Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health.
The approval is for Sevelamer Carbonate Tablets, 800 mg, which is an AB-rated generic equivalent to Renvela.
The drug is used to control the amount of phosphorus in the blood of adults with chronic kidney disease (CKD) on dialysis.
“Commercial launch will commence immediately,” Cipla said.
The company has operations in more than 80 countries and has a portfolio of 1500 products.