Lupin receives USFDA approval for Sevelamer Hydrochloride tablets
Mumbai/UNI: Pharma major Lupin on Thursday said that it has received approval for its Sevelamer Hydrochloride Tablets, 400 mg and 800 mg from the United States Food and Drug Administration (USFDA) to market a generic equivalent of Renagel Tablets, 400 mg, and 800 mg of Genzyme Corporation.
The product will be manufactured at Lupin's facility in Nagpur, India.
Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
Sevelamer Hydrochloride Tablets had an estimated annual sales of USD 80 million in the US (IQVIA MAT March 2021).