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Lupin gets USFDA nod for hepatitis B virus drug

31-Mar-23 13:22Hrs IST

The approved ANDA is a generic equivalent of Vemlidy Tablets of Gilead Sciences, Inc.

Tenofovir alafenamide is used to treat chronic hepatitis B virus (HBV) infection in patients with compensated liver disease.

The drug maker said that the product will be manufactured at its Nagpur facility in India.

According to IQVIA MAT December 2022 data, Tenofovir Alafenamide Tablets had estimated annual sales of $531 million in the U.S.

Meanwhile, Lupin announced that the United States Food and Drug Administration (USFDA) has issued Form 483, with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US drug regulator has inspected Lupin's Pithampur Unit-2 manufacturing facility from 21 March to 29 March 2023.

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 reported 71.9% drop in net profit to Rs 153.5 crore despite of 3.8% rise in net sales to Rs to Rs 4,244.6 crore in Q3 FY23 over Q3 FY22.

Shares of Lupin declined 0.76% to Rs 647.50 on the BSE.

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