Mylan gets warning for Morgantown site
Mylan has suffered a further manufacturing setback at its flagship facility in Morgantown, US, after the US Food and Drug Administration (FDA) issued the site with a warning letter concerning its finished-dosage forms. Following an inspection at the plant from 19 March to 12 April, the agency identified “significant violations” of current good manufacturing practice (cGMP) and said it may withhold new approvals linked with the site.
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The end of July will bring the closure of Viatris’ Morgantown plant, following years of compliance issues for the once flagship Mylan facility. But the company has revealed that it is still in the process of exploring alternatives for the site outside of Viatris.
Mylan has delayed a major restructuring program ahead of its planned merger with Pfizer’s Upjohn unit due to the impact of the COVID-19 pandemic, which at the same time brought tailwinds for the firm’s first-quarter results.
Mylan says its ‘durable’ business model has helped it to withstand pressures from adverse industry trends in 2019, boosted by $1bn in sales from newly-launched products. However, negative currency effects cut the firm’s sales growth from 3% at constant currencies to 1% as reported.