SMS Pharma gains 18% on U.S FDA nod for reformulated Ranitidine of associate firm

SMS Pharmaceuticals shares gained nearly 18% on the back of U.S. Food and Drug Administration approving associate company VKT Pharma’s reformulated Ranitidine.

The approval also marks the re-entry of the important acid-reducing medication into the U.S. market after a five-year absence. The U.S. FDA has approved VKT Pharma’s reformulated Ranitidine tablets in two strengths, 150 mg and 300 mg.

SMS Pharma shares closed 17.74% higher at ₹322.60 apiece on the BSE on Wednesday.

The U.S. FDA, announcing the decision, said the approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life. The move is expected to increase access to the medication for patients who rely on it for various health conditions.