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The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.
On April 29, 2019, Alcami announced that its St. Louis, MO, center of excellence for advanced analytical testing was issued a certificate of compliance by the European Medicines Agency (EMA) on April 23, 2019 following the facility’s recent successful GMP inspection.
The certification confirms the site is compliant with GMP laboratory storage and testing practices and enables the laboratory to process more commercial products for the European Union (EU). In September 2017, Alcami opened its center of excellence in St. Louis’s Cortex Innovation Community, a 200-acre innovation hub and technology district. The facility provides analytical testing services for manufacturers’ new drug entities, generics, animal health products, APIs, raw materials, in-process goods, medicated consumer health products, chemicals, and biologics. In May 2018, the site was honored by the Missouri House of Representatives and St. Louis Mayor Lyda Krewson with a resolution and letter of commendation recognizing the company’s operational excellence and accomplishments.