- First company in China to receive GMP certification for the production of biologics from the U.S. FDA, EMA and ANVISA
Wuxi, CHINA, December 28, 2020 – WuXi Biologics (WuXi Bio) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has received the Good Manufacturing Practice (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA). The positive assessment from ANVISA reaffirms WuXi Biologics’ strong commitment to offering partners a global manufacturing network of the highest standard.
This is WuXi Biologics’ third GMP certification from drug regulatory authorities, and distinguishes it as the first company in China to receive authorizations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and ANVISA to manufacture biologics. 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,” commented Dr. 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.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.