Therapeutically Active Pharmaceutical Ingredient

Therapeutically Active Pharmaceutical Ingredient. Shall mean any substance used in a finished pharmaceutical product, intended to furnish pharmaceutical activity or otherwise have direct effect in the cure, mitigation, treatment or prevention of disease or to have effect in restoring, correcting or modifying physiologic function in human beings. For avoidance of doubt, excipients and inert ingredients without disease-specific therapeutic or pharmacologic effects shall not be considered Therapeutically Active Pharmaceutical Ingredients.