Boehringer Ingelheim’s Shanghai Unit Secures EMA and FDA Approval for Biopharmaceutical Supply

Germany-based Boehringer Ingelheim has announced that its Shanghai-based Contract Manufacturing Organization (CMO), Boehringer Ingelheim Biopharmaceuticals China (BioChina), has successfully passed pre-approval inspections conducted by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). This approval allows its customer to supply biopharmaceuticals to the EU and U.S. markets using products manufactured at BI’s Shanghai facility. The inspections confirmed adherence to ICH, GxP regulations, international manufacturing standards, and patient safety protocols at Boehringer Ingelheim’s OASIS manufacturing site.

Boehringer Ingelheim BioXcellence collaborates with customers to deliver innovative therapies reliably. As one of the world’s largest biopharmaceutical manufacturers and a pioneer in the industry, Boehringer Ingelheim BioXcellence has supplied over 40 commercial products through its extensive global network.- Flcube.com

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