Umicore’s API (Active Pharmaceutical Ingredients) facility in Pilar, Buenos Aires, successfully underwent a European cGMP (current Good Manufacturing Practice) inspection by the German Health and Medicine Authority.
The success of this new audit confirms Umicore ability to manufacture highly potent anticancer APIs at highest quality standards and to sell them in Europe.
Michael Schwarz, Director Global API Business, comments: “This is an important success for Umicore’s activities in highly potent anticancer APIs. It follows a number of successful inspections by international customers and health authorities and it shows that our manufacturing site has fully integrated the principles and guidelines of good manufacturing practices. This will strongly support our further growth in the European market.”
Umicore´s state of the art facility in Pilar opened in 2009 and manufactures cisplatin, carboplatin, oxaliplatin and arsenic(III) oxide for global markets, based on current international guidelines. It also exclusively produces a number of high quality proprietary APIs. Umicore’s API business offers professional services – such as exclusive hAPI development and manufacturing, IP and regulatory support, quality assurance and quality control – and highly competitive business terms. Umicore is committed to further develop the facility to be able to provide the first class products and services its global customers will need in future.