Mumbai based Glenmark Pharmaceuticals company has received nod from the US health regulator for Selelamer Hydrochloride Tablets, used for controlling the Serum Phosphorous level in patients, suffering from chronic disease related to Kidney.
The approved tablet is the generic version of Renagel Tablets, produced by Genzyme corporation.
Glenmark Pharmaceuticals in a BSE filing stated, “Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (USFDA) for Sevelamer Hydrochloride tablets in the strengths of 400 mg and 800 mg”.
The company currently has a portfolio which consist of 149 products, which it is authorized for the distribution by USFDA.
The annual sales for Renagel Tablets was around $102.1 million as per IQVIA sales data cited by Glenmark pharma.