Lupin gets USFDA nod for Sevelamer Hydrochloride tablets for treating chronic kidney disease

Lupin Limited has received approval for its Sevelamer Hydrochloride tablets, 400 mg & 800 mg from United States Food & Drug Administration (USFDA) to market a generic equivalent of Renagel tablets, 400 mg & 800 mg, of Genzyme Corporation. The product will be manufactured at Lupin’s facility in Nagpur (Maharashtra). 

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

As per IQVIA MAT’s data for March 2021, Sevelamer Hydrochloride tablets had estimated annual sales of USD 80 million in the US. 

Also, this week, the company’s UK subsidiary had received approval from Medicines & Healthcare products Regulatory Agency (MHRA) to market Luforbec 100/6 µg pressurised metered-dose inhaler (pMDI), the first-branded generic of Fostair 100/6 µg pMDI. It is indicated for regular treatment of asthma as well as for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD). 

Lupin is an innovation-led transnational pharmaceutical company, which develops & commercialises a wide range of branded and generic formulations, biotechnology products along with APIs in over 100 markets in the US, India, South Africa, and across Asia Pacific (APAC), Latin America (LATAM), Europe & Middle-East regions. 

On Thursday, the stock of Lupin closed 1.21 per cent lower at Rs 1,162.65 from its previous close of Rs 1,176.85 on BSE.