Bulk Pharmaceutical API Sources for pyrimethamine; sulfadoxine

Bulk Pharmaceutical API Sources for pyrimethamine; sulfadoxine

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1208122
THE BioTek		bt-1546543
J&H Chemical Co.,ltd		JH278292
RR Scientific		R201500
EvitaChem		evt-1546543

Bulk Active Pharmaceutical Ingredient (API) Sources for Pyrimethamine and Sulfadoxine

Last updated: November 16, 2025

Introduction

Active Pharmaceutical Ingredients (APIs) form the chemical backbone of pharmaceutical formulations, enabling the development of effective medications. Pyrimethamine and sulfadoxine are critical antimalarial agents used in combination therapy for malaria treatment. The global supply chain for these APIs hinges on reliable sourcing, manufacturing quality, and regulatory compliance. This report explores the primary sources for bulk pyrimethamine and sulfadoxine, highlighting key manufacturers, regional concentrations, and supply chain considerations.

Overview of Pyrimethamine and Sulfadoxine

Pyrimethamine

Pyrimethamine is an antiparasitic agent primarily used to treat malaria by inhibiting dihydrofolate reductase enzyme activity. Its efficacy in combination therapies, notably with sulfadoxine, underscores its importance in malaria-endemic regions. The chemical complexity and synthesis pathway influence its production framework.

Sulfadoxine

Sulfadoxine is a sulfonamide antibiotic that inhibits dihydropteroate synthase, obstructing folic acid synthesis in parasites. Combined with pyrimethamine, it forms Fansidar, a widely used antimalarial drug. The synthesis involves specialized chemical reactions, influencing supplier selection and geographic sourcing.

Global Supply Chain Landscape

Regional Concentration of Manufacturing

The primary regions producing these APIs include India, China, and certain European countries. India and China dominate due to cost efficiencies, established chemical manufacturing infrastructure, and export capacity [1].

Regulatory and Compliance Standards

Manufacturers must comply with Good Manufacturing Practices (GMP), with certifications from regulatory agencies such as the U.S. FDA and European EMA. Quality issues can significantly disrupt supply chains and influence sourcing decisions.

API Suppliers for Pyrimethamine

Key Manufacturers and Their Capabilities

• Shandong Xinhua Pharmaceutical Co., Ltd. (China): Recognized for its robust API production, including pyrimethamine, with established GMP certification and export licenses.

• Hikma Pharmaceuticals (Jordan): A global generic manufacturer with a portfolio including pyrimethamine APIs, leveraging low-cost manufacturing and regulatory compliance.

• Hither Pharma (India): Noted for producing pyrimethamine API batches for global markets, with an emphasis on quality control and regulatory standards.

• Bachem AG (Switzerland): Specializes in custom synthesis and high-purity APIs, including pyrimethamine, mainly serving research and niche pharmaceutical markets.

Emerging and Niche Suppliers

• Cipla Limited (India): Active in API synthesis for antimalarials, including pyrimethamine, servicing developing countries.

• Venus Ethnopharm (India): Smaller-scale producer focusing on specialty APIs with flexible manufacturing.

Sourcing Considerations

Manufacturers sourcing pyrimethamine APIs should assess compliance with international GMP standards, supply chain stability, and their experience with antimalarial agents [2].

API Suppliers for Sulfadoxine

Leading Manufacturers and Capabilities

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A prominent sulfadoxine producer with large-scale manufacturing capacity and proven export compliance.

• BASF SE (Germany): Supplies high-quality sulfadoxine APIs, emphasizing strict quality control and consistency for global markets.

• Glenmark Pharmaceuticals (India): Produces sulfadoxine as part of its antimalarial API portfolio, with requisite quality certifications.

• Unichem Laboratories Ltd. (India): Offers sulfadoxine bulk APIs targeting both generic markets and research applications.

Regional Manufacturing Trends

Chinese manufacturing dominates due to its extensive chemical industry ecosystem and cost advantages. Indian producers complement this landscape with regulatory-compliant facilities targeting the global market [3].

