Umicore Facility in Argentinia Passes new European cGMP Audit
Umicore’s active pharmaceutical ingredients (API) facility in Pilar, Buenos Aires, successfully underwent a European cGMP inspection by the German Health and Medicine Authority. The audit confirms Umicore ability to manufacture highly potent anticancer APIs under current Good Manufacturing Practice 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 has been producing and marketing high potency APIs (hAPIs) for more than 20 years – complying with cGMP requirements, ICH guidelines and all applicable regulations in the pharmaceutical industry. The 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.
The facility has been inspected and endorsed by a variety of health agencies and customers. In 2014, an independent, third-party audit in accordance with DIN/ISO14001 norms verified the facility's high standards and in 2016 it underwent a successful inspection by the USFDA. 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. Managed under European standards and values, the Argentinian site offers our customers an advantageous cost competitiveness as well as unique and innovative options to develop launch strategies for generic molecules.
