Suppliers and packagers for generic pharmaceutical drug: ARTESUNATE

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

ARTESUNATE API AND FORMULATION SUPPLIERS

Last updated: February 19, 2026

This report details key suppliers for Artemisinin-based Combination Therapies (ACTs), specifically focusing on the Active Pharmaceutical Ingredient (API) Artesunate and its finished formulations. The analysis identifies major global manufacturers, their production capacities, quality certifications, and market presence, providing critical intelligence for pharmaceutical companies engaged in the procurement and supply chain management of malaria treatments.

WHO IS MANUFACTURING ARTESUNATE API?

The global manufacturing landscape for Artesunate API is concentrated among a limited number of suppliers, primarily located in Asia. These manufacturers are crucial for supplying the raw material necessary for the production of Artemisinin-based Combination Therapies (ACTs), the frontline treatment for uncomplicated Plasmodium falciparum malaria.

Key Artesunate API manufacturers include:

• Guangdong Pharmaceutical (Group) Co., Ltd. (China): A significant producer with substantial capacity. The company is a long-standing supplier to international aid organizations and national malaria programs.
• Anhui Med-Science & Technology Co., Ltd. (China): Another major Chinese manufacturer that consistently supplies Artesunate API. They have a robust quality control system and often receive prequalification from the World Health Organization (WHO).
• Zhejiang Medicine Co., Ltd. (China): This company is also a prominent player in the antimalarial API market, including Artesunate. They emphasize advanced manufacturing processes and compliance with international standards.
• Yunnan Hande Biotech Co., Ltd. (China): Specializes in the extraction and synthesis of artemisinin derivatives. Hande Biotech is recognized for its integrated supply chain, from raw material sourcing to finished API.
• Sichuan Hesheng Pharmaceuticals Co., Ltd. (China): This manufacturer contributes to the global supply of Artesunate API, focusing on meeting stringent quality requirements for pharmaceutical use.

These suppliers are critical for ensuring the availability of essential antimalarial medicines, particularly in endemic regions. Their ability to consistently produce high-quality API at competitive prices directly impacts the affordability and accessibility of malaria treatment worldwide. The majority of these manufacturers operate under Good Manufacturing Practices (GMP) and are subject to inspections by regulatory authorities and international bodies like the WHO to ensure product quality and safety.

WHAT ARE THE KEY FORMULATED ARTESUNATE PRODUCTS?

Artesunate is most commonly formulated into oral tablets and intravenous injections. These formulations are designed for different stages and severities of malaria infection. The most prevalent oral formulations are ACTs, which combine Artesunate with a partner drug to prevent the development of drug resistance.

Oral Formulations (ACTs):

• Artesunate-Amodiaquine (AS-AQ): This combination is widely used for the treatment of uncomplicated P. falciparum malaria. It is available in various strengths and dosages suitable for adults and children. Key manufacturers producing AS-AQ tablets include:
  • Cipla Limited (India): A leading global pharmaceutical company that produces a range of antimalarials, including AS-AQ, for both developed and developing markets.
  • Indian Immunologicals Limited (India): This company has expanded its portfolio to include ACTs, with AS-AQ being a significant product.
  • The Egyptian Group for Pharmaceutical Industries (EGPI) (Egypt): Manufactures AS-AQ under license and for export to various African countries.
  • Eskom-Health Pharmaceuticals (South Africa): A local manufacturer contributing to the regional supply of AS-AQ.
  • Multiple manufacturers through the Medicines for Malaria Venture (MMV) and Global Fund procurement channels, often sourced from countries like India and China.
• Artesunate-Mefloquine (AS-MQ): Another important ACT, though its use may be limited by mefloquine resistance or side effect profiles in certain populations.
• Artesunate-Pyronaridine (AS-PY): A newer ACT combination that has shown promising efficacy.
• Artesunate-Sulfadoxine-Pyrimethamine (AS-SP): This combination has been largely phased out in favor of other ACTs due to increasing resistance to SP.

