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After successful clinical trials, the next step involves scaling up the production of the API to meet regulatory standards. This phase is highly regulated by authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), which require extensive documentation regarding the manufacturing process, purity, and stability of the API. Compliance with Good Manufacturing Practices (GMP) is crucial, as it ensures the quality and safety of the pharmaceutical product.
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