Eleven of Viatris’ products have been halted from entering the US after the firm’s oral finished dose manufacturing facility in Indore, India was subject to a US Food and Drug Administration warning letter and import alert – though a further four shortage-hit products will continue to be distributed, subject to certain conditions.
FDA Blocks Viatris US Products With India Facility Import Alert
Viatris: Necessary Corrective And Preventive Actions Are Well Underway
Viatris has told investors it will incorporate any potential future financial impact into its soon-to-be-released 2025 guidance ranges, after the firm’s oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.

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Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.
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