An active pharmaceutical ingredient (API) is a substance, or a mixture of ingredients, combined in the manufacture of a pharmaceutical or drug. Active pharmaceutical ingredients directly impact disease. Their pharmacological activity plays a direct role in the diagnosis, cure, mitigation, treatment, or prevention of disease. Active pharmaceutical ingredients affect the structure and function of the human body. Inactive ingredients in a pharmaceutical may be referred to as "bulk pharmaceutical chemicals (BPCs)." The term active pharmaceutical ingredient may refer to an active chemical within an FDA-regulated drug, or API might mean the entire drug with its active and inactive ingredients.
Highly Regulated Active Pharmaceutical Ingredients