An API is any substance or combination of substances used in a finished pharmaceutical product that is intended to provide pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease. APIs can be derived from natural sources or synthesized through chemical processes. The complexity of their structure can vary greatly, from simple molecules to large biological molecules such as proteins and peptides.
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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