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2 clusters · 4 sources · 3 days · First seen · Last updated

Chinese CDMO regulatory inspection successes

Overview

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

Altruist Biologics announced that its commercial manufacturing facility in Suzhou, China, passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with “no critical findings.” This certification enables the company to begin manufacturing a biological product for an existing client and supports a European Union marketing authorization application. The company is also expanding its capacity through its Hangzhou site.

In a related development, WuXi Biologics reported that its Mashan facility completed a two-week unannounced GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection included several FDA-approved products, such as monoclonal antibodies and fusion proteins, reinforcing the company’s capacity to supply the U.S. market.

Entities

European Medicines Agency · Suzhou · WuXi Biologics · Innovent Biologics · Altruist Biologics

Timeline

  1. [BUSINESS] 2 sources
    Chinese CDMOs complete major FDA and EMA regulatory inspections

    Chinese CDMOs WuXi Biologics and Altruist Biologics have successfully passed GMP inspections by the FDA and EMA, respectively, strengthening their commercial biologics manufacturing capabilities.

  2. [BUSINESS] 2 sources
    Altruist Biologics receives EMA GMP certification for Suzhou facility

    Altruist Biologics' Suzhou facility in China has passed an EMA GMP inspection with no critical findings, enabling the production of biological products for an existing client.

Sources

bioprocessintl.com · genengnews.com · news.cube-soft.jp · prfire.com