Aurobindo Pharma Limited, one of the top Indian pharmaceutical companies, has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, which is used to lower high blood phosphorus levels in patients who are on dialysis due to chronic kidney disease.
The Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients will manufacture Sevelamer Carbonate oral suspension in 0.8 gm and 2.4 gm strengths. The product will be launched immediately.
Having an estimated market size of $140 million in the US, Sevelamer is given to patients with chronic kidney disease (CKD) on dialysis to prevent unsafe buildup of minerals in the body, and possibly decrease the risk of heart disease and strokes.
Sevelamer Carbonate oral suspension is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension.
With the approval of Sevelamer by USFDA, Aurobindo Pharma’s formulation facility in Hyderabad, that is used for manufacturing oral products, has now 116 Abbreviated New Drug Applications (ANDAs) under its belt.
Aurobindo’s manufacturing facilities are approved by several leading regulatory agencies like USFDA, UK MHRA, Japan PMDA, World Health Organisation, Health Canada, MCC South Africa and ANVISA Brazil.