Category: Approval/Launch Region: Asia · India Company: Lupin Ltd

Lupin Receives US FDA Approval To Market Generic Renagel Tablets

Lupin Receives US FDA Approval To Market Generic Renagel Tablets
Global pharma major Lupin Limited announced that it has received approval for its sevelamer hydrochloride tablets, 400 mg and 800 mg from the United States Food and Drug Administration (FDA) 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 estimated annual sales of US$ 80 million in the US (IQVIA MAT March 2021).

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