Lupin gains on USFDA nod to market Sevelamer Carbonate

NEW DELHI: Shares of Lupin climbed 1.6 per cent in early trade on Monday after the drug firm said it received approval from the US health regulator to market Sevelamer Carbonate for oral suspension. It is used to serum phosphorus with chronic kidney disease (CKD) on dialysis.

The pharmaceutical major’s scrip rose to a high of Rs 912 against the previous close of Rs 897.75 on the NSE.

The company has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) Sevelamer Carbonate for oral suspension in the American market, Lupin said in a statement. The product will be manufactured at the company's Goa facility.


According to data for September 2021 released by IQVIA MAT September, Sevelamer Carbonate for oral suspension had estimated annual sales of $51.7 million in the US, news agency PTI reported.

The latest USFDA approval comes close on the heels of a similar nod from the US health department for blood pressure medication.

The company said on Friday said it received tentative approval from the US health regulator for its generic Azilsartan Medoxomil tablets used to treat high blood pressure.

The tentative approval by the USFDA for the abbreviated new drug application (ANDA) Azilsartan Medoxomil tablets is for 40 mg and 80 mg, Lupin said in a regulatory filing.

These are generic equivalent of Edarbi tablets, 40 mg and 80 mg of Arbor Pharmaceuticals, LW, reports quoted Lupin as saying, adding that the product would be manufactured at Nagpur facility.