Lupin gets USFDA nod for generic equivalent of Renagel Tablets
Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorous in patients with chronic kidney disease (CKD) on dialysis.
Mumbai: Global pharma major, Lupin Limited, has recently announced that the company has received approval for its Sevelamer Hydrochloride Tablets, 400 mg and 800 mg from the United States Food and Drug Administration (USFDA).
The product is 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 (RLD: Renagel) had estimated annual sales of USD 80 million in the U.S. (IQVIA MAT March 2021).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.