Suppliers and packagers for ALBENZA

ALBENZA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax Labs Inc	ALBENZA	albendazole	TABLET;ORAL	020666	NDA	Amneal Pharmaceuticals of New York LLC	0115-1701-49	2 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49)	1996-06-11
Impax Labs Inc	ALBENZA	albendazole	TABLET;ORAL	020666	NDA	Amneal Pharmaceuticals LLC	64896-693-49	2 TABLET, FILM COATED in 1 BOTTLE (64896-693-49)	1996-06-11

Suppliers for the Pharmaceutical Drug: ALBENZA

Last updated: July 30, 2025

Introduction

Albenza (generic name: albendazole) is a broad-spectrum anthelmintic used primarily for treating parasitic infestations, including infections caused by tapeworms, roundworms, and other helminths. Since its approval, the drug has become a critical component of ant parasitic therapy globally. Ensuring a reliable supply chain for Albenza requires understanding its manufacturing landscape, the key suppliers involved, and the factors influencing supply stability. This analysis examines major suppliers, manufacturing principles, and the strategic landscape surrounding Albendazole production.

Manufacturers and Primary Suppliers

The production of Albenza (albendazole) involves several key pharmaceutical manufacturers, primