Lupin receives U.S. FDA approval for Sevelamer Carbonate

Lupin receives U.S. FDA approval for Sevelamer Carbonate

By: IPP Bureau

Last updated : December 27, 2021 10:22 am



This product will be manufactured at Lupin's Goa facility in India


Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets to market a generic equivalent of Renvela for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme. This product will be manufactured at Lupin's Goa facility in India.

Sevelamer Carbonate for Oral Suspension (RLD: Renvela for Oral Suspension) had estimated annual sales of US $ 51.7 million in the U.S. (IQVIA MAT September 2021).

Lupin

First Published : December 27, 2021 12:00 am