Materials group has been making further improvements to the plant in Pilar, Buenos Aires
The Pilar plant in Argentina has passed its first European audit
Global materials technology and recycling group Umicore reports that its API (Active Pharmaceutical Ingredients) facility in Pilar, Buenos Aires, Argentina successfully passed its first European cGMP (current Good Manufacturing Practice) audit by the Danish Health and Medicine Authority.
The GMP-certificate enables Belgium-headquartered Umicore to sell highly potent anticancer APIs in Europe. The firm says the European pharmaceutical industry is currently experiencing reduced API availability in this field.
Michael Schwarz, Director Global API Business, at Umicore, said: 'This is an important milestone for Umicore’s growing activities in platinum-based highly potent anticancer APIs and follows a number of successful inspections by international customers and Latin American health authorities. This new success paves the way for further growth by contributing to the expansion of our current market leadership in Latin America towards Europe and other regions.'
Umicore has been making further improvements at its Argentinian plant not only in terms of production processes and systems but also with regard to the quality control of the APIs cisplatin, carboplatin and oxaliplatin that are manufactured there for sale in global markets.
The Pilar plant opened in 2009 and offers high quality products, professional services – such as quality assurance and quality control – and competitive business terms.