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Lilly GMPs Will Not Deter Product Rollout, Firm Says

Executive Summary

The remaining Lilly products delayed by good manufacturing practices compliance problems could be approved by FDA before the company has fully implemented its GMP improvement program

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Lilly Revisits Priorities: GMPs Awarded Same Status As R&D, Marketing

Lilly is rearranging its operating priorities to put manufacturing processes on the same level as R&D and sales and marketing, CEO Sidney Taurel told investors

Lilly Revisits Priorities: GMPs Awarded Same Status As R&D, Marketing

Lilly is rearranging its operating priorities to put manufacturing processes on the same level as R&D and sales and marketing, CEO Sidney Taurel told investors

Lilly’s “normal” 483

Lilly receives FDA 483 report "as part of the normal inspection process" for its dry and injectable facilities in Indianapolis. Company says that the outcome of the inspection is not expected to delay the expected fourth quarter launch of the antidepressant Cymbalta, which is manufactured at the dry facility. Inspection ran from May 5-23; the 483 was issued on May 29. Lilly has said that it expects FDA will judge its facilities based on the company's GMP progress rather than its absolute compliance (1"The Pink Sheet" April 28, 2003, p. 31)...

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