Suppliers and packagers for generic pharmaceutical drug: fexinidazole

fexinidazole

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi	FEXINIDAZOLE	fexinidazole	TABLET;ORAL	214429	NDA	Sanofi-Aventis U.S. LLC	0024-4512-14	14 TABLET in 1 DOSE PACK (0024-4512-14)	2021-07-16
Sanofi	FEXINIDAZOLE	fexinidazole	TABLET;ORAL	214429	NDA	Sanofi-Aventis U.S. LLC	0024-4512-24	24 TABLET in 1 DOSE PACK (0024-4512-24)	2021-07-16

Suppliers for the Pharmaceutical Drug: FEXINIDAZOLE

Last updated: July 29, 2025

Overview of Fexinidazole

Fexinidazole is a groundbreaking oral medication used primarily to treat Human African Trypanosomiasis (HAT), also known as sleeping sickness. Developed by Sanofi, fexinidazole is notable for its potential to eliminate the need for invasive treatments like intravenous arsenic-based therapies, thus simplifying management of this tropical disease. Its approval by regulatory agencies such as the European Medicines Agency (EMA) and the World Health Organization (WHO) underscores its significance in infectious disease therapy.[1]

Manufacturers and Licensed Suppliers

Initially, Sanofi held exclusive rights for the manufacturing and distribution of fexinidazole, given its status as an innovative pharmaceutical discovery. However, the complex landscape of drug manufacturing, licensing, and distribution has diversified suppliers over time, especially as generic production and local manufacturing initiatives emerge.

1. Sanofi

As the original developer, Sanofi remains the primary supplier and licensor of fexinidazole. The company oversees the manufacturing process, ensuring quality control, regulatory compliance, and global distribution.[2] Sanofi’s extensive infrastructure in pharmaceutical production enhances its ability to supply fexinidazole to markets worldwide, particularly in endemic regions in Africa.

2. Generic Manufacturers

With increased global health efforts, several generic pharmaceutical companies have obtained licensing or are in the process of establishing manufacturing capabilities for fexinidazole. These include:

• Macleods Pharmaceuticals: Based in India, Macleods has a history of producing quality generics for infectious diseases and has entered licensing agreements for fexinidazole to expand access in emerging markets.[3]

• Hetero Labs: An Indian-based pharmaceutical firm, Hetero has invested in developing bioequivalent formulations for neglected diseases, reportedly securing licensing rights to manufacture fexinidazole under approval from Sanofi or relevant health authorities.[4]

• Cipla: Another Indian manufacturer known for producing affordable medicines; Cipla is pursuing licensing options for fexinidazole with the potential to serve low- and middle-income countries (LMICs) effectively.[5]

3. Local Manufacturers in Endemic Regions

Efforts to decentralize production have led to collaborations with local manufacturers in Africa and other endemic regions. These manufacturers, often working under licensing agreements or technology transfer initiatives from Sanofi or approved generic firms, aim to improve supply chain resilience and reduce costs.

• Ethiopian Pharmaceutical Manufacturing Company (EPHARM): Nigeria’s government-aligned manufacturing enterprise is exploring production capabilities for fexinidazole to ensure local availability.[6]

• South African Manufacturers: Local pharmaceutical companies are engaged in technology transfer programs to facilitate regional manufacturing, bolstering drug access in Sub-Saharan Africa.

Regulatory and Supply Chain Dynamics

Obtaining reliable supply involves navigating multiple regulatory landscapes. For licensed generic manufacturers, approvals via national drug regulatory authorities (NDRAs) such as the Indian Central Drugs Standard Control Organization (CDSCO) are fundamental before market distribution. The WHO prequalification process also plays a pivotal role in ensuring quality, safety, and efficacy standards for procurement by international health agencies.[7]

The global initiative by WHO aims to facilitate the procurement of quality-assured fexinidazole for disease eradication programs. As of 2023, WHO prequalified fexinidazole produced under licensing agreements are the primary pathway to widespread distribution in endemic areas.[8]

Emerging Supply Sources and Biosimilar Development

While fexinidazole is a chemical small-molecule drug, efforts are underway in some regions to develop biosimilars and improved formulations, possibly expanding the supplier base further. Pharmacological research centers collaborating with pharmaceutical companies seek to optimize bioavailability, stability, and cost-effectiveness, fostering additional sources for supply in the future.

