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The applicant stated that it is seeking De Novo classification from FDA for the same indication

Information: BIOLAB BPC-157 HCL 100 mcg (60 capsules) with laboratory-confirmed content of the active substance - the test showed 317 mcg/caps., which confirms the presence of the substance in the product

10.1093/mutage/13.6.619 Mutagenesis 10 Coln-LorenzoE.SerranoA.NicholasH

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The GHK-Cu / BPC-157 / TB-500 / Epitalon Peptide Blend is a next-generation, physician-formulated therapy engineered for full-spectrum cellular regeneration