Strides Pharma Gets USFDA Approval For Generic Sevelamer Carbonate Oral Suspension

Strides Pharma Science Ltd said that its Singapore subsidiary, Strides Pharma Global Pte Ltd, has gained approval from the US Food and Drug Administration for its generic Sevelamer Carbonate for oral suspension, which is indicated for patients with chronic renal disease on dialysis to prevent hazardous phosphate rises. The US Food and Drug Administration (USFDA) has approved Sevelamer Carbonate for oral suspension in strengths of 0.8g and 2.4g, according to Strides Pharma Science in a regulatory filing. As per the business, the medication is bioequivalent and therapeutically equivalent to the reference listed drug Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme.

"The approval completes the company's Sevelamer Carbonate portfolio...The product is a complex generic with limited players having both the tablets and oral suspension," it said adding, the approved medicine will be manufactured at the company's facility in Bengaluru. According to Strides pharma, the Sevelamer Carbonate market for tablets and oral suspension offers a combined opportunity of USD 212 million, based on IQVIA data. Strides Pharma Science Limited is an Indian pharmaceutical firm based in Bangalore, India. The company makes pharmaceuticals, over-the-counter medications, and nutraceuticals. Softgel capsules, hard-gel capsules, tablets, and dry and wet injectables are among the products available.