Empowering API Manufacturing: Perspectives From a Contract Development and Manufacturing Organization

As a Contract Development and Manufacturing Organization (CDMO), navigating the landscape of EU API manufacturing presents critical challenges and opportunities. In response to Cefic’s November 2023 recommendations, CDMOs have an important role to play to foster sustainable growth, support reshoring initiatives, and drive innovation investment to prioritize supply security and social-environmental standards. The decline in EU-based API production underscores the urgency to address competitive pressures from global markets and EU regulatory dynamics. This presentation examines the implications for CDMOs, offering insights into strategies to strengthen API manufacturing capabilities, enhance global competitiveness, and contribute to healthcare resilience.