USFDA26 Nov 2025, 08:24 am
SMS Pharmaceuticals' Associate Company, VKT Pharma, Gets US FDA Approval for Reformulated Ranitidine
AI Summary
SMS Pharmaceuticals Limited (SMS Pharma) is pleased to announce that its associate company VKT Pharma's reformulated Ranitidine tablets in 150mg and 300mg strengths have received US FDA approval. This marks the re-entry of this important acid-reducing medication into the US market after a five-year absence, following extensive safety testing and manufacturing improvements to address previous concerns regarding the formation of NDMA impurity. This approval is expected to increase patient access to this important medication for various health conditions.
Key Highlights
- SMS Pharmaceuticals' associate company, VKT Pharma, receives US FDA approval for its reformulated Ranitidine
- Reformulated Ranitidine is an important acid-reducing medication
- This approval marks the re-entry of the medication into the US market after a five-year absence
- Extensive safety testing and manufacturing improvements have been carried out
- The approval is expected to increase patient access to this important medication