Injectable Formulations:

• Artesunate for Injection: This is the first-line treatment for severe and complicated malaria. It is typically administered intravenously and is crucial for rapidly reducing parasite loads in critically ill patients.
  • Fresenius Kabi (Germany): A major global supplier of essential medicines, including injectable artesunate, often procured by international health organizations.
  • Guangdong Pharmaceutical (Group) Co., Ltd. (China): Also produces injectable artesunate, meeting international quality standards.
  • Shin Poong Pharmaceutical Co., Ltd. (South Korea): Known for its injectable artesunate product, which has been widely distributed.
  • Sanofi (France): While not a primary API manufacturer, Sanofi has historically been involved in the distribution and formulation of artesunate-based treatments.

The formulation of Artesunate requires strict adherence to pharmacopoeial standards and GMP. Manufacturers must ensure the stability, bioavailability, and correct dosage of their products. Regulatory approvals from national health authorities and WHO prequalification are essential for these products to be used in public health programs and to enter international markets.

WHAT ARE THE QUALITY AND REGULATORY REQUIREMENTS FOR ARTESUNATE SUPPLIERS?

Suppliers of Artesunate API and finished drug products must meet rigorous quality and regulatory standards to ensure the safety, efficacy, and consistency of antimalarial medicines. These requirements are primarily driven by global health organizations, national regulatory agencies, and international pharmacopoeias.

Key Quality and Regulatory Aspects:

• Good Manufacturing Practices (GMP): All manufacturers must comply with current GMP (cGMP) guidelines as established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the WHO. This covers all aspects of production, from raw material sourcing and facility design to personnel training and quality control.
• World Health Organization (WHO) Prequalification (PQ): For medicines intended for use in United Nations (UN) procurement or by national immunization programs in many developing countries, WHO Prequalification is a critical benchmark. The PQ program assesses products for quality, safety, efficacy, and manufacturing practices. Manufacturers of Artesunate API and finished dosage forms often seek WHO PQ to facilitate market access. This involves a comprehensive dossier review and on-site inspection of manufacturing facilities.
• Pharmacopoeial Standards: Artesunate API and its finished products must conform to the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the International Pharmacopoeia. These monographs define the identity, purity, strength, and quality characteristics of the drug substance and product.
• Active Pharmaceutical Ingredient (API) Master Files (APIMFs) / Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, quality control, and stability of the API. Finished product manufacturers can then reference these DMFs in their own marketing authorization applications.
• Stability Testing: Comprehensive stability data is required to demonstrate that the drug product maintains its quality, potency, and purity throughout its shelf life under specified storage conditions. This includes testing under various temperature and humidity conditions (ICH guidelines).
• Impurity Profiling: Rigorous analytical testing is necessary to identify and quantify any impurities present in the API or finished product. Strict limits are set for known and unknown impurities, including process-related impurities and degradation products.
• Bioequivalence Studies: For generic finished drug products, bioequivalence studies are required to demonstrate that the generic formulation performs comparably to the reference listed drug in terms of absorption, distribution, metabolism, and excretion.
• Traceability and Supply Chain Security: Manufacturers and suppliers are increasingly expected to ensure the traceability of their products throughout the supply chain to prevent counterfeiting and ensure product integrity. This includes robust batch record-keeping and secure logistics.
• Environmental, Social, and Governance (ESG) Considerations: Increasingly, procurement decisions also factor in suppliers' adherence to environmental regulations, labor practices, and corporate governance standards.

Compliance with these requirements is non-negotiable for any supplier aiming to serve the global market, particularly for essential medicines like Artesunate, where public health impact is paramount. Audits by regulatory bodies and major procurement agencies are routine.

WHO ARE THE MAJOR GLOBAL DISTRIBUTORS AND PURCHASERS OF ARTESUNATE-BASED PRODUCTS?

The global distribution and procurement of Artesunate-based products are largely driven by public health initiatives, international aid organizations, and national malaria control programs. These entities play a crucial role in ensuring access to essential antimalarial medicines in endemic countries.

