Lupin gets USFDA nod for Sevelamer Carbonate tablets; stock gains 2 per cent

Lupin Limited gets approval from United States Food & Drug Administration (USFDA) for its Sevelamer Carbonate tablets, 800 mg. It is a generic equivalent of Renvela tablets, 800 mg of Genzyme Corporation. 

These tablets are indicated for the control of serum phosphorus in adults and children of 6 years & above with chronic kidney disease on dialysis. 

Phosphorus is an essential element in the cellular structure, cytoplasm, and mitochondrium. Disorders of serum phosphorus may occur from three possibilities i.e. dietary intake, GI disorders, and renal handling. The kidney remains the most significant organ regulating phosphate homeostasis, and most of the clinical perturbations seen are caused by renal phosphate wasting. 

As per the data provided by IQVIA MAT for September 2020, Sevelamer Carbonate tablets had estimated annual sales of USD 348 million in the US. 

Lupin Ltd develops and commercialises a wide range of branded and generic formulations, biotechnology products & APIs in over 100 markets in the US, India, South Africa & across the Asia Pacific (APAC), Latin America (LATAM), Europe and the Middle East regions. 

On Monday, the stock of Lupin was trading 2.3 per cent higher at Rs 1,103.65 from its previous close of Rs 1,079.55 on BSE.