pharmaceutical intermediates

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Moreover, APIs are crucial in the development stages of drug formulation. Before a new drug can be approved, researchers must evaluate the API's effectiveness, potential side effects, and appropriate dosage. Each phase of drug development, from preclinical trials to large-scale clinical trials, relies heavily on the stability and performance of the chosen API.


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Once a viable API is developed, extensive clinical trials are conducted to evaluate its safety and efficacy in humans. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive data on the API before granting approval for the drug's market release. These regulatory frameworks ensure that only safe and effective medicines reach patients.


The Future of APIs in Pharmaceuticals


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