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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.


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The development and manufacturing of APIs require strict adherence to regulatory standards to ensure safety and efficacy. Organizations such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) impose rigorous guidelines on the production process, emphasizing quality control, stability testing, and proper documentation.


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