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API Sameness

Meaning

API Sameness refers to the criterion where the Active Pharmaceutical Ingredient (API) in a generic or compounded medication is chemically identical to the API in the original, brand-name reference product. This concept is fundamental to ensuring that the core therapeutic substance, often a bio-identical hormone like estradiol or progesterone, possesses the same molecular structure, purity, and concentration as the established drug. Achieving true API sameness is a prerequisite for establishing pharmaceutical equivalence and is critical for predictable clinical outcomes in hormonal therapies. It provides a baseline assurance of quality for all pharmaceutical agents.