Lupin secures USFDA nod for Azilsartan Medoxomil Tablets

Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Azilsartan Medoxomil Tablets, 40 mg and 80 mg.

The product is a generic equivalent of Edarbi Tablets, 40 mg and 80 mg, of Azurity Pharmaceuticals, Inc.

The product will be manufactured at Lupin's facility in Nagpur, India.

Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of USD 101 million in the U.S. (IQVIA MAT March 2022).

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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.\

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.

The company invested 8.7% of its revenue in research and development in FY22.

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