Lupin receives approval from USFDA for Sevelamer Carbonate for Oral Suspension

Global pharma major Lupin Limited (Lupin) on Saturday, December 25, 2021, announced that it 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 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 USD 51.7 million in the U.S. (IQVIA MAT September 2021).

Besides, Lupin yesterday, on Friday, said that it has received tentative approval from the USFDA for its ANDA Azilsartan Medoxomil Tablets, 40 mg, and 80 mg to market a generic equivalent of Edarbi Tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LW. This product will be manufactured at Lupin's Nagpur facility in India.

Azilsartan Medoxomil Tablets (RLD: Edarbi® Tablets) had estimated annual sales of USD 103.4 million in the U.S. (IQVIA MAT September 2021).

About Lupin

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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Shares of Lupin Limited closed at Rs 897.15 per share, down 1.66 per cent on BSE as compared to the previous close of Rs. 912.25 per share.