The approved ANDA is a generic version of Gilead Sciences, Inc.’s Vemlidy Tablets. In patients with compensated liver disease, tenofovir alafenamide is used to treat chronic hepatitis B virus (HBV) infection. The drugmaker stated that the product will be manufactured in India at its Nagpur facility.
Tenofovir Alafenamide Tablets had an estimated annual sales of $531 million in the United States in December 2022, according to IQVIA MAT data.
Meanwhile, Lupin announced that the US Food and Drug Administration (USFDA) issued Form 483, containing ten observations, following an inspection of its Pithampur Unit-2 manufacturing facility. From March 21 to March 29, 2023, the US Food and Drug Administration inspected Lupin’s Pithampur Unit-2 manufacturing facility.
Lupin is a transnational pharmaceutical company based in Mumbai, India that focuses on innovation. The Company develops and commercialises a diverse range of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. Despite a 3.8% increase in net sales to Rs 4,244.6 crore in Q3 FY23 over Q3 FY22, the company reported a 71.9% drop in net profit to Rs 153.5 crore.