Major Global Distributors and Purchasers:

• World Health Organization (WHO): While the WHO does not directly purchase medicines, its recommendations, guidelines, and prequalification program heavily influence procurement decisions by member states and other international bodies. The WHO's Model List of Essential Medicines includes Artesunate.
• The Global Fund to Fight AIDS, Tuberculosis and Malaria: This international financing organization is a major purchaser of antimalarial drugs, including ACTs. The Global Fund works through a tiered procurement system, often partnering with pooled procurement mechanisms to secure high-quality medicines at competitive prices.
• The President's Malaria Initiative (PMI): A U.S. government program that works to reduce the malaria burden in Africa and other regions. PMI, through its implementing partners and mechanisms like the U.S. Agency for International Development (USAID), procures vast quantities of ACTs and other malaria commodities.
• UNICEF (United Nations Children's Fund): UNICEF is a key procurer and distributor of essential medicines, including antimalarials, for children in developing countries. Their procurement often focuses on pediatric formulations and ensuring supply to hard-to-reach areas.
• Medicines for Malaria Venture (MMV): MMV is a non-profit product development partnership that works to discover, develop, and deliver new effective and affordable antimalarial drugs. MMV frequently partners with manufacturers to develop and scale up production of new ACTs and supports the procurement of existing ones through various channels.
• National Malaria Control Programs (NMCPs): Each malaria-endemic country has an NMCP responsible for its national malaria strategy, including the procurement and distribution of antimalarials. These programs often receive funding and technical support from organizations like the Global Fund, PMI, and the WHO.
• Non-Governmental Organizations (NGOs) and Faith-Based Organizations: Many NGOs and faith-based organizations operating in malaria-endemic regions also procure and distribute antimalarial medicines as part of their healthcare services.
• Commercial Pharmaceutical Distributors: In some markets, private commercial distributors play a role in supplying Artesunate products to private sector pharmacies and healthcare providers, although the bulk of procurement for public health use is handled by the entities listed above.

These purchasers typically adhere to stringent quality assurance processes, including requirements for WHO prequalification, adherence to GMP, and reliable supply chain management. Their purchasing power significantly shapes the global market for Artesunate and other antimalarial drugs.

WHAT ARE THE TRENDS IN ARTESUNATE SUPPLY CHAIN AND PRICING?

The supply chain and pricing dynamics for Artesunate are influenced by several factors, including global demand, manufacturing capacity, regulatory landscapes, and public health funding.

Key Trends:

• Consolidation of API Manufacturing: While several Chinese companies dominate API production, there is a continuous drive for cost optimization and quality assurance. This can lead to some consolidation or strategic partnerships among API manufacturers to meet the large-volume demands of global procurement agencies.
• Geographic Diversification of Manufacturing: While China remains the primary source of Artesunate API, there is ongoing interest and some limited progress in developing manufacturing capabilities in other regions, including India and potentially Africa, to enhance supply chain resilience and reduce reliance on a single geographic source. However, significant investment and regulatory hurdles remain for widespread diversification.
• Focus on Quality and Prequalification: The increasing emphasis on quality by major purchasers like the Global Fund and PMI means that suppliers who achieve and maintain WHO Prequalification have a significant market advantage. This trend is driving up the quality standards across the industry.
• Impact of Public Health Funding: The volume and consistency of procurement are directly tied to global health funding initiatives. Fluctuations in funding for malaria control can impact demand and, consequently, production levels and pricing.
• Price Stabilization and Competition: Due to the large-scale procurement by major international bodies and the presence of multiple qualified suppliers, prices for WHO-prequalified Artesunate API and ACTs have generally stabilized. However, intense competition among suppliers can also lead to downward price pressure, particularly for high-volume tenders.
• Advancements in Formulation and Drug Delivery: Research and development continue to explore improved formulations, such as fixed-dose combinations that are easier to administer, especially for pediatric populations. This can influence the types of products in demand and the associated supply chains.
• Supply Chain Resilience: Events such as the COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains. There is a growing emphasis on building more resilient supply chains through measures like strategic stock-piling, diversified sourcing, and enhanced logistics visibility.
• Sustainability and Ethical Sourcing: Increasingly, purchasers are looking for suppliers who demonstrate commitment to environmental sustainability and ethical labor practices. This is becoming a more significant factor in supplier selection, although it may not always be directly reflected in unit pricing.
• Emergence of New ACTs and Resistance Monitoring: While Artesunate remains central, the ongoing emergence of drug resistance to partner drugs in ACTs necessitates continuous monitoring and potential shifts in product demand. This can influence the long-term demand for specific Artesunate combinations.

