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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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Once an API is developed, it must undergo rigorous testing and validation to ensure its safety and effectiveness. This includes preclinical studies and multiple phases of clinical trials. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) closely monitor these processes to safeguard public health. Only when a drug passes through these stringent evaluations can it reach the market.
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