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. Not affiliated, endorsed, or intended to replace Eli Lilly, Novo Nordisk, or other companies' or FDA-approved brands such as Victoza, Saxenda, Byetta, Ozempic, Rybelsus, Wegovy, Adlyxin, Trulicity, or Mounjaro.