Aurobindo Pharma has received final approval from the USFDA to manufacture Sevelamer Carbonate tablets 800 mg and market the tablets in the United States. The tablets are indicated for control of serum phosphorus in patients with chronic kidney disease on dialysis.
This product, a therapeutic equivalent generic version of Genzyme's Renvela tablets, is being launched immediately. The approved product has an estimated market size of 12,730 crore for the 12 months to May 2017. Aurobindo Pharma has a total of 331 ANDA approvals from the United States.