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This study established MC4R-mediated sexual function as a key pharmacological activity of non-selective melanocortin agonists [2]
In the United States, synthetic semaglutide API is generally regulated as a drug substance under the FDA's complex drug substance guidance for peptides, supporting 505(b)(2) New Drug Applications or Abbreviated New Drug Applications (ANDAs) for finished dosage forms, with stringent requirements for physicochemical characterization, impurity profiling (including diastereomers and truncated sequences), and bioequivalence demonstration
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