Lupin US Launches On Track But Albuterol 'Clarity' Awaited
Defers FDA Reinspection Timelines
After lower growth in India business and impaired operations at five manufacturing units hit by US FDA action impacted Lupin's third-quarter revenues, one-offs sent its net profit crashing. While deferring reinspection timelines for its Goa and Somerset plants, the company remains confident of adding at least 15 products to its US portfolio in FY21.
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The launch of injectable doxercalciferol and FDA approvals for mycophenolic acid delayed-release tablets and betamethasone dipropionate ointment could add some cheer to Lupin whose high-potential launches in the US have seen delays. However, analysts are not very enthused.
As the Indian pharma industry catches up with digitization, Lupin partners with Aptar to launch a smart device for MDIs. While there is a need for the product, whether it will find favor in a price-sensitive market remains to be seen.