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Research suggests that berberine may support weight loss by improving insulin sensitivity, enhancing glucose metabolism, and influencing fat storage pathways. She also pointed to a meta-analysis that found significant reductions in body weight, BMI and waist circumference with people taking berberine benefits that may also contribute to metabolic health

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Specifically regarding product-related impurities or variants, the guidance states that manufacturers should justify for each new specified peptide-related impurity the ANDA applicant should provide justification for why such impurity does not affect the safety of the proposed generic synthetic peptide (including with respect to immunogenicity) and why it does not affect its effectiveness

PMC+1 Further, their original authorisation and indication were for glucose-controlnot for long-term, standalone obesity treatment