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Lupin Gets USFDA Nod To Market Sevelamer Hydrochloride Tablets

Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

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Drug maker Lupin on Thursday said it has received approval from the US health regulator to market Sevelamer Hydrochloride tablets, which is used to control serum phosphorus in patients with chronic kidney disease, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) to market its generic version in strengths of 400 mg and 800 mg, Lupin said in a regulatory filing.

The Mumbai-based drug firm's product is the generic version of Genzyme Corporation's Renagel.

The product will be manufactured at the company's Nagpur plant, Lupin noted.

Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

As per IQVIA March data, Sevelamer Hydrochloride tablets had estimated annual sales of USD 80 million in the US.

(PTI)