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The molecule was first identified and studied by the Sikiric research group in Croatia starting in the early 1990s, and the bulk of the preclinical evidence base comes from more than three decades of rat and rodent studies showing consistent tissue-repair, anti-inflammatory, and gastroprotective effects

That said, several important safety considerations remain: No FDA approval : BPC-157 is not approved by the U.S

Industry Response: The compounding pharmacy industry, medical practitioners, and patient advocacy groups pushed back against the Category 2 classification, arguing that the safety data did not support such a restrictive designation

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