Market Access and Supply Challenges

Supply reliability hinges on factors like manufacturing scale-up, patent and licensing controls, geopolitical stability, and the capacity of generic firms to meet demand. Patent protections held by Sanofi could restrict immediate entry for competitors, though voluntary licensing and tiered pricing mechanisms help facilitate access.[9]

Furthermore, the logistical challenge of delivering medications to remote and conflict-affected zones remains a key issue. Strains in supply chains due to global disruptions—such as the COVID-19 pandemic—highlight the importance of diversified supplier sources and local manufacturing capacity.

Regulatory Trends Impacting Suppliers

The evolving regulatory landscape influences supplier options. Countries adopting the WHO prequalification standards and streamlining approval processes are more likely to receive timely supply from licensed manufacturers. Sanofi has maintained a proactive approach by obtaining approvals across multiple jurisdictions, whereas generic manufacturers are expanding their production rights in targeted regions.

Conclusion

The supplier ecosystem for fexinidazole is increasingly diversified, driven by licensure agreements, local manufacturing initiatives, and international health efforts. While Sanofi remains the primary global supplier, the involvement of Indian generics—Macleods, Hetero, and Cipla—alongside emerging local manufacturers in Africa, signifies a strategic move toward broader access and sustainable supply. Navigating regulatory channels and overcoming logistical hurdles are critical to ensuring continuous availability, especially in regions most affected by sleeping sickness.

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Key Takeaways

• Sanofi remains the predominant supplier of fexinidazole, holding licensing rights and overseeing global distribution.
• Multiple Indian generic manufacturers, including Macleods, Hetero, and Cipla, are licensed or poised to produce fexinidazole for affordable access in LMICs.
• Local manufacturing initiatives in Africa aim to augment supply chains, reduce dependency on imports, and enhance disease control efforts.
• Regulatory pathways like WHO prequalification are vital for expanding supplier participation and ensuring quality standards.
• Diversification of suppliers, coupled with robust licensing agreements and local manufacturing, is essential for meeting global demand and ensuring reliable access.

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FAQs

1. What is the primary source of fexinidazole?
Sanofi is the original developer and primary global supplier of fexinidazole, controlling manufacturing and licensing rights. Several licensed generic manufacturers are authorized to produce the drug under Sanofi’s oversight for specific markets.

2. Are there generic options for fexinidazole?
Yes. Several Indian pharmaceutical companies, including Macleods, Hetero, and Cipla, have secured licensing rights or are developing production processes, aiming to produce generic formulations for LMICs to improve access.

3. How does licensing influence the supply of fexinidazole?
Licensing agreements enable generic manufacturers to produce and distribute fexinidazole legally, increasing supply diversity, reducing costs, and expanding access in endemic regions.

4. What role does WHO prequalification play in fexinidazole supply?
WHO prequalification certifies the quality and safety of the drug, facilitating procurement by international agencies, and encourages manufacturers to meet global standards, thereby expanding supply options.

5. What challenges impact fexinidazole supply continuity?
Challenges include patent restrictions, manufacturing capacity limitations, regulatory approval delays, geopolitical instability, and logistical barriers in distributing the drug to remote areas.

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References

[1] World Health Organization. “Fexinidazole for sleeping sickness.” WHO. 2022.
[2] Sanofi. “Fexinidazole Development and Licensing Details.” Sanofi Corporate Website. 2023.
[3] Macleods Pharmaceuticals. “Partnerships and Licensing Agreements.” Macleods Official Site. 2023.
[4] Hetero Labs. “Investments in Tropical Disease Treatments.” Hetero Pharma Reports. 2023.
[5] Cipla. “Access Initiatives for Neglected Diseases.” Cipla Newsroom. 2023.
[6] Ethiopian Pharmaceutical Manufacturing Company. “Investment in Tropical Disease Medication Production.” EPHARM. 2022.
[7] WHO Prequalification Program. “Guidelines for Drug Approvals.” WHO. 2022.
[8] WHO. “Prequalification of Fexinidazole for Human African Trypanosomiasis.” WHO Status Report. 2023.
[9] International Federation of Pharmaceutical Manufacturers & Associations. “Patent and Licensing Strategies.” IFPMA Reports. 2022.