Lupin receives tentative approval for Hepatitis B virus drug

Lupin on Monday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), tenofovir alafenamide tablets.

Tenofovir alafenamide tablets are used to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. The tablets are generic equivalent of Vemlidy tablets of Gilead Sciences, Inc. (Gilead).

According to IQVIA, Tenofovir Alafenamide tablets, had estimated annual sales of $484.2 million for the month of December 2021 in the United States.

Lupin said that the product will be manufactured at its Nagpur facility in India.

Lupin is a transnational pharmaceutical company. 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's consolidated net profit jumped 24.47% to Rs 545.52 crore on a 3.57% rise in total revenue from operations to Rs 4,160.93 crore in Q3 FY22 over Q3 FY21.

Shares of Lupin were trading 0.3% lower at Rs 770.05 on BSE.

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