AGC Biologics Secures GMP Certification from Brazil's Anvisa

Enables Supply to Brazil's Largest Pharmaceutical Market

Published on Feb. 23, 2026

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AGC Biologics, a subsidiary of AGC Inc., has obtained Good Manufacturing Practice (GMP) certification from Brazil's National Health Surveillance Agency (Anvisa) for its Seattle site. This certification allows biopharmaceutical products manufactured at the Seattle facility to be supplied to Brazil, the largest pharmaceutical market in South America.

Why it matters

This certification expands AGC Biologics' global reach and strengthens the company's ability to provide high-quality CDMO services for pharmaceutical and agricultural applications worldwide. It aligns with AGC's medium-term management plan to contribute to safe, secure, and healthy living by ensuring the stable supply of essential products and services.

The details

The Seattle site has over 30 years of experience in the development and manufacturing of biopharmaceuticals based on mammalian and microbial systems. In 2025, the site successfully passed all external audits and achieved a 100% batch success rate. With this latest certification, the number of countries in which products manufactured at the Seattle site have obtained regulatory approval has reached more than 11.

  • AGC Biologics obtained GMP certification from Brazil's Anvisa in February 2026.
  • The Seattle site successfully passed all external audits and achieved a 100% batch success rate in 2025.

The players

AGC Biologics, Inc.

A biopharmaceutical CDMO subsidiary of AGC Inc., headquartered in Washington State, USA.

AGC Inc.

A Japanese multinational corporation that has identified three areas of social value, including contributing to safe, secure, and healthy living through its Life Science business.

Anvisa

Brazil's National Health Surveillance Agency, which has certified the GMP compliance of AGC Biologics' Seattle site.

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What’s next

With this latest certification, AGC Biologics can now supply biopharmaceutical products manufactured at its Seattle facility to the Brazilian market, the largest pharmaceutical market in South America.

The takeaway

This GMP certification from Brazil's Anvisa is a significant milestone for AGC Biologics, as it expands the company's global reach and strengthens its ability to provide high-quality CDMO services to the pharmaceutical and agricultural industries worldwide.