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Wegovy Manufacturing Delays Highlight Challenges Of Managing Aging Facility Risks

Executive Summary

While pharmaceutical manufacturing facilities can age well, the care and attention aging facilities require can arise at inopportune moments, as was the case for Novo’s Wegovy launch. Even so, Catalent aims to make quick work of air handler replacement to get the new weight-loss drug back into production, despite typically long lead times, consultant says.

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US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

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Unrelated US FDA inspection led contract manufacturer to stop filling Wegovy syringes before alternate manufacturing facilities became available.

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