SMS Pharmaceuticals' associate company receives USFDA approval for Ranitidine tablets

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Last Updated : Nov 26 2025 | 9:31 AM IST

SMS Pharmaceuticals announced that the US Food and Drug Administration has approved its associate company VKT Pharma's reformulated Ranitidine tablets in 150mg and 300mg strengths. This approval marks the re-entry of this important acid-reducing medication into the US market after a five-year absence.

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.

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First Published: Nov 26 2025 | 9:12 AM IST

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