SMS Pharmaceuticals’ Associate Gains US FDA Approval for Ranitidine
Filing Summary
SMS Pharmaceuticals Limited announced that its associate company, VKT Pharma, has received approval from the US Food and Drug Administration for its reformulated Ranitidine tablets in 150mg and 300mg strengths. This approval allows the re-entry of Ranitidine into the US market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements to address concerns about NDMA impurity. The information is available on the company’s website.
SMS Pharmaceuticals Limited announced that its associate company, VKT Pharma, has received approval from the US Food and Drug Administration for its reformulated Ranitidine tablets in 150mg and 300mg strengths. The approval marks the re-entry of this medication into the US market after a five-year absence.
The approval follows extensive safety testing and manufacturing improvements to address previous concerns regarding the formation of NDMA impurity. This development is intended to increase patient access to the medication for various health conditions.
For further information, interested parties can contact the company or its investor relations representatives. The press release and additional details are available on the company’s website.
SMS Pharmaceuticals Limited focuses on the development and manufacturing of pharmaceutical products. The company prioritizes safety and compliance with regulatory standards in its operations.