Aurobindo Pharma said it received final approval from the US Food & Drug Administration to manufacture generic version of kidney drug Renvela from Genzyme.
Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm is being launched immediately, the company said.
The drug had a market size of US$140 million (Rs 900 cr) for the twelve months ending April 2017.
The formulation is used for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
“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 Pharma said.
Aurobindo now has a total of 323 ANDA approvals from USFDA, comprising 288 final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals.
The company is headquartered at Hyderabad, India, and manufactures generic pharmaceuticals and active pharmaceutical ingredients.
It focuses on antibiotic, anti-retroviral, cardiovascular, central nervous system, gastroenterological, anti-allergic and anti-diabetic drugs. It sells its products globally, in over 150 countries.