The landscape for peptide manufacturers, particularly those supplying products labeled “For Research Use Only” (RUO), is undergoing a significant transformation. Regulatory bodies are intensifying their scrutiny, shifting their enforcement focus beyond just the sellers of RUO peptides and directly toward the manufacturers and their intricate supply chains.
This pivotal change elevates the compliance burden for the entire industry, from the initial production of Active Pharmaceutical Ingredients (APIs) to the final testing of peptide products.
To fully understand the strategic implications, a closer analysis of the regulatory framework is required.