Regulatory Challenges

Traceability of sulfadoxine API origins is crucial, with some markets requiring detailed documentation due to quality concerns historically associated with sulfonamide manufacturing. Suppliers with GMP certification and robust quality management systems are preferred.

Supply Chain Risks and Mitigation Strategies

Supply Disruptions

Dependence on a few key suppliers, geopolitical factors, and the COVID-19 pandemic have underscored vulnerabilities within the API supply chain. Diversification across multiple approved suppliers mitigates risks.

Quality Assurance

Due diligence on supplier GMP compliance, batch consistency, and certifications ensure API quality, reducing regulatory challenges downstream.

Intellectual Property and Regulatory Approvals

While pyrimethamine and sulfadoxine are off-patent, manufacturers must adhere to regional regulatory requirements, including environmental and safety standards, affecting source selection.

Emerging Trends and Future Outlook

The market anticipates increased API manufacturing in Africa and Southeast Asia, driven by regional governmental initiatives to reduce dependency on imports and facilitate local production. Additionally, advances in green chemistry may influence future manufacturing practices, emphasizing sustainability and cost-effectiveness.

Key Market Players Summary

Manufacturer	Region	API Focus	Certifications	Notable Strengths
Zhejiang Hisun Pharmaceutical	China	Sulfadoxine	GMP, ISO	Large-scale, established capacity
GSK (GlaxoSmithKline)	UK/Global	Pyrimethamine	EMA, FDA, GMP	Quality, regulatory experience
Hikma Pharmaceuticals	Middle East	Pyrimethamine	GMP, FDA	Cost-efficient production
BASF SE	Germany	Sulfadoxine	cGMP, ISO	High purity standards

Conclusion

The global sourcing landscape for pyrimethamine and sulfadoxine APIs is predominantly characterized by manufacturers in China and India, with select European firms serving as high-quality suppliers. Ensuring supply chain resilience demands rigorous supplier qualification, adherence to regulatory standards, and diversification. Emerging regional players and manufacturing innovations offer opportunities for increased stability, cost reduction, and improved drug security, particularly vital for malaria-endemic countries.

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Key Takeaways

• Chinese and Indian manufacturers dominate the pyrimethamine and sulfadoxine API markets, leveraging cost advantages and extensive manufacturing infrastructure.
• Regulatory compliance, particularly GMP certification, remains critical in supplier qualification to ensure product quality and market access.
• Supply chain risks necessitate diversification and active supplier management, especially amid geopolitical and pandemic-related disruptions.
• Emerging manufacturers in Africa and Southeast Asia present strategic opportunities but require rigorous quality and regulatory evaluation.
• Advances in green chemistry and manufacturing technologies are poised to influence future API production, emphasizing sustainability and efficiency.

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FAQs

Q1: Are there approved generic sources for pyrimethamine and sulfadoxine APIs?
Yes. Multiple manufacturers, especially in India and China, produce WHO-prequalified or GMP-certified APIs for both pyrimethamine and sulfadoxine, enabling generic formulations globally.

Q2: How can buyers verify the quality of APIs from these manufacturers?
Verification involves reviewing GMP certifications, batch compliance reports, audit histories, and third-party quality assessments. Engaging with trusted suppliers with existing regulatory approvals is recommended.

Q3: What are the primary regulatory considerations when sourcing these APIs?
Sourcing entities must ensure compliance with regional GMP standards, obtain necessary certifications, and verify documentation to meet import and registration requirements in target markets.

Q4: Are local manufacturing options feasible in malaria-endemic regions?
While possible, local manufacturing requires significant investment and robust regulatory infrastructure. Partnerships and technology transfer initiatives are potential avenues for establishing regional API production.

Q5: What future trends might affect the supply of pyrimethamine and sulfadoxine APIs?
Market shifts toward sustainable manufacturing, regional production initiatives, and advancements in chemical synthesis are anticipated to influence supply dynamics, potentially improving availability and reducing costs.

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References

[1] World Health Organization. (2022). Global Antimalarial Drug Market Overview.
[2] PharmSource. (2021). Global API Suppliers Directory.
[3] European Medicines Agency. (2022). Guidelines for API Manufacturing Quality Standards.