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The rigorous regulatory environment in which pharmaceutical companies operate has also influenced API manufacturing processes. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce stringent guidelines to ensure the quality and safety of pharmaceuticals. Consequently, API manufacturers must invest heavily in quality control and compliance measures, making it imperative to adopt advanced technologies such as Process Analytical Technology (PAT). This enables real-time monitoring and control of production processes, ensuring that the end product consistently meets the required specifications.
api manufacture
