Chinese CDMOs complete major FDA and EMA regulatory inspections

Chinese contract development and manufacturing organizations (CDMOs) have announced successful regulatory inspections by major international health authorities.

WuXi Biologics reported that its Mashan facility in China completed a two-week unannounced Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration (FDA). The inspection covered several FDA-approved products, including monoclonal antibodies and fusion proteins. The company stated this reinforces its ability to supply commercial products to the U.S. market.

Altruist Biologics announced that its Suzhou commercial manufacturing facility received GMP certification from the European Medicines Agency (EMA) with zero critical findings. This certification supports a European Union marketing authorization application for a client's biologics product. The company noted that its Suzhou and Hangzhou sites are designed to meet requirements for the EMA, FDA, Japan's PMDA, and China's NMPA.