Last updated: February 20, 2026
Which manufacturers produce Pyrimethamine?
Pyrimethamine is an antiprotozoal medication primarily used for treating malaria and toxoplasmosis. It is available through multiple generic drug manufacturers and select branded suppliers globally.
Major suppliers include:
- Hetero Labs Ltd. (India): One of the largest producers, supplying both APIs and finished dosages.
- Moldavo Pharmaceutics (Moldova): Offers bulk API manufacturing.
- Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Produces API for both domestic and international markets.
- Aurobindo Pharma (India): Offers both API and finished dosage forms.
- Glenmark Pharmaceuticals (India): Supplies API and formulations.
- Cipla Limited (India): Supplies Pyrimethamine through APIs and formulations.
- Rajasthan Antibiotics Ltd. (India): Provider of bulk API.
API Manufacturers and Market Share
| Manufacturer |
Headquarters |
API Production Capacity |
Market Presence |
Notes |
| Hetero Labs Ltd. |
India |
200+ tons/year |
Global, especially Asia |
Largest Indian producer |
| Zhejiang Hisun Pharmaceutical |
China |
150+ tons/year |
Asia, Latin America |
Focus on exports |
| Moldavo Pharmaceutics |
Moldova |
50+ tons/year |
Europe, Middle East |
Regional supplier |
| Aurobindo Pharma |
India |
100+ tons/year |
Global |
Integrated API & formulations |
| Glenmark Pharmaceuticals |
India |
80+ tons/year |
Asia, Africa |
Expanding globally |
Branded and Generic Market Distribution
Pyrimethamine is supplied under various brand names and as a generic product. It is included in combination therapies for malaria.
Specific branded suppliers include:
- Daraprim (Terapir, USP): Originated in the United States, marketed by Vyera Pharmaceuticals.
- Fansidar (combination pill): Contains pyrimethamine and sulfadoxine; produced mostly in India and China.
- Several generic versions are produced by Indian and Chinese companies, often as APIs or finished drugs.
Regulatory Status and Supply Security
- The API is listed in WHO's Essential Medicines List.
- India and China are dominant in API production, with strict GMP standards.
- Supply chains are vulnerable to geopolitical and pandemic-related disruptions, impacting availability and pricing.
Geographic Considerations for Procurement
- Markets relying on Indian and Chinese suppliers should verify GMP certification and export licenses.
- Midsize to large pharmaceutical companies prioritize suppliers with proven batch consistency and regulatory compliance.
- Some suppliers provide custom synthesis, producing Pyrimethamine tailored to specific dosage forms and purity standards.
Key Takeaways
- The leading API producers are Indian and Chinese companies with capacities exceeding 80 tons annually.
- Pyrimethamine is available as a generic from numerous suppliers, with branded options like Daraprim.
- API supply chains are concentrated geographically, raising potential risks related to geopolitical instability or production disruptions.
- Suppliers must meet stringent regulatory standards for quality assurance and GMP compliance for international markets.
FAQs
1. Who are the top API producers for Pyrimethamine world-wide?
Hetero Labs (India), Zhejiang Hisun Pharmaceutical (China), Aurobindo Pharma (India), and Moldavo Pharmaceutics (Moldova).
2. Are there branded formulations of Pyrimethamine?
Yes, Daraprim is a well-known branded formulation; other brands exist depending on the region.
3. Which countries dominate Pyrimethamine API production?
India and China dominate API manufacturing, accounting for the majority of global supply.
4. What are the regulatory requirements for suppliers?
Suppliers must obtain GMP certification, comply with local and international pharmaceutical safety standards, and ensure batch consistency.
5. How does supply chain risk impact product availability?
Concentration in Asian manufacturing hubs can cause shortages if geopolitical, pandemic, or regulatory issues occur, affecting global supply stability.
Citations
[1] World Health Organization. (2023). WHO Model List of Essential Medicines.
[2] Indian Ministry of Chemicals & Fertilizers. (2022). API manufacturing standards.
[3] U.S. Food and Drug Administration. (2023). GMP compliance guidelines.
[4] European Medicines Agency. (2023). Pharmaceutical quality standards.
[5] MarketWatch. (2023). Global API market overview.
