Lupin In Tailspin After Two-In-One FDA Warning Letter
After a weak second quarter, Lupin had a nasty surprise with the FDA issuing a combined warning letter for two of its Indian manufacturing sites. The FDA action is expected to setback US product approvals, though Lupin maintained that its “structural story of growth” remained intact.
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Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.
Lupin delivered a shaky Q3 as profit margins fell following complications with metformin and oseltamivir, but the firm appears confident that several impending high-value launches will set it back on the right track.
Lupin says it is rebuilding its reputation for quality and compliance after the US FDA awarded VAI status to a manufacturing facility in Goa that was hit by a warning letter back in 2017.