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Alcami St. Louis Facility Issued European Medicines Agency Certification

AlcamiStLouis-0001-of-0001-73281-1Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a Certificate of Compliance by the European Medicines Agency (EMA) Tuesday, April 23, 2019, following the facility’s recent successful Good Manufacturing Practice (GMP) inspection. 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). The outcome reflects the company’s unwavering commitments to quality, reliability, responsible operations, and strict adherence to regulatory compliance.

Alcami unveiled its state-of-the-art Center of Excellence in St. Louis’s Cortex Innovation Community, a 200-acre innovation hub and technology district, in September 2017. The facility provides analytical testing services for manufacturers’ new drug entities, generics, animal health products, active pharmaceutical ingredients, raw materials, in-process goods, medicated consumer health products, chemicals, and biologics. Using a wide variety of techniques to identify the chemical makeup of a sample, the laboratory helps ensure the drugs Alcami’s customers have developed are safe and effective for patients around the world.

Since its grand opening, the Center of Excellence has received many accolades. 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, celebrating its industry-leading accomplishments, and applauding the organization for improving St. Louis citizens’ quality of life.

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Topics: Company News Regulatory Compliance Analytical Testing Analytical Development