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FDA noted that one of the incoming components used in its manufacturing is known to be high-risk for contamination and Sante relied on the supplier's certificate of analysis rather than conducting its own testing to ensure the component met requirements
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Importantly, these implications were observed without direct immunosuppression of specific cytokines such as TNF, implying a more regulatory mode of action
REGULATORY STATUS NOTICE: BPC-157 is not approved by the FDA for human therapeutic use
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