SMS Pharma associate VKT Pharma gains US FDA approval for ranitidine

SMS Pharmaceuticals Limited announced on November 26, 2025, that its associate company, VKT Pharma, has received US FDA approval for its reformulated ranitidine tablets in 150mg and 300mg strengths. This approval marks the re-entry of the acid-reducing medication into the US market after a five-year absence.

The FDA's approval follows extensive safety testing and manufacturing improvements addressing previous concerns regarding NDMA impurity formation. This development is expected to enhance patient access to a vital medication for various health conditions.

SMS Pharmaceuticals Limited made this information available on its website. The company's secretary, Thirumalesh Tumma, issued the press release.