Our Spanish manufacturing site, Derivados Quimicos, was inspected by Servicio de Ordenacion y Atencion Farmaceutica from Murcia Government on behalf of AEMPS (Agencia Española del Medicamento y Productos Sanitarios) from January 21st to February 2nd of present year.
This was a routine inspection requested by the site for the inclusion of a new API (Nicardipine HCl), despite that previous GMP certificate was still in force till October 2024. The inspection, focused on the entire APIs portfolio and the overall Quality System Management, was completed successfully without critical and major observations, with a rapid follow-up and emission of GMP certificate from AEMPS.
“The history of Olon shows a track record of regulatory compliance inspections performed by US FDA, ANVISA, PMDA, AIFA and other authorities, all with positive outcomes. Our state-of-the-art facilities and the expertise in our organization provide the type of quality that is expected by a leader APIs producer” commented Marcello Buson, Head of Global Operations Olon Group.