WuXi Biologics obtained Good Manufacturing Practice (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA). This is WuXi’s third GMP certification from drug regulatory authorities, and distinguishes it as the first company in China to receive authorizations from the FDA, European Medicines Agency (EMA), and ANVISA to manufacture biologics, according to the company.
To date, WuXi Biologics’ facilities in Wuxi city, Shanghai and Suzhou have passed a total of six GMP inspections conducted by these regulatory agencies.
“We are very excited to have reached another regulatory milestone during this challenging year. This achievement once again demonstrates WuXi Biologics’ high-quality services, which have been widely recognized by regulatory authorities. We owe this achievement to our partners’ trust in our capabilities and our team’s tireless commitment to excellence,” notes Chris Chen, CEO of WuXi Biologics.
“As outsourcing demand increases around the world, we have made huge strides in expanding our services globally and plan to increase our total biomanufacturing capacity to 300,000 liters after 2023. WuXi Biologics will continue to enable our global partners throughout the development and manufacturing process to provide life-saving treatments to patients worldwide.”