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Umicore API Facility Passes cGMP Audit

The plant manufactures four oncology APIs produced for global markets according to the latest international guideline

By: Betsy Louda

, Contract Pharma

Umicore’s Active Pharmaceutical Ingredients facility in Pilar, Buenos Aires, successfully passed its second cGMP audit by the US Food and Drug Administration.

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. The 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. 

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