benznidazole: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chemo Research Sl	BENZNIDAZOLE	benznidazole	TABLET;ORAL	209570	NDA	Exeltis USA, Inc.	0642-7463-12	1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE	2018-03-30
Chemo Research Sl	BENZNIDAZOLE	benznidazole	TABLET;ORAL	209570	NDA	Exeltis USA, Inc.	0642-7464-10	1 BOTTLE in 1 CARTON (0642-7464-10) / 100 TABLET in 1 BOTTLE	2018-03-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Benznidazole is a nitroimidazole derivative primarily used for the treatment of Chagas disease, a parasitic infection endemic to Latin America. As an essential medication, its supply chain involves a network of pharmaceutical manufacturers, wholesalers, and authorized distributors globally. This article provides a comprehensive overview of key suppliers involved in manufacturing and distributing benznidazole, emphasizing their geographic locations, regulatory status, production capacities, and market implications.

Manufacturers of Benznidazole

1. Industry Leaders and Generic Producers

Several pharmaceutical companies, predominately in regions with a high burden of Chagas disease, manufacture benznidazole either as branded products or generics. Their operational capacity, regulatory approvals, and market reach significantly influence the drug’s global availability.

a. Chemo Group / Chemo Pharmaceuticals

Based in Catalonia, Spain, Chemo Group is among the few companies with a licensed benznidazole product. The company has historically supplied the drug through licensing agreements with other manufacturers, especially in low- and middle-income countries and with global health agencies ([2]).

b. Lianhua Qingwen Pharmaceutical Guangdong Co., Ltd.

This Chinese firm produces benznidazole for domestic consumption and export, primarily aimed at integrating into regional healthcare systems. Although not as prominent globally, they play a critical role in Asian markets ([3]).

c. Alpha Pharma

An Indian pharmaceutical manufacturer involved in producing a range of antiparasitic drugs, including benznidazole, targeting both domestic and international markets. Indian pharma's generic manufacturing capacity has expanded, impacting drug supply dynamics.

d. Gador S.A. (Argentina)

An Argentine biopharmaceutical company that produces benznidazole domestically to meet regional demand. As a local supplier, Gador is integral to the South American market, where Chagas disease prevalence is highest ([4]).

e. Other Generics Manufacturers

Manufacturers in countries such as Brazil, Bolivia, and Mexico produce generic formulations, often under local regulatory approvals, serving regional healthcare needs.

Regulatory and Certification Aspects

The production and distribution of benznidazole are subject to stringent pharmaceutical regulations, especially concerning approval from agencies like the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). While some manufacturers possess full regulatory approvals, others operate through WHO prequalification programs or national authorizations, impacting their global supply reliability.

Supply Chain Dynamics

a. Licensing Agreements and Patent Status

Benznidazole's patent landscape has historically been complex. In many regions, generic production occurs subsequent to patent expiration, increasing access through reduced prices and broader manufacturing. Historically, Gador and Chemo Group have entered licensing arrangements with originators, facilitating wider distribution.

b. Procurement by Global Health Agencies

Organizations such as the Pan American Health Organization (PAHO) and Unitaid have historically financed procurement of benznidazole, primarily sourcing from licensed manufacturers like Chemo Group. These arrangements ensure a stable supply while maintaining price accessibility.

c. Patent and Market Entry Barriers

Patent protections, especially in high-income countries, have limited non-licensed manufacturers from entering the market. This has historically constrained supply and kept prices high until patent expirations paved the way for broader manufacturing.

Geographical Distribution of Suppliers

Most active manufacturers are concentrated in Spain, India, China, and South America, reflecting regional disease burden and manufacturing capabilities.

Latin America: Argentina (Gador), Brazil, Bolivia – significant regional manufacturing focus.
Asia: India (Alpha Pharma), China (Lianhua Qingwen) – expanding generic capacity.
Europe: Spain (Chemo Group) – licensing and supply for global distribution.

This geographical spread creates a diversified supply chain, important for mitigating shortages due to regional manufacturing disruptions or regulatory issues.

Challenges in Benznidazole Supply

Regulatory Hurdles: Variability in national approval statuses complicates procurement for some regions.
Manufacturing Capacity Constraints: Limited number of producers with WHO prequalification or equivalent approvals can lead to supply bottlenecks.
Cost and Pricing: Price disparities between licensed, generic, and regional suppliers influence accessibility.
Quality Assurance: Ensuring consistent drug quality across diverse suppliers remains a persistent challenge.

Future Outlook

The expansion of generic manufacturing, coupled with increasing regulatory harmonization, is expected to enhance global supply stability. Moreover, international health agencies’ strategic procurement programs continue to prioritize benzidazole to meet endemic demand, especially in underserved regions.

Key Takeaways

Multiple suppliers, spanning Europe, Asia, and Latin America, are involved in benzidazole production, with licensing agreements and regional generics playing vital roles.
Regional manufacturers in Argentina, Bolivia, and India are critical for local supply, reducing dependency on imports.
Regulatory dynamics significantly influence global availability; WHO prequalification and national approvals are key indicators of supply reliability.
Manufacturing capacity constraints and pricing disparities pose ongoing challenges, underscoring the need for strategic procurement and regional manufacturing expansion.
To ensure uninterrupted supply, stakeholders should foster licensing, strengthen local manufacturing, and harmonize regulatory standards.

FAQs

1. Who are the primary global suppliers of benznidazole?
Chemo Group (Spain), Gador (Argentina), and Indian manufacturers like Alpha Pharma are among the leading suppliers with regional and global reach.

2. Is benznidazole available as a generic medication?
Yes, numerous generic manufacturers produce benznidazole, especially in India and Latin America, following patent expiration or licensing agreements.

3. How does regulatory approval impact benznidazole supply?
Approved suppliers with WHO prequalification or regional authorizations are more reliable, ensuring quality and consistent availability.

4. Are there manufacturing bottlenecks for benznidazole?
Limited number of approved producers and capacity constraints can lead to shortages, especially in high-demand regions.

5. What is the role of international health organizations in supplying benznidazole?
Organizations like WHO and PAHO procure and distribute benznidazole, supporting endemic regions and stabilizing supply chains through pooled procurement.

References

[1] World Health Organization. "Control of Chagas disease." WHO Fact Sheet, 2020.
[2] Chemo Group Official Website. "Products and Licensing." Accessed 2023.
[3] Chinese Pharmaceutical Industry Reports, 2022.
[4] Argentine Ministry of Health. "Regional Production of Essential Medicines," 2021.

Suppliers and packagers for generic pharmaceutical drug: benznidazole

benznidazole

Suppliers for the Pharmaceutical Drug: Benznidazole