Representative Image
SMS Pharmaceuticals Limited (SMS Pharma), trading on the NSE (Symbol: SMSPHARMA) and BSE (Code: 532815), announced a major regulatory achievement on 26th November, 2025, confirming that its associate company, VKT Pharma, has received US Food and Drug Administration (FDA) approval for its reformulated Ranitidine tablets.
This significant approval covers both 150mg and 300mg strengths of the medication.
The decision enables the re-entry of this important acid-reducing medication into the US market after an absence lasting approximately five years.
The return of the drug was contingent upon rigorous regulatory oversight. The US FDA approval was granted only after extensive safety testing and comprehensive manufacturing improvements were implemented.
These measures were specifically designed to address previous concerns regarding the formation of NDMA impurity.
SMS Pharma expects the successful approval to increase patient access to this important medication for those who rely on it for various health conditions. The announcement was made via a press release filed with both the BSE Limited and the National Stock Exchange of India Ltd.
Note: The disclosure includes a disclaimer that certain statements made within the press release may be forward-looking and are subject to risks, including changes in the economic environment, tax laws, inflation, and litigation; actual results could differ substantially from those expressed or implied. The information regarding the press release will also be available on the company’s website at www.smspharma.com.
Disclaimer: The information provided is for educational purposes only and does not constitute financial advice. We are not registered financial advisors. Please conduct your own research and consult a qualified advisor before making investment decisions. Any investment decisions you make based on this information are solely at your own risk.
