This approval marks the re-entry of this important acid-reducing medication into the US market after a five-year absence. The product had previously been withdrawn over concerns related to the formation of NDMA, a potential carcinogenic impurity.
According to the company, 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 specializing in APIs and intermediates for global customers. The company operates two state-of-the-art manufacturing facilities in Hyderabad and Vizag.
The company’s consolidated net profit jumped 79.5% to Rs 25.31 crore on 23.2% increase in revenue from operations to Rs 242.43 crore in Q2 FY26 over Q2 FY25.