In the fight against tuberculosis and malaria, two diseases that still kill more than two million people every year, the question of who manufactures the medicines matters as much as who discovers them. Macleods Pharmaceuticals, founded in Mumbai in 1989, holds more WHO-prequalified products than any other pharmaceutical company in the world — 65 and counting — making it the single most important supplier of essential medicines to the developing world’s public health systems.
Tuberculosis remains the world’s deadliest infectious disease, killing roughly 1.3 million people annually. The drugs that treat it are well understood — rifampicin, isoniazid, ethambutol, pyrazinamide — but the challenge is manufacturing them at a quality that meets international standards, at a price that the world’s poorest health systems can afford, and at a volume that serves hundreds of millions of patients.
Dr. Rajendra Agarwal, who built Macleods from a pharmacy in Jaipur into one of India’s largest pharmaceutical exporters, understood this challenge early. He directed the company toward anti-TB fixed-dose combinations — single tablets containing multiple active ingredients in precise ratios — and pursued WHO prequalification for each product. Of Macleods’ 65 WHO-prequalified products, 32 are anti-tuberculosis formulations. No other company comes close to this number.
The practical consequence is significant. When a national TB programme in sub-Saharan Africa or Southeast Asia tenders for first-line treatment, Macleods is almost always among the qualified bidders. The company’s anti-TB products are distributed through the Global Drug Facility, the Stop TB Partnership, and dozens of national procurement agencies. In certain African markets, Macleods is the dominant supplier of anti-TB medicines.
The story of Macleods is the story of three brothers — Dr. Rajendra Agarwal, Girdhari Lal Bawri, and Banwari Lal Bawri — who built a global pharmaceutical company from a standing start. Incorporated in 1989 with a focus on anti-infective medicines, the company grew steadily through the 1990s by targeting therapeutic categories that multinational companies considered too low-margin to prioritise: anti-TB drugs, anti-malarials, and basic antibiotics.
That strategic choice proved prescient. As global health funding expanded through the 2000s — via the Global Fund, PEPFAR, and bilateral aid programmes — demand for WHO-prequalified essential medicines grew dramatically. Macleods, which had invested years in building the regulatory dossiers and manufacturing quality systems required for prequalification, was positioned to capture that demand.
Revenue grew from approximately ₹5,870 crore to ₹7,199 crore by FY 2021, representing a compounded annual growth rate of nearly 11%. Growth continued through FY 2023 and FY 2024, with the company reaching an estimated ₹9,670 crore ($1.2 billion) in FY 2025. EBITDA grew 46% year-on-year in FY 2024, though margins moderated slightly in FY 2025 as the company invested in expanding its US generics portfolio.
Africa is where Macleods’ mission is most visible. The company has registered more than 1,000 products across the continent, with direct commercial operations in South Africa, Kenya, Nigeria, Uganda, Tanzania, and Ethiopia. In these markets, Macleods does not simply export and forget — the company maintains local regulatory teams, quality assurance staff, and distribution partnerships that ensure medicines reach the last mile.
The breadth of the African portfolio extends well beyond anti-TB and anti-malarial products. Macleods supplies cardiovascular medicines, anti-diabetics, respiratory therapies, dermatological products, and paediatric formulations across the continent. In many countries, Macleods brands are among the most recognised pharmaceutical names in government hospital pharmacies.
This depth of engagement — a thousand registered products, multiple therapeutic categories, direct presence in key markets — creates a compounding advantage. Each new product registration builds on existing regulatory relationships, distribution infrastructure, and brand recognition. It is the kind of market position that takes decades to build and is nearly impossible to replicate quickly.
Macleods operates in more than 170 countries, with eight major manufacturing units across India and a growing international footprint. The company’s facilities carry approvals from the US FDA, UK MHRA, WHO, and regulatory agencies in Europe, Africa, and Asia Pacific.
65 total WHO-prequalified products — highest of any pharmaceutical company globally
Macleods operates eight major manufacturing units across India — in Daman, Baddi (Himachal Pradesh), Sikkim, Indore, Sarigam, and Palghar — capable of producing oral solids, liquid orals, dry syrups, injectables, topicals, soft gelatin capsules, inhalers, and aerosols. Four facilities hold US FDA registration, and multiple sites are approved by the UK MHRA and WHO. The company holds 177 US FDA drug approvals (169 ANDAs, 8 NDAs) as of the most recent reporting period.
The manufacturing network is designed for versatility. The Sikkim facility alone produces solid orals, liquid orals, injectables, ointments, soft gels, and dry syrups — a range that allows Macleods to serve the full spectrum of dosage forms demanded by international health procurement agencies. This breadth, combined with the depth of the WHO-prequalified portfolio, makes Macleods a one-stop supplier for national health programmes in the developing world.
Sources: CARE Ratings Ltd credit report on Macleods Pharmaceuticals Limited (May 2024). Macleods Pharmaceuticals corporate website and annual reports. WHO Prequalification Programme product database. US FDA ANDA approval records and facility registration data. Indian patent office records.