ANVISA GMP Certification Achieved

Nitto Avecia’s Milford, Massachusetts manufacturing site has earned Good Manufacturing Practice (GMP) Certification from ANVISA, Brazil’s national health regulatory agency, for the production of Eplontersen sodium. The certification — valid through July 21, 2027 — confirms full compliance with both Brazilian regulatory requirements and World Health Organization (WHO) standards.

This milestone reflects Nitto Avecia’s commitment to quality, safety, and operational excellence in oligonucleotide therapeutics manufacturing, and opens the door to one of the world’s most stringent pharmaceutical markets. The achievement is a direct result of cross-departmental collaboration between the company’s Quality and Regulatory Compliance teams.