January 31, 2023: Lupin, headquartered in Mumbai, India, has received tentative approval from the FDA under the US President’s Emergency Plan for AIDS Relief for its New Drug Application for three drugs.
Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) tablets would be manufactured at Lupin’s Nagpur facility. DETAF would be a new addition in managing HIV infections and will be available for supplies to low- & middle-income countries.
“We are committed to providing affordable and quality treatment options to patients in low and middle-income countries,” said Naresh Gupta, President of API and Global Institution Business of Lupin.
“DETAF, which will significantly enhance our HIV portfolio,” according to a BSE filing.
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.
The company is one of India’s top pharmaceutical players in cardiovascular, anti-diabetic, and respiratory segments. It is significant in the anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin is the third-largest pharmaceutical company in the US by prescriptions. The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites and seven research centres.
Lupin reported annual sales of $2.2bn in FY22 when it invested 8.7% of its revenue in research and development.
Pharmaceuticals is a $22 billion market in India with an 11% compound annual growth rate, and Lupin has a 3.5% share of that pie, per the company’s January 11 investor presentation.
The market is projected to reach $30 billion by 2025 and $60-70 billion by 2030.