INDIA – The U.S. Food and Drug Administration (FDA) has approved generic human immunodeficiency virus (HIV) antiretroviral drugs developed by Lupin Limited (Lupin).
Lupin, a leading global pharmaceutical company in India, announced that the FDA has cleared its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets.
In a press release, the global pharma major underscored: “Dolutegravir and Rilpivirine are antiretroviral medications to treat HIV/AIDS infection.”
Lupin pointed out that its novel HIV medicines will be available in the form of hard capsules in strengths of 25 mg, and 50mg.
The Indian manufacturer further said that its newly launched tablets are the generic equivalents of Juluca Tablets produced by ViiV Healthcare, a pharmaceutical company specializing in the development of therapies for HIV infection.
In addition, the Indian company has expanded its diverse portfolio in the cardiovascular, anti-diabetic, and respiratory segments with the launch of its novel HIV antiretroviral tablets.
Lupin underscored that its fixed-dose combination of Dolutegravir and Rilpivirine had estimated annual sales of US$666 million in the United States market.
The Mumbai-based pharmaceutical company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets.
It also has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
Its key markets include in the United States, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
In addition, Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and it is an internationally renowned company in the Biotechnology & Pharmaceuticals sector.
The FDA approval of Lupin’s HIV antiretroviral drugs comes weeks after the manufacturer launched its Regional Reference Laboratory in Indore, Madhya Pradesh, as part of its expansion in Central India.
Its subsidiary Lupin Diagnostics, founded in October 2021, provides comprehensive range of diagnostic services to doctors, patients, and consumers.
Lupin Diagnostics is well-equipped with world-class equipment, experienced doctors assisted by trained technologists and stringent quality control protocols.
Furthermore, its expansion into Indore is well-aligned with Lupin Diagnostics’ commitment to improving access to high-quality, reliable, and advanced testing centres and home collection facilities at an affordable price.