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The impurity highlights the risks to patients of haphazardly mixing untested additives with complex molecules like tirzepatide without rigorous testing, clinical trials and FDA approval, Lilly said

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While these drugs have not undergone large-scale clinical trials like their branded counterparts, you can still prescribe them responsibly by adhering to established best practices for safety and compliance

Importantly, the study showed consistent results across scales, maintaining product quality while increasing batch sizes