sodium API covered cGMP compliance inspection for oligonucleotides, GLP-1 peptides.
A New Era in Oligonucleotides
Aurisco’s announcement marks more than a corporate milestone; it signals a new era for oligonucleotides. As of August 25, 2026, FDA had approved 24 oligonucleotide medicines, including 12 ASOs and 8 siRNAs, yet no generic oligonucleotide had been approved in the US. However, Paragraph IV competition is intensifying: Leqvio (inclisiran) has one ANDA filed, alongside two Spinraza (nusinersen) ANDAs and one Amvuttra (vutrisiran) ANDA. Generic oligonucleotides are moving closer to US patients.
Oligonucleotides are short, synthetic DNA or RNA strands designed to bind specific genetic sequences and regulate gene expression. Antisense oligonucleotides (ASOs) bind targeted RNA to modify its processing or function, whereas small interfering RNAs (siRNAs) promote RNA degradation and gene silencing. GalNAc conjugation enables efficient, targeted delivery to liver cells. Their sequencebased mechanisms make oligonucleotides a powerful therapeutic platform for genetic and rare disorders, as well as increasingly prevalent diseases.
