Indian Firms Take Different Paths On Ranitidine
Solara To Reassign Capacity, Strides Considers Relaunch
A double blow to ranitidine medicines – suspension in the EU and a withdrawal request in the US – has caused Indian API and formulation manufacturers to recalibrate their strategies. Amid uncertainty over future prospects for the gastrointestinal drug, Strides is considering a relaunch in the US while Solara is reassigning part of its capacity to manufacture other APIs.
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Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.
Optimistic about the potential of repurposing its antivirals portfolio, Strides plans to soon begin bioequivalence studies for favipiravir, a molecule that has found favor as a COVID-19 therapy in a few countries. It also aims to introduce new products to fill the gap left by the withdrawal of ranitidine from the US market.
In addition to deciding to suspend ranitidine-containing medicines, the European Medicines Agency has issued recommendations on testing patients for DPD deficiency before they are treated with fluorouracil or related medicines.