SMS Pharmaceuticals’ Associate VKT Pharma Secures US FDA Nod for Reformulated Ranitidine, Signaling Market Comeback

SMS Pharmaceuticals Limited’s associate company, VKT Pharma, has achieved a significant regulatory milestone by obtaining US Food and Drug Administration (FDA) approval for its reformulated ranitidine tablets. The approval covers two strengths, 150mg and 300mg, and represents the first green light for ranitidine’s market return in the US since its withdrawal five years ago due to concerns about N-nitrosodimethylamine (NDMA) impurities.

The reformulation involved extensive safety testing and manufacturing process enhancements aimed at eliminating the formation of NDMA impurities during product shelf-life. This ensures that the drug is safe and meets stringent US regulatory standards. Ranitidine is widely used to reduce stomach acid and treat conditions such as gastroesophageal reflux disease (GERD) and peptic ulcers. The FDA approval is expected to restore patient access to this essential medication.

Key highlights:

FDA approval granted to VKT Pharma’s reformulated ranitidine tablets in 150mg and 300mg doses

Marks the re-entry of ranitidine into the US pharmaceutical market after a five-year hiatus

Reformulation addresses previous safety concerns related to NDMA impurity formation

Expected to increase patient access to critical acid-reducing therapy

The approval underscores SMS Pharmaceuticals’ commitment to quality and regulatory compliance

Potential growth driver for SMS Pharmaceuticals through associate company’s expanded market footprint

Source: Reuters, FDA official announcements, SMS Pharmaceuticals Limited corporate disclosures