Authorization clears the way for customers to enter Brazil’s $40 billion pharmaceutical market
SEATTLE – February 3, 2026 – The Seattle facility of AGC Biologics, your friendly CDMO expert, has received a Good Manufacturing Practices Certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s health regulatory authority. The authorization allows biologics and biosimilars produced at the site to be commercialized in Brazil, the largest pharmaceutical market in South America, further extending the global reach of AGC Biologics’ customers.
“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. “It reflects how our teams work collaboratively across departments and throughout the network to meet required quality standards and maintaining the business strategy associated with our customer’s regulatory submission.”
According to a report from Fortune Business Insights, Brazil’s pharmaceutical market is poised to grow to nearly $74 billion in 2032, with biologics and biosimilars representing 40% of the market in 2024.
A consistent global quality record
This achievement underscores AGC Biologics' commitment to maintaining a consistent, global quality record that helps partners secure regulatory approval in key markets.
- In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming the Seattle site's full cGMP compliance.
- The Seattle site is now a cGMP-certified facility in 11 different countries, demonstrating its ability to meet diverse international standards.
- Seattle is the second manufacturing facility in the AGC Biologics network to receive GMP certification from Anvisa, with the Copenhagen site receiving GMP certification from the agency in 2023. This shared approval status can facilitate tech transfers between sites when needed.
In 2025, the Seattle facility completed:
- 11 successful customer audits
- ISO 45001 and ISO 14001 certification audits with zero non-conformities
- a 100% batch success rate
AGC Biologics achieves these regulatory and production milestones with a cohesive global quality system built on harmonized documentation, regulatory expertise, and best-practice sharing between sister sites.
Company focused on delivering additional regulatory approvals for customers
“With every inspection, our team becomes more prepared for the next, and this Anvisa certification is a testament to that momentum as well as the strength of our global quality systems,” said Kathleen Retzloff, Senior Director of Quality for AGC Biologics’ Seattle site. “We are laser-focused on helping our customers achieve even more regulatory success in the year ahead.”
The 150,000-square-foot uniflow campus in Seattle supports flexible fed-batch and perfusion processes and serves as AGC Biologics’ Center of Excellence for global formulation services. With extensive adoption of single-use technologies and adherence to current ICH guidelines, the Seattle site of AGC Biologics ensures rapid scale-up from clinical to commercial supply while maintaining robust cGMP compliance.
