Lupin bags USFDA nod for Sevelamer Carbonate for Oral Suspension
Mumbai: Global pharma major Lupin Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sevelamer Carbonate for Oral Suspension, 0.8 g and 2.4 g packets.
The drug is a generic equivalent of Renvela for Oral Suspension, 0.8 g and 2.4 g Packets of Genzyme.
Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis.
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 USD 51.7 million in the U.S. (IQVIA MAT September 2021).
Read also: Lupin bags USFDA nod for generic equivalent of Edarbi Tablets
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
