Who makes peptide APIs, what GMP means, and the major US-based players.
Most peptide APIs are manufactured via solid-phase peptide synthesis (SPPS): amino acids coupled sequentially to a resin, cleaved, purified by HPLC, and lyophilized. GMP adds validated processes, environmental monitoring, equipment calibration, full batch documentation, and regulatory inspections to this chemistry. GMP explained →
One of the largest US peptide manufacturers. FDA-inspected, cGMP. 500+ staff. Clinical through commercial scale.
Global leader. Decades of experience across research through commercial GMP. Serves major pharma companies.
CDMO with 25+ years. 300+ CMC projects. Discovery through commercial GMP production.
Current GMP certificate with issuing authority. FDA inspection history. Drug Master File status. Batch-specific COAs. Stability data. US customer references. Full evaluation guide →