Aurobindo Pharma receives approval for Sevelamer carbonate

India’s leading drug maker, Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer carbonate oral suspension, 0.8 gram and 2.4 gram. Sevelamer Carbonate oral suspension is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension.

The drug has been launched immediately as Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, the company said in a filing to the Bombay Stock Exchange.

The product has an estimated market size of US$ 140 million for the 12-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 has a total of 323 ANDA approvals (288 Final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.

On Thursday’s trade at 12:03 pm, the stock was quoting at Rs 636.75 per share. The stock opened at Rs 602 and touched a high of Rs 640.80, with a hike of 5.87 percent.