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Boon For Lupin As FDA Upgrades Somerset Site Status

Stricken US Facility Handed Voluntary Action Indicated Status By FDA

Executive Summary

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.

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Even as it prepares for competition from an authorized generic, Lupin expects a launch of its generic to Boehringer’s blockbuster Spiriva in the fourth quarter of FY23. It hopes the launch will help its position in the US, where it has exited low margin products amid heightened competition, leading in turn to manufacturing job losses in India

Lupin Counts On Generic Spiriva Launch In Q4 To Turn US Tide

Even as it prepares for competition from an authorized generic, Lupin expects a launch of its generic to Boehringer’s blockbuster Spiriva in the fourth quarter of FY23. It hopes the launch will help its position in the US, where it has exited low margin products amid heightened competition, leading in turn to manufacturing job losses in India

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