Bulk Pharmaceutical API Sources for DARAPRIM

Bulk Pharmaceutical API Sources for DARAPRIM

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-001-783-655
Hangzhou APIChem Technology		AC-7879
Amadis Chemical		A831755
AKos Consulting & Solutions		AKOS015892534
Oakwood Products		211965

Bulk Active Pharmaceutical Ingredient (API) Sources for Daraprim

Last updated: July 28, 2025

Introduction

Daraprim (pyrimethamine) is a critical antiprotozoal medication primarily used to treat toxoplasmosis and as part of combination therapy for certain types of malaria. Since its initial development, the global sourcing of its active pharmaceutical ingredient (API) has become increasingly vital due to the rising demand driven by infectious disease outbreaks and anti-parasitic treatment protocols. Ensuring a reliable, high-quality API supply chain is essential for pharmaceutical companies, healthcare providers, and regulatory bodies to meet patient needs while maintaining compliance with international standards.

This comprehensive analysis explores key sources of bulk API for Daraprim, analyzing manufacturing regions, supplier portfolios, regulatory considerations, and supply chain trends.

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Global Manufacturing Landscape for Pyrimethamine API

1. Dominant Production Regions

The primary regions responsible for the synthesis of pyrimethamine API include:

• India: India continues to be the dominant hub for generic pharmaceutical APIs, including pyrimethamine. Indian manufacturers leverage cost-effective production capabilities, extensive expertise in complex chemical synthesis, and an established export infrastructure to supply global markets.

• China: Chinese pharmaceutical API manufacturers have gained significant market share owing to technological advancements and aggressive scaling of production capacities. Many Chinese plants operate under strict compliance with Good Manufacturing Practices (GMP), fulfilling international standards.

• Eastern Europe: Smaller but notable producers exist in Eastern European countries like Hungary and Romania, often supplying European markets directly or through partnerships with global generic manufacturers.

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2. Leading API Manufacturers and Suppliers

The following companies are recognized for their API production capacities for pyrimethamine:

• Zhejiang Gurtin Pharmaceutical Co., Ltd. (China): An API manufacturer with extensive experience in synthesizing antiprotozoal agents, including pyrimethamine, supplying both domestic and export markets.

• Hetero Labs Limited (India): One of the largest Indian API producers with a diversified portfolio in anti-infective APIs, including pyrimethamine. Hetero adheres to strict GMP standards, and its APIs are used globally.

• Macleods Pharmaceuticals (India): Known for robust production capabilities across various anti-infective APIs, Macleods offers high-quality pyrimethamine API products to international markets.

• Biological E. Limited (India): Specializes in complex APIs, with additional focus on anti-parasitic APIs, including pyrimethamine APIs for generic formulations.

• Changzhou Kangpu Pharmaceutical Co., Ltd. (China): An emerging API producer with a focus on anti-infectives, offering competitively priced pyrimethamine API with GMP certification.

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3. Regulatory and Quality Standards

Suppliers in these regions predominantly aim to meet standards set by:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• World Health Organization (WHO) Prequalification
• Current Good Manufacturing Practices (cGMP) certifications

Global pharmaceutical companies prioritize sourcing from suppliers with reputable quality certifications, thorough validation procedures, and proven regulatory track records to mitigate risks and ensure compliance.

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Trends and Challenges in API Sourcing

1. Supply Chain Reliability

The COVID-19 pandemic highlighted vulnerabilities within global API supply chains, notably for critical drugs like pyrimethamine. Over-reliance on specific regions or a limited set of suppliers can create bottlenecks. Consequently, many manufacturers are adopting diversified sourcing strategies, including dual-sourcing and geographical diversification.

2. Regulatory Compliance and Due Diligence

Regulatory scrutiny has increased, especially regarding API manufacturing in China and India. Suppliers must demonstrate adherence to Good Manufacturing Practices (GMP), provide comprehensive regulatory documentation, and pass auditing processes for quality assurance before being approved for international export.

3. Carrier and Logistics Considerations

The transportation of APIs requires strict temperature controls, security measures, and documentation. Supply disruptions or regulatory restrictions can impact the timely procurement of pyrimethamine API, necessitating careful logistics planning.

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Future Outlook and Market Trends

• Increasing Demand from Global DONOR Agencies: WHO procurement programs and global health initiatives continue to bolster demand for pyrimethamine APIs, particularly in regions battling malaria and parasitic infections.

• Emerging Manufacturers and Contract Manufacturing Organizations (CMOs): The rise of regional CMOs offers new sourcing options, with some focusing on customizing API grades, including micronization or specific certifications.

• Sustainability and Green Chemistry: Suppliers are increasingly adopting environmentally sustainable manufacturing practices, driven by regulatory pressures and global sustainability commitments.

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Conclusion

Reliable sourcing of pyrimethamine API hinges on a robust network of manufacturers primarily located in India and China. Both regions supply high-quality APIs aligned with global standards, supported by a growing number of GMP-compliant producers. Businesses must conduct comprehensive due diligence, considering regulatory compliance, supply chain resilience, and quality assurance protocols.

Diversification of sources, investments in supplier validation, and leveraging suppliers with registered GMP certifications mitigate supply risks. As demand continues, strategic partnerships and transparent supply chains will remain essential to ensure continuous, high-quality API availability for Daraprim.

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Key Takeaways

• India and China dominate global pyrimethamine API production, with suppliers adhering to rigorous quality standards.
• Ensuring GMP compliance and regulatory transparency is critical when selecting API suppliers for Daraprim.
• Diversification and strategic planning are vital to mitigate supply chain vulnerabilities exacerbated by geopolitical and logistical challenges.
• The trend toward sustainable and environmentally friendly manufacturing practices reflects broader industry shifts and regulatory expectations.
• Ongoing global health initiatives will sustain or increase demand for pyrimethamine APIs, emphasizing the importance of reliable supply chains.

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FAQs

1. What factors should pharmaceutical companies consider when sourcing pyrimethamine API?
They should assess supplier GMP certifications, regulatory compliance, manufacturing capacity, quality control processes, and supply chain stability.

2. Are Chinese and Indian pyrimethamine API manufacturers meeting international standards?
Yes. Many are certified under cGMP, USP, and EP standards, with some obtaining WHO prequalification to ensure quality and compliance.

3. How has the COVID-19 pandemic affected the supply of pyrimethamine API?
It prompted supply chain disruptions, exposing over-reliance on specific regions. Companies are now diversifying supplier bases to mitigate risks.

4. What regulatory challenges exist for importing pyrimethamine API from Asian manufacturers?
Regulatory agencies scrutinize GMP compliance, manufacturing documentation, and product quality, requiring comprehensive validation before approval.

5. What is the future outlook for pyrimethamine API sourcing?
Continued growth in demand from global health programs, adoption of sustainable manufacturing practices, and the rise of regional CMOs will shape the API supply landscape.

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References

1. [1] Pharmaceutical Technology Asia. "API sourcing trends in India and China." 2022.
2. [2] World Health Organization. "Prequalification of medicines". 2022.
3. [3] U.S. Pharmacopeia. Standards for pyrimethamine API. 2021.
4. [4] European Pharmacopoeia. Monograph on pyrimethamine. 2022.
5. [5] Industry reports and company disclosures (publicly available annual reports and product catalogs).