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These facilities cannot make copies of an FDA-approved medication unless the drug is on the FDA shortage list and are only allowed to mass produce the active ingredient as per Section 503B of the FD&C Act

270 Moreover, advancements in molecular biology have identified key growth factors and cytokines involved in tissue repair, such as transforming growth factor-beta (TGF-) and insulin-like growth factor-1 (IGF-1)

The company's materials include discussion of how BPC-157 is described across preclinical research and consumer-facing wellness categories, including commonly used terminology such as "most effective" within competitive positioning language