FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.
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Looking to provide evidence of its extended measures to improve quality, compliance and oversight, Lupin has received positive news from the FDA for its US-based manufacturing facility in Somerset, New Jersey.
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.