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The company, which makes fermentation and semi-synthetic antibiotic drug substances and drug products, said FDA's guidance also fails to provide clarification for adjusted thresholds for impurities in products such as its own

A Category 1 listing only means a compound can be legally prepared by 503A compounding pharmacies it does not make BPC-157 an FDA-approved drug

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The reduced volume also lowers the operating weight of units by an average of 16%

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