Clinical Commercial Peptide APIs. Our teams have developed, scaled up, and manufactured up to 200 kg of GMP peptide APIs using the solid-phase process, as well as up to 50 kg of peptide APIs through convergent solid and solution-phase synthesis processes. We also develop and manufacture custom peptides, New Drug Peptide Entities, Encapsulated peptides, and oral lozenges under current Good Manufacturing Practice (cGMP) conditions.
FDA-registered with Vitamin B12-100mcg API. Manufactured with approved DMF according to the Federal Food, Drug, and Cosmetic Act for commercial distribution, ANDA registration, or clinical trials.