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Ordering from an FDA-registered 503B outsourcing facility, rather than a standard 503A pharmacy, provides a higher level of quality assurance because 503B facilities must comply with current Good Manufacturing Practice (cGMP) standards

This pace was enabled by several factors: the strength and consistency of the Phase 2 efficacy signals, Eli Lilly's extensive infrastructure for metabolic disease trials built through the tirzepatide program, the availability of well-characterized biomarkers and endpoints for obesity and diabetes, and the increasing regulatory receptivity to obesity treatments as the field matured

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