Lupin Pharma gets tentative approval for Hepatitis B drug.

Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg. The approval allows Lupin to market a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated.

As per the company, the product will be manufactured at Lupin’s Nagpur facility in India. According to IQVIA MAT March 2022, the Ivacaftor Tablets had estimated annual sales of $109 million in the US.

Last month Lupin received tentative approval from US drug regulator for tenofovir alafenamide tablets used for treating chronic Hepatitis B infection. US FDA approved Tenofovir Alafenamide Tablets, 25 mg, to market a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc. (Gilead). The product is manufactured at Lupin’s Nagpur facility in India.

During FY22, the company invested 8.7 percent of its revenue in research and development. Lupin currently runs 15 manufacturing sites, 7 research centres, and more than 20,000 talent heads working globally. It has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology and Pharmaceuticals sector.

Lupin develops and commercializes 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. It is the third-largest pharmaceutical company in the US by prescriptions. The company invested 9.6 per cent of its revenue in research and development in FY21.

By NewsByts Team

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