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Once an API has demonstrated its potential through clinical trials, pharmaceutical companies must then ensure that it can be manufactured at scale without compromising its quality. This step often involves the establishment of Good Manufacturing Practices (GMP), which dictate the standards for the production of APIs to guarantee that they meet the necessary quality parameters.
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Formulation refers to the process of combining APIs with other substances to develop a viable drug product. These additional substances, often referred to as excipients, can include fillers, binders, preservatives, and stabilizers. The formulation is crucial because it determines the drug's stability, absorption, distribution, metabolism, and excretion (ADME) properties.
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