Bulk Pharmaceutical API Sources for benznidazole

Bulk Pharmaceutical API Sources for benznidazole

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		419656_ALDRICH
Molport		MolPort-003-932-449
TimTec		ST069365
AKos Consulting & Solutions		AKOS015916722

Bulk Active Pharmaceutical Ingredient (API) Sources for: BENZNIDAZOLE

Last updated: August 7, 2025

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Introduction

Benznidazole stands as a cornerstone in the treatment of Chagas disease, an endemic parasitic illness primarily impacting Latin America. Recognized by the World Health Organization (WHO) as a critical medicine, its manufacturing and supply chain are pivotal for global health initiatives targeting neglected tropical diseases. Securing reliable sources for bulk API production ensures drug accessibility, quality, and affordability. This report delineates the leading suppliers and manufacturing paradigms for benznidazole API, analyzing their geographic distribution, scale, regulatory landscape, and strategic significance.

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Overview of Benznidazole API Production

Benznidazole, chemically known as 2-(4-nitroimidazol-1-yl)ethyl carbonate, is synthesized through multi-step processes involving nitroimidazole derivatives and subsequent purification. The complexity of synthesis, along with strict quality standards mandated by pharmacopoeias such as USP and EP, necessitates specialized manufacturing capabilities. Currently, API suppliers range from established multinational pharmaceutical producers to emerging regional manufacturers, primarily situated in Asia, Latin America, and Europe.

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Major API Manufacturers for Benznidazole

1. Chinese API Manufacturers

China remains the dominant source of cheap, high-volume APIs, including benznidazole. Several GMP-compliant factories operate at scale, catering predominantly to generic drug companies serving endemic markets and international contracts.

• Hunan Jifu Pharmaceutical Co. Ltd.

  • Specializes in manufacturing nitroimidazole derivatives.
  • Holds approvals from Chinese regulatory authorities and possesses WHO-GMP certification.
  • Capable of supplying bulk quantities suitable for large-volume distribution.

• Shenzhen Sino-American Pharmaceutical Technologies Co., Ltd.

  • Produces various antiparasitic APIs, including benznidazole.
  • Focuses on high-quality standards aligned with international regulatory requirements.

• Zhejiang Hezheng Pharmaceutical Co., Ltd.

  • Offers competitive pricing and scaled manufacturing options.
  • Complements their portfolio with other antiparasitic APIs, streamlining supply chains.

2. Indian API Suppliers

India's API manufacturing ecosystem emphasizes both high volume and regulatory compliance, with several companies holding WHO-GMP and USFDA approvals.

• Division of Central Drugs Laboratory, Mumbai

  • Recognized for synthetic capabilities in nitroimidazole compounds.
  • Supplies bulk API to international markets, including Latin America and Africa.

• Suwastha Life Sciences Ltd.

  • Focuses on antiparasitics, including benznidazole.
  • Compliant with global standards, serving emerging markets.

• Aurigene Pharmaceuticals Ltd.

  • Engaged in contract manufacturing of APIs, including benznidazole, for multinational clients.

3. Latin American and Regional Manufacturers

Given the endemic nature of Chagas disease in Latin America, regional manufacturers often produce benznidazole domestically to reduce costs and ensure rapid supply.

• Laboratorios Andromaco (Argentina)

  • Developed local manufacturing capacity for API as part of national health programs.
  • Ensures rapid deployment aligned with public health needs.

• LAPI (Laboratorios de Farmacia y Producción) in Peru

  • Focused on regional supply of antiparasitic APIs, including benznidazole.
  • Supports local distribution channels.

Quality and Regulatory Considerations

Quality assurance remains paramount when sourcing API, especially for essential medicines like benznidazole. Suppliers with WHO-GMP, EDQM, USFDA, or EMA certifications are preferred, as these standards ensure purity, potency, and consistent manufacturing processes. The complexity of synthesis and the sensitive nature of nitroimidazole chemistry demand rigorous quality controls, including HPLC purity assessments, microbiological testing, and impurity profiling.

