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The manufacturing of APIs is a highly regulated process that requires adherence to stringent guidelines set forth by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations ensure that the APIs produced are of high quality, consistent, and safe for human consumption. Manufacturers must conduct extensive testing and validation throughout the production process to guarantee that their APIs meet these rigorous standards.
active pharmaceutical ingredient api definition...
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