Pharma Sector Check - Will U.S. FDA Follow Canada, U.K. In Recalling Losartan? Motilal Oswal
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Motilal Oswal Report
From May-September 2021, Canada has recalled over 170 lots of Losartan manufactured by five different companies due to the higher-than-permissible levels of azido impurities, which raises the risk of cancer in patients taking the drug regularly.
With the UK also issuing similar recalls on Losartan in August 2021, along with Irbesartan, there is an increasing risk, that the U.S. Food and Drug Administration may follow suit in recalling Losartan finished formulations, where the limit of azido impurities are found to be higher than permissible levels.
While Indian pharma companies - Aurobindo Pharma Ltd., Cadila Healthcare Ltd. and Lupin Ltd. dominate the Losartan formulations market in the U.S., their exposure is just 1-3% of U.S. sales and ~1% of total sales.
The recall may have a minimal financial impact.
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