Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval

Lupin receives U.S. FDA approval for Sevelamer Carbonate

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

  • By IPP Bureau | December 27, 2021

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).

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