SMS Pharmaceuticals Limited (SMS Pharma) has confirmed that its associate company, VKT Pharma, has received approval from the US Food and Drug Administration (US FDA) for its reformulated Ranitidine tablets in 150 mg and 300 mg strengths. This approval marks the medication’s return to the US market after a five-year pause.
The US FDA’s clearance follows detailed safety evaluations and manufacturing enhancements carried out to address earlier concerns linked to NDMA impurity formation. With these improvements in place, the reformulated version meets current regulatory requirements.
Ranitidine, widely used as an acid-reducing treatment, had been unavailable in the US due to impurity-related issues. The newly approved formulation is expected to restore access for patients who depend on the medicine for managing acid-related health conditions.
SMS Pharma noted that the US re-entry of the medication comes after compliance with the agency’s updated safety expectations, allowing VKT Pharma to resume supplying the product to the market.
