SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements

SMS Pharmaceuticals Limited (SMS Pharma) has announced that the US Food and Drug Administration (US FDA) has approved its associate company VKT Pharma's reformulated Ranitidine tablets in 150mg and 300mg strengths. This approval marks the re-entry of this important acid-reducing medication into the US market after a five-year absence.

The approval by the US FDA comes after extensive safety testing and manufacturing improvements that address previous concerns regarding the formation of NDMA impurity. It is expected to increase patient access to this important medication for patients who rely on it for various health conditions.