AGC Biologics’ Seattle manufacturing facility has received Good Manufacturing Practices (GMP) certification from Brazil’s health regulatory authority, Agência Nacional de Vigilância Sanitária, enabling biologics and biosimilars produced at the site to be commercialized in Brazil.
The certification allows customers to access Brazil’s $40 billion pharmaceutical market and builds on the site’s regulatory track record, including a September 2025 U.S. Food and Drug Administration Establishment Inspection Report confirming full compliance with current GMP requirements. AGC Biologics’ Seattle site is now recognized as cGMP certified across 11 countries and recently completed 11 customer audits, achieved ISO 45001 and ISO 14001 certifications with no non-conformities, and reported a 100% batch success rate. “This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market,” said Marty Shawala, Senior Vice President, Quality, AGC Biologics.
As the company’s 150,000 square foot Seattle campus expands its global regulatory footprint, the certification strengthens the region’s role as a launch point for international biologics manufacturing and market access.