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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.


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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