Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800mg. Sevelamer Carbonate tablets, a therapeutic equivalent generic version of Genzyme's Renvela tablets. The product is being launched immediately.
Sevelamer Carbonate tablets is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The approved product has an estimated market size of $1.9 billion for the twelve months ending May 2017 according to IMS.
This is the 124th ANDA (including 21 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 331 ANDA approvals (294 Final approvals including 16 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.