Lupin gets US health regulator nod for Empagliflozin tablets

Pharma major, Lupin Limited had announced on Tuesday that it has received regulatory approval from United States Food and Drug Administration (USFDA) for its Empagliflozin tablets, 10 mg and 25 mg to market a generic version of Jardiance tablets, 10 mg, and 25 mg, of Boehringer Ingelheim Pharmaceuticals.

Empagliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

According to MAT data for March 2020 from IMS Health and Quintiles, the drug had annual sales of approximately US$ 4,368 million in the US. Hence, the development of approval is likely to be positive for the company’s revenue in the quarters ahead.

Headquartered in Mumbai, Lupin is an innovation-led transnational pharmaceutical company. It develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

Lupin is the third-largest pharmaceutical company in the US by prescriptions and in India, by global revenue. The company invests 9.6 per cent of its revenue on research and development.

At 3 pm on Wednesday, the stock of Lupin was trading at Rs 928.50, lower by 1.29 per cent or Rs 12.15 per share on BSE, against a 0.07 per cent decline in the benchmark index. The 52-week high is recorded at Rs 955.85 and the 52-week low is Rs 505 on BSE.