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CMC for Peptides

Meaning

CMC for Peptides stands for Chemistry, Manufacturing, and Controls for peptide drug products, representing the comprehensive regulatory dossier required by health authorities like the FDA and EMA to demonstrate the quality, safety, and purity of a synthetic peptide therapeutic. This information is the technical foundation of a drug application, ensuring that the active pharmaceutical ingredient, or API, is consistently produced to a high standard. It covers everything from the starting materials and synthesis process to the final product’s impurity profile and stability data. A robust CMC package is non-negotiable for clinical trial authorization and market approval.