Aurobindo now has a total of 323 ANDA approvals
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm. Sevelamer Carbonate oral suspension is a therapeutic equivalent generic version of Genzyme’s Renvela® oral suspension. The product is being launched immediately.
Sevelamer Carbonate oral suspension 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 US$ 140 million for the twelve months ending April 2017 according to IMS.
This is the 116th ANDA (including 19 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 323 ANDA approvals (288 Final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.