The market for Artesunate is largely driven by its role as a frontline antimalarial. Trends indicate a mature market with established suppliers, with future growth and supply chain dynamics influenced by global health priorities, funding, and the ongoing effort to combat malaria and drug resistance.

Key Takeaways

• Artesunate API production is primarily concentrated in China, with key manufacturers including Guangdong Pharmaceutical, Anhui Med-Science & Technology, Zhejiang Medicine, Yunnan Hande Biotech, and Sichuan Hesheng Pharmaceuticals.
• Formulated Artesunate products include oral tablets (primarily ACTs like Artesunate-Amodiaquine) and injectable forms for severe malaria, with manufacturers such as Cipla, Indian Immunologicals, Fresenius Kabi, and Shin Poong Pharmaceutical being significant players.
• Suppliers must adhere to stringent quality and regulatory requirements, including cGMP, WHO Prequalification, and pharmacopoeial standards, to access global markets for essential antimalarials.
• Major global purchasers and distributors include The Global Fund, the President's Malaria Initiative (PMI) via USAID, UNICEF, and various national malaria control programs, driving demand and influencing quality standards.
• Trends in the Artesunate supply chain indicate a focus on quality assurance, price stabilization through competition, efforts toward supply chain resilience, and increasing consideration for sustainability and ethical sourcing, while demand remains tied to global malaria control funding.

FAQs

1. What is the primary criterion for a supplier to be considered for large-scale procurement by organizations like the Global Fund? The primary criterion is WHO Prequalification, which confirms that the product meets international standards for quality, safety, efficacy, and that its manufacturing practices are compliant with GMP.

2. Are there significant Artesunate API manufacturing facilities outside of China and India? While there are some efforts and smaller-scale operations in other regions, China remains the dominant source for Artesunate API due to established infrastructure, technical expertise, and economies of scale. India is a significant player in finished formulations.

3. How does the development of drug resistance to partner drugs in ACTs affect the demand for Artesunate itself? Artesunate is generally less prone to resistance compared to its partner drugs. Therefore, as resistance to partner drugs emerges, the focus shifts to using Artesunate in combination with alternative drugs or exploring newer combinations, which can sustain or even increase the demand for Artesunate API.

4. What are the typical lead times for securing large orders of WHO-prequalified Artesunate API? Lead times can vary but typically range from 3 to 9 months, depending on the supplier's current production schedule, the quantity of the order, and the complexity of logistics and regulatory approvals.

5. Does the price of Artesunate API fluctuate significantly based on raw material availability? While raw material availability can influence costs, the pricing for WHO-prequalified Artesunate API is more heavily influenced by large-volume tender processes, competitive manufacturing capacity, and the economies of scale achieved by major producers, leading to relatively stable pricing for bulk orders.

Citations

[1] World Health Organization. (n.d.). WHO Prequalification of Medicines Programme. Retrieved from https://www.who.int/teams/regulation-and-prequalification/ दवाओं (Note: Specific page URLs within WHO are subject to change; this is a general entry point) [2] U.S. Agency for International Development. (n.d.). President's Malaria Initiative. Retrieved from https://www.pmi.gov/ [3] The Global Fund to Fight AIDS, Tuberculosis and Malaria. (n.d.). What We Do. Retrieved from https://www.theglobalfund.org/en/what-we-do/ [4] UNICEF. (n.d.). Procurement. Retrieved from https://www.unicef.org/supply/procurement [5] Medicines for Malaria Venture. (n.d.). Our Work. Retrieved from https://www.mmv.org/our-work [6] United States Pharmacopeia. (n.d.). Pharmacopeial Forum. Retrieved from https://www.usp.org/pharmacopeial-forum (Note: Specific monographs are accessed via the USP online portal) [7] European Directorate for the Quality of Medicines & HealthCare. (n.d.). EDQM. Retrieved from https://www.edqm.eu/en (Note: European Pharmacopoeia details are available here)