Regulatory acceptance hinges on API dossiers, including batch records, stability data, and validation reports. Regional manufacturers often pursue certifications aligned with target markets to facilitate import and registration processes. For non-endemic countries or organizations engaging in manufacturing bulk supplies, ensuring API compliance with international standards mitigates regulatory risks.

Supply Chain and Strategic Sourcing Insights

The API supply chain for benznidazole is characterized by:

• Cost-competitiveness: Chinese manufacturers dominate in providing low-cost API, though concerns over quality and regulatory acceptance necessitate rigorous supplier audits.
• Regulatory status: Indian and Latin American manufacturers increasingly attain international certifications, broadening access for global players.
• Regional production: Latin American manufacturers bolster local supply, reducing dependency on imports and improving responsiveness during health crises.
• Dual sourcing strategies: Multinational companies often engage multiple suppliers to mitigate risks linked to supply disruptions, regulatory changes, or quality deviations.

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Emerging Trends and Future Outlook

• Capacity expansion: Existing manufacturers are investing in expanding GMP-compliant facilities to meet rising demand driven by Chagas disease control programs.
• Innovative manufacturing technologies: Continuous flow synthesis and alternative processes aim to improve purity and reduce production costs.
• Regulatory harmonization: Efforts by WHO, ICH, and regional authorities aim to streamline API approval processes, facilitating more seamless international procurement.

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Conclusion

Sourcing high-quality benznidazole API remains crucial for the sustainable treatment of Chagas disease globally. Leading suppliers include Chinese manufacturers with large-scale production capabilities, Indian companies with robust regulatory compliance, and Latin American regional producers ensuring local accessibility. Strategic sourcing should prioritize quality certifications, regulatory acceptability, and supply chain resilience to ensure consistent availability of this lifesaving API.

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Key Takeaways

• Chinese API manufacturers lead in volume and cost-efficiency, but suppliers with international certifications ensure compliance and acceptance in regulated markets.
• Indian suppliers are increasingly conforming to global standards, expanding their market reach.
• Regional Latin American producers provide critical local solutions, essential for rapid deployment in endemic areas.
• Quality assurance and regulatory compliance are non-negotiable criteria in API sourcing, impacting drug quality and market approval.
• Diversification of supplier base and strategic partnerships reduce supply chain risks for benznidazole API procurement.

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Frequently Asked Questions (FAQs)

1. What are the primary considerations when sourcing benznidazole API?
Quality standards (GMP compliance), regulatory approvals, manufacturing capacity, purity profile, and cost-effectiveness are paramount for sourcing reliable API.

2. Which countries dominate benznidazole API production?
China and India are the primary producers, with regional manufacturers in Latin America also supplying local markets.

3. How does API quality impact the efficacy of benznidazole?
High-purity API ensures the drug's safety, potency, and stability, directly affecting treatment outcomes and regulatory acceptance.

4. Are there any regulatory barriers in sourcing API from China or India?
Regulatory barriers depend on the certifying agencies' standards and the importing country’s requirements. Suppliers with WHO-GMP, USFDA, or EMA approvals facilitate smoother registration processes.

5. What trends are shaping the future of benznidazole API supply?
Capacity expansion, technological innovations in synthesis, increased regulatory harmonization, and regional manufacturing are shaping a resilient, compliant future supply chain.

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References

[1] World Health Organization. (2020). Chagas disease — global update.
[2] European Pharmacopoeia. (2021). Monograph on Nitroimidazoles.
[3] U.S. Food and Drug Administration. (2022). Approved Drug Master Files.
[4] Chinese State Food and Drug Administration. (2021). GMP certification standards.
[5] Indian Central Drugs Standard Control Organization. (2021). API manufacturing guidelines.

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Note: While this report highlights key suppliers and trends, ongoing due diligence and supplier audits are essential for establishing and maintaining secure, compliant API sourcing arrangements.