Boehringer Ingelheim Biopharmaceuticals China receives nod for supply of EU, US markets
Boehringer Ingelheim Biopharmaceuticals China (BioChina), in collaboration with a customer, has successfully passed pre-approval inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
As a result, the customer is now approved for the supply of the biopharmaceutical to the EU and US markets from product manufactured by Boehringer Ingelheim Biopharmaceuticals China. The inspections validated compliance with ICH, GxP regulations, international manufacturing standards, and patient safety requirements at Boehringer Ingelheim’s OASIS manufacturing site in Shanghai.
“For us as a world-leading contract manufacturer of biopharmaceuticals, the official approvals for our site are a confirmation of our own aspiration to transform lives for generations,” explains Ulrike Falk, Head of Global Quality Biopharma Operations at Boehringer Ingelheim.
Boehringer Ingelheim’s contract manufacturing activities in China, began in 2013.
Through its collaboration and the provision of manufacturing services for this biopharmaceutical, Boehringer Ingelheim Biopharmaceuticals China was the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL). As a result, this customer product is the first innovative biologic commissioned under the new MAH model in China.
“With recent approvals of this biologic by renowned health authorities including EMA, MFDS, and now the FDA, BioChina continues on a transformative journey supplying our long-time partner in expanding global reach. By offering our partner top-tier quality products, BioChina is fully devoted to improving the lives of patients worldwide,” states Dr. Yuguo Zang, Head of BioChina at Boehringer Ingelheim.
Boehringer Ingelheim BioXcellence so far has supplied more than 40 commercial products through its global network.
