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Suppliers and packagers for generic pharmaceutical drug: artesunate
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artesunate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amivas | ARTESUNATE | artesunate | POWDER;INTRAVENOUS | 213036 | NDA | Amivas, Inc | 73607-011-11 | 2 KIT in 1 CARTON (73607-011-11) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (73607-002-01) * 1 SOLUTION in 1 VIAL (73607-003-02) | 2020-12-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ARTESUNATE
Introduction
Artesunate, an artemisinin derivative, is a cornerstone in the treatment of severe malaria, particularly caused by Plasmodium falciparum. Recognized for its rapid action and high efficacy, artesunate has become increasingly available through multiple suppliers—from multinational pharmaceutical companies to generic drug manufacturers and specialized importers. Ensuring quality, reliable supply sources, and understanding global distribution channels are crucial for healthcare providers, governments, and procurement agencies engaged in malaria treatment programs worldwide.
Overview of Artesunate
Artesunate is a semi-synthetic derivative of artemisinin produced primarily through chemical synthesis or extraction from Artemisia annua plants. Approved by various health authorities including the WHO, it forms part of combination therapies (ACTs) or used as monotherapy in certain regions. Its use spans both injectable formulations for severe cases and oral tablets for uncomplicated malaria. The demand for artesunate is driven by ongoing malaria burdens, especially in sub-Saharan Africa, Southeast Asia, and Latin America.
Major Global Suppliers of Artesunate
1. Pharmaceutical Giants and Licensed Manufacturers
Several established pharmaceutical companies possess manufacturing licenses for artesunate, often accredited by regulatory agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or WHO prequalification programs.
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Hetero Labs Limited (India): A leading producer of artesunate, Hetero supplies both injectable and oral formulations to global health organizations and governments. Their manufacturing facilities are WHO prequalified, ensuring adherence to strict quality standards (source: WHO PQ).
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Sanofi (France): Through its malaria-focused portfolio, Sanofi supplies artesunate formulations, especially targeting Africa. Sanofi’s focus on quality assurance has made it a preferred choice for large procurement agencies.
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Shanghai Epochem (China): A significant market player, Shanghai Epochem produces various artemisinin derivatives, including artesunate, with exports to multiple regions, including Africa and Southeast Asia. They hold multiple quality certifications relevant to global drug approval standards.
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Farmanguinhos (Fiocruz) (Brazil): As part of Brazil’s Oswaldo Cruz Foundation, Farmanguinhos manufactures artesunate for national use and export, often aligned with WHO prequalification and Brazil’s regulatory standards.
2. Generic and Local Manufacturers
Generic pharmaceutical firms have increased their presence in artesunate production to meet global demand, especially in resource-limited settings.
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Cipla Limited (India): Cipla produces both injectable and oral artesunate formulations, widely distributed across Africa and Asia. Cipla’s manufacturing complies with international quality standards, and the company’s products are often included in WHO-prequalified lists.
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Madaus (now part of Sanofi): Historically an advocate for artemisinin derivatives, Madaus contributed to the early supply chain efforts in Africa through quality assured generics.
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Zhejiang Jiuxu Medical Technology Co., Ltd. (China): A newer player expanding rapidly in the Asian and African markets, offering affordable artesunate formulations compliant with international standards.
3. Procurement through International Agencies
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World Health Organization (WHO): The WHO prequalifies artesunate manufacturers, ensuring procurement agencies can source from reliable suppliers. The WHO Essential Medicines List (EML) includes artesunate, further directing procurement policies and supply chain management.
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Medicines for Malaria Venture (MMV): MMV collaborates with manufacturers to develop and support supply of artesunate and related drugs, often facilitating licensing agreements and technology transfers.
Regulatory and Certification Landscape
To ensure drug quality, procurement agencies prioritize suppliers with WHO prequalification status or equivalent certifications. Prequalification signifies compliance with Good Manufacturing Practices (GMP), bioequivalence, and quality testing.
