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However, GMP certification covers manufacturing process rather than product efficacy

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FDA cites potential immunogenicity from aggregation and peptide-related impurities and states that human safety data are limited

Sezer U, Erciyas K, stn K, Pehlivan Y, Ziya enyurt S, Aksoy N, Tarakolu M, Tays S, Onat AM

The results of the study show that moderate unconjugated hyperbilirubinemia, which usually occurs in patients with Gilberts syndrome, has a protective effect