Suppliers and packagers for generic pharmaceutical drug: ARTEMETHER; LUMEFANTRINE
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ARTEMETHER; LUMEFANTRINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | COARTEM | artemether; lumefantrine | TABLET;ORAL | 022268 | NDA | Novartis Pharmaceuticals Corporation | 0078-0568-45 | 24 TABLET in 1 BOTTLE (0078-0568-45) | 2009-04-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Artemether-Lumefantrine
Introduction
Artemether-lumefantrine is a widely adopted combination therapy for malaria treatment, specifically for uncomplicated Plasmodium falciparum infections. As a crucial drug in combating malaria globally, especially in endemic regions, understanding its suppliers' landscape is vital for pharmaceutical companies, healthcare providers, and policymakers. This article offers an in-depth analysis of key suppliers, production dynamics, regulatory considerations, and market trends associated with artemether-lumefantrine.
Overview of Artemether-Lumefantrine
Artemether, a derivative of artemisinin, and lumefantrine, a synthetic partner, work synergistically to clear malaria parasites effectively. The drug's efficacy has made it a first-line treatment recommended by the World Health Organization (WHO) for uncomplicated malaria. Its production involves complex synthesis and quality assurance processes, subject to stringent regulatory standards.
Major Suppliers in the Global Market
1. Novartis AG
Leader in production and supply
Novartis has historically dominated the artemether-lumefantrine supply chain. The Swiss pharmaceutical giant markets the drug under the brand name Coartem, which is WHO prequalified. Novartis's manufacturing facilities in China and India ensure high-quality standards and supply consistency. Their patent and licensing agreements allow for broad distribution, especially in endemic regions via global health initiatives.
2. Sichuan Valid Pharmaceuticals (China)
Sichuan Valid Pharmaceuticals is a significant generic manufacturer supplying WHO-prequalified artemether-lumefantrine. The company's focus on malaria therapeutics enables it to produce large quantities at competitive prices, meeting procurement demands of international agencies. Their compliance with Good Manufacturing Practices (GMP) and certification standards has facilitated their inclusion in global procurement channels.
3. Guilin Pharmaceutical Co., Ltd. (China)
Guilin Pharma produces artemether-lumefantrine as part of its portfolio of antimalarial products. The company maintains WHO prequalification and adheres to international regulatory standards, enabling it to serve large-scale procurement programs across Asia, Africa, and Latin America.
4. Macleods Pharmaceuticals (India)
Macleods is a recognized producer of antimalarial drugs, including artemether-lumefantrine, with a significant market share in Asia and Africa. The company's strategic emphasis on affordable treatments aligns with global malaria eradication efforts. Its manufacturing plants are GMP-certified, ensuring quality through regulatory audits.
5. Cipla Limited (India)
Cipla manufactures generic artemether-lumefantrine formulations supplied to various nations. Cipla's extensive distribution network and commitment to affordable medicines make it a key player, especially in resource-constrained settings. Their WHO prequalification lends credibility to their products.
Market Dynamics and Regulatory Framework
WHO Prequalification and Regulatory Approvals
The primary criterion for suppliers in global procurement, especially through the Global Fund or UNICEF, is WHO prequalification. This process assesses the quality, safety, and efficacy of medicinal products. Manufacturers like Novartis, Sichuan Valid, and Guilin Pharma have achieved this status, enabling their products to be widely distributed in malaria-endemic regions.
Patent and Licensing Issues
While Novartis originally held patents on Coartem, many generic manufacturers now produce artemether-lumefantrine after patent expiration or through licensing agreements. These arrangements aim to lower prices, expand access, and promote local manufacturing.
Manufacturing Challenges and Quality Control
Manufacturing artemether-lumefantrine involves complex extraction and synthesis processes. Ensuring consistent quality requires rigorous adherence to GMP standards. Counterfeiting and substandard products remain significant hurdles, necessitating vigilant regulation and quality assurance from suppliers.
Emerging Suppliers and Market Trends
1. Indian and Chinese Pharmaceutical Companies
Should regulatory landscapes evolve or patents expire, new entrants from India and China are poised to increase supply. Companies like Hetero Labs and Aurobindo Pharma are investing in scalable synthesis processes, potentially expanding their market share.
2. Local Manufacturing Initiatives in Endemic Countries
Some malaria-endemic nations are developing local manufacturing capabilities for artemether-lumefantrine, reducing reliance on imports. Examples include facilities in Nigeria and Ethiopia, which could serve regional needs more efficiently.
3. Impact of Price Competition and Volume Procurement
Lower-cost generics are increasing access to treatment. International organizations’ bulk procurement strategies drive supplier competition, influencing prices and supply stability. The trend favors large-scale manufacturing and seamless supply chain management.
Regulatory and Supply Chain Considerations
- Licensing and Quality Assurance: Suppliers must maintain licensing agreements aligned with the WHO prequalification standards to participate in global health programs.
- Traceability and Counterfeit Prevention: Ensuring product authenticity remains critical. Suppliers leveraging serialization and track-and-trace solutions enhance supply chain integrity.
- Supply Chain Resilience: Diversification of suppliers mitigates risks related to geopolitical issues, manufacturing disruptions, or regulatory delays.
Conclusion
The supply chain for artemether-lumefantrine is characterized by a combination of established multinational companies like Novartis and a growing array of reputable generic manufacturers from China and India. Market dynamics favor cost-effective, quality-assured manufacturing, driven by global health needs and regulatory frameworks. Emerging suppliers and localized manufacturing efforts could reshape the landscape further, emphasizing the importance of supply chain resilience and regulatory compliance.
Key Takeaways
- Novartis remains the dominant supplier due to early innovation and WHO prequalification status.
- Major generics from China and India—such as Sichuan Valid, Guilin Pharma, Macleods, and Cipla—are essential to global supply, offering affordability and scalability.
- Adherence to WHO standards and GMP certification is crucial for supplier credibility and access to international procurement channels.
- Emerging local manufacturing initiatives promise to diversify the supply base and improve regional access.
- Business decisions should consider regulatory compliance, quality assurance, and supply chain robustness to mitigate risks of shortages or counterfeit incidents.
FAQs
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