Active Pharmaceutical Ingredient (API)
– A standardized biologically active substance (or mixture thereof) with specific therapeutic efficacy, produced through synthesis, biotechnology, or derived from human, animal, plant, or mineral sources, and approved for medical use in the manufacture of pharmaceutical preparations. All APIs are categorized as innovative/original or generic/reproduced. Based on toxicity levels, APIs are classified as toxic (with very high biological activity), potent (with high biological activity, included in the list of potent medicinal substances), and ordinary.
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