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WHO Prequalification Program: It assesses manufacturing quality, regulatory compliance, and bioavailability. Suppliers such as Hetero, Cipla, and Shanghai Epochem hold such certification for artesunate.
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EMA & FDA Approval: While less common for low-cost generics, some brands are approved in these jurisdictions, facilitating procurement for developed nations or emergency stockpiles.
Regional Supply Chain Dynamics
Africa
African governments and NGOs predominantly source artesunate from WHO-prequalified manufacturers, favoring suppliers like Hetero and Cipla. Local production capacities are emerging in countries like Nigeria and Kenya, aiming to reduce dependency on imports.
Asia
India and China dominate the supply of artesunate, with companies such as Hetero, Zhejiang Jiuxu, and Shanghai Epochem supplying both domestic and export markets.
Latin America
Brazil’s Farmanguinhos supplies artesunate primarily for regional use, aligned with national health policies and WHO standards.
Emerging Trends and Supply Challenges
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Genericization and Cost Factors: The increasing number of generic manufacturers has driven down prices, improving access but raising concerns over quality enforcement.
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Supply Chain Disruptions: Political instability, manufacturing bottlenecks, and global health crises (e.g., COVID-19) have impacted artesunate availability.
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Technology Transfer & Local Manufacturing: Efforts are underway to promote local production in malaria-endemic regions to improve supply resilience.
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Regulatory Harmonization: Advances in international regulatory cooperation aim to streamline approval processes, facilitating faster access to quality artesunate.
Regulatory Considerations for Buyers
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Verify WHO Prequalification: Essential for procurement under global health initiatives.
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Compliance with Local Regulations: Ensure suppliers meet national regulatory standards and import requirements.
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Quality Assurance: Regular testing and batch verification are critical for maintaining treatment efficacy and patient safety.
Conclusion: Navigating Artesunate Suppliers
The global landscape for artesunate is characterized by a mix of established pharmaceutical giants and agile generic manufacturers. For procurement agencies and healthcare providers, prioritizing WHO prequalified sources is crucial for ensuring drug quality and supply reliability. Collaboration with international organizations and embracing local manufacturing initiatives can mitigate supply disruptions and reduce costs.
Key Takeaways
- The primary suppliers of artesunate include WHO-prequalified companies such as Hetero (India), Cipla (India), and Shanghai Epochem (China).
- WHO prequalification is essential for assured quality and access, especially in low-resource settings.
- The supply chain is influenced by regional manufacturing capacities, regulatory environments, and global health policies.
- Emerging local manufacturing initiatives in malaria-prone regions aim to enhance supply resilience.
- Procurement strategies should incorporate rigorous quality assessments and align with international standards to ensure safe, effective malaria treatment.
FAQs
1. Why is WHO prequalification important for artesunate suppliers?
WHO prequalification ensures that artesunate manufacturers comply with international quality standards, including GMP, bioequivalence, and safety, which is critical for reliable procurement and patient safety.
2. Which countries dominate the production of artesunate?
India and China are the primary manufacturing hubs, with companies like Hetero and Shanghai Epochem leading the export of artesunate formulations globally.
3. Can local manufacturers in malaria-endemic countries produce artesunate?
Yes, some countries are establishing local production capacities through technology transfer and public-private partnerships, aiming to secure supply chains and reduce reliance on imports.
4. What role do international agencies play in artesunate supply?
Organizations such as WHO and MMV facilitate procurement, prequalification, and licensing, ensuring that artesunate reaching malaria patients worldwide meets quality standards.
5. How have recent global health challenges affected artesunate supply?
Disruptions caused by COVID-19 and geopolitical factors have affected manufacturing and logistics, emphasizing the need for diversified, resilient supply chains and local production development.
References
[1] World Health Organization. (2022). Prequalification of Medicines Programme.
[2] Medicines for Malaria Venture. (2023). Artemisinin-based Combination Therapies (ACTs).
[3] Hetero Labs Limited. (2022). WHO PQ Certification Document.
[4] Cipla Limited. (2023). Product Portfolio & Certifications.
[5] Shanghai Epochem. (2022). Export and Certification Details.
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