The plant recently underwent a substantial capacity expansion to make sure operations met with internationally recognised good manufacturing practice (GMP) standards.
Thomas Stuart, president of Catalent’s oral technologies unit, said FDA approval “brings our customers an important new supply chain option which further expands Catalent’s global sourcing flexibility.”
Catlent has operated in Argentina since 1953, serving both local and regional pharmaceutical markets. The Buenos Aires facility is the twentieth the firm has registered with the FDA.