COARTEM: Pharmaceutical manufacturers, suppliers, and packagers

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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

Last updated: August 8, 2025

Introduction

COARTEM, a widely prescribed antimalarial medication, combines artesunate and mefloquine to provide an effective treatment against Plasmodium falciparum, the parasite responsible for the most lethal form of malaria. Developed by the pharmaceutical giant Novartis, COARTEM (also branded as Coartem or Artemether-Lumefantrine in some markets) plays a pivotal role in global malaria eradication efforts. As demand for this medication increases, understanding its suppliers becomes crucial for stakeholders across governments, healthcare providers, and procurement agencies.

This analysis offers a comprehensive overview of the key suppliers and manufacturing sources for COARTEM, analyzing their roles in the pharmaceutical supply chain, regulatory compliance, manufacturing capacity, and challenges.

Manufacturing and Supply Chain Overview

Novartis – The Original Manufacturer

Novartis has been the primary manufacturer and authorized supplier of COARTEM since its initial approval. The drug was developed as part of Novartis’ commitment to increasing access to essential medicines for neglected tropical diseases. Novartis's manufacturing facilities adhere to strict Good Manufacturing Practices (GMP) standards, ensuring product quality, safety, and efficacy.

Although Novartis supplies COARTEM globally, the company has established partnerships and licensing agreements to expand access, especially in malaria-endemic regions, under initiatives like the Affordable Medicines Facility–malaria (AMFm).

Generic Manufacturers and Licensing Agreements

The complex pharmaceutical landscape involves multiple generic manufacturers, especially in low- and middle-income countries (LMICs). Following patent expiry or licensing agreements, Novartis has authorized several manufacturers to produce generic versions of COARTEM to address supply shortages and reduce costs.

Key licensed generic producers include:

Shanghai Pharmaceutical Group (SPH) – China-based manufacturer producing Coartem under license, primarily for the Asian markets.
Milpharma (India) – A prominent producer supplying affordable versions of artemisinin-based combination therapies (ACTs), including Coartem.
Generics Pharmaceuticals – Various manufacturers in India and Bangladesh with licensing agreements to produce generic Coartem for Africa and other regions.

WHO Prequalification and Quality Assurance

The World Health Organization (WHO) prequalifies certain manufacturers to ensure that their products meet international standards. Currently, only select suppliers of COARTEM have achieved WHO prequalification, which is essential for procurement by UN agencies and national governments.

WHO Prequalified Suppliers:

Novartis Pharmaceuticals Corporation
MediPharm Labs (India)
Glenmark Pharmaceuticals (India)

The prequalification process assesses manufacturing quality, stability, bioequivalence, and packaging standards.

Regional Suppliers and Market Dynamics

Africa and Asia

In Africa, where malaria burden is highest, procurement primarily involves:

Novartis – Direct supplies to endemic countries with prequalified products.
Indian generic manufacturers – Supplying affordable alternatives and expanding access via licensing.

In Asia, particularly Southeast Asia and China, domestic manufacturers produce COARTEM and other artemisinin-based combinations, often supported by government initiatives or local partnerships.

Price and Accessibility Considerations

Pricing dynamics influence supplier choices. Novartis initially set high prices but has gradually reduced costs through licensing and global health initiatives. Generic manufacturers, particularly in India and Bangladesh, supply low-cost COARTEM, making treatment accessible in resource-limited settings.

Regulatory and Patent Landscape

Novartis held patents on the active ingredients and formulations of COARTEM. However, patent expiration in several jurisdictions has allowed generic manufacturers to produce biosimilar versions, subject to licensing agreements.

Regulatory challenges include:

Ensuring bioequivalence and quality compliance across diverse manufacturing sites.
Navigating patent laws and intellectual property rights to facilitate licensing.
Meeting WHO and national regulatory standards for registration and approval.

Challenges in the Supply Chain

Quality assurance: Ensuring that generic suppliers maintain the same safety and efficacy standards as the original manufacturer.
Supply disruptions: Manufacturing delays, shortages of raw materials, or logistical issues can impact supply.
Intellectual property disputes: Patent protections may delay or restrict generic entry.
Pricing pressures: Balancing affordability with sustainable manufacturing models.

Innovations and Future Directions

Emerging trends include:

Enhanced licensing models: Novartis and other originators increasingly adopt voluntary licensing strategies to expand distribution.
Localized production: Growing capabilities within endemic regions to reduce dependence on imports.
Investment in raw material supply chains: Securing artemisinin and mefloquine raw materials reduces vulnerability to supply variability.
Digital quality monitoring: Use of blockchain and IoT for real-time quality assurance.

Key Takeaways

Primary Manufacturer: Novartis remains the main supplier of authorized and prequalified COARTEM globally, leveraging global supply agreements and licensing.
Generic Suppliers: Licensed generic manufacturers, mainly in India and Bangladesh, play a critical role in increasing affordability and local access.
Quality Assurance: WHO prequalification of certain suppliers is essential for procurement confidence, emphasizing the importance of regulatory compliance.
Supply Chain Dynamics: Pricing, patent rights, and manufacturing capacity directly influence availability, especially in high-burden regions.
Future Outlook: Diversification through licensing, local manufacturing, and innovations in supply chain management will be vital to meet global malaria eradication goals.

FAQs

1. Who are the main suppliers of COARTEM globally?
The primary supplier is Novartis, which supplies the drug through direct manufacturing and licensing arrangements. Several licensed generic manufacturers, particularly in India and Bangladesh, contribute to global supply, especially in resource-limited regions.

2. What role does WHO prequalification play for COARTEM suppliers?
WHO prequalification certifies that manufacturers meet international standards for quality, safety, and efficacy, enabling procurement by global health organizations like UNICEF and WHO, and fostering confidence in supplied medicines.

3. Are there any patent restrictions on COARTEM, and how do they affect supply?
Novartis held patents on certain components until expiration in many jurisdictions, enabling generic manufacturers to produce biosimilars under licensing agreements. Patent expiration facilitates increased generic supply but has been subject to legal and regulatory considerations.

4. How are costs of COARTEM being managed to improve access?
Novartis has employed licensing agreements and tiered pricing strategies, supported by initiatives such as AMFm, to reduce costs and expand access, particularly in endemic and resource-limited settings.

5. What challenges do suppliers face in the production of COARTEM?
Key challenges include maintaining consistent quality standards across manufacturing sites, supply chain disruptions, securing raw material supplies, regulatory compliance, and navigating intellectual property rights.

References

[1] WHO Prequalification Programme. (2022). Artemether-Lumefantrine (Coartem). World Health Organization.

[2] Novartis. (2022). Coartem (artemether-lumefantrine): The Fight Against Malaria. Novartis Annual Report.

[3] Global Fund. (2021). Malaria Treatment and Procurement Overview. Global Fund to Fight AIDS, Tuberculosis and Malaria.

[4] Drugs for Neglected Diseases Initiative (DNDi). (2020). Affordable Access to Antimalarial Medicines. DNDi Reports.

[5] USAID. (2021). Supply Chain Innovations in Malaria Treatment. Malaria Control Program Report.

Suppliers and packagers for COARTEM

COARTEM

Suppliers for the Pharmaceutical Drug: COARTEM