SMS Pharmaceuticals’ stock climbed over 4% in early trade after the company announced that its associate firm, VKT Pharma, has received approval from the US Food and Drug Administration (US FDA) for its newly reformulated Ranitidine tablets in 150 mg and 300 mg strengths. The green signal from the regulator marks the drug’s return to the American market after a gap of five years.
The US FDA approval comes following extensive safety evaluations, along with key manufacturing improvements made by VKT Pharma to resolve earlier concerns related to NDMA impurity formation. These impurities had triggered a widespread withdrawal of Ranitidine products from the US market, prompting pharmaceutical companies to overhaul their formulations.
With the updated version now meeting the FDA’s current safety and quality standards, the medication is set to re-enter the US market, bringing relief to patients who have long relied on Ranitidine for managing acid-related issues. The drug has historically been used to treat conditions such as heartburn, acid reflux, and ulcers.
As of 9:29 AM, the shares were trading 4.22% higher at Rs 285.10.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
