Lupin receives approval from USFDA for Sevelamer Carbonate for Oral Suspension

27 Dec 2021 Evaluate

Lupin 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 $51.7 million in the U.S. (IQVIA MAT September 2021).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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