Umicore succeeded second Food and Drug Administration audit at its Argentinean manufacturing site
Umicore’s Active Pharmaceutical Ingredients facility in Pilar, Buenos Aires, successfully passed its second cGMP (current Good Manufacturing Practice) audit by the US Food and Drug Administration (FDA) in May 2018. The Auditor acknowledged that both the production area and the associated documentation were well maintained, rewarding Umicore’s constant focus on the quality of its production processes and systems.
Umicore manufactures in Pilar cisplatin, carboplatin, oxaliplatin and arsenic trioxide: four oncology APIs produced for global markets according to the latest international guidelines. It additionally exclusively manufactures a few high potency APIs under customer contracts.
Umicore's state of the art facility in Pilar opened in 2009 and offers high quality products, professional services – such as exclusive development and synthesis and regulatory support or IP management and strategy. Umicore is committed to further develop the facility to ensure first class products and services to its global customers.