SMS Pharmaceuticals’ associate company -- VKT Pharma has received approval from US Food and Drug Administration (USFDA) for 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.
SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specialising in API and intermediates for global customers.
