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Efficacy and Safety


One significant aspect of APIs is their regulation. Governments and international organizations, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines to ensure the safety, efficacy, and quality of pharmaceutical products. The API list not only aids in the compliance with these regulations but also helps in tracking the manufacturing and distribution of medications. Each API must undergo rigorous testing and validation before it can be deemed safe for public use.


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