NEW YORK (September 12, 2025)—Lupin Limited, a leading pharmaceutical company headquartered in India, has been granted prequalification by the World Health Organization (WHO) for its 200mg tablet of pretomanid for use in the treatment of drug-resistant tuberculosis (DR-TB). WHO prequalification assures people with TB and healthcare providers that the product meets the highest standards of safety, quality, and efficacy.
Pretomanid, developed by the nonprofit TB Alliance, is a cornerstone of the six-month BPaL/M regimens that have transformed DR-TB treatment globally. Until recently, most DR-TB regimens required 9-18 months or more to complete and had significantly lower treatment success rates and higher pill burdens.
Through partnerships with Lupin and other manufacturers, TB Alliance is working to expand access to this life-saving treatment by ensuring an affordable, sustainable, and competitive market for all new TB medicines. Lupin will commercialize pretomanid across a wide range of countries, helping to meet global demand.
TB remains the world’s deadliest infectious disease. According to WHO, fewer than half of the estimated 400,000 people with DR-TB started treatment in 2023. With WHO prequalification, Lupin’s product will strengthen global efforts to close this treatment gap and provide more people impacted by TB with reliable access to modern, people-friendly and provider-friendly treatment.
WHO prequalification is essential for procurement by many United Nations agencies and international mechanisms such as the Global Fund and Stop TB’s Global Drug Facility, which support low- and middle-income countries. Lupin’s achievement ensures that these vital channels can now include its pretomanid in their supply of essential medicines for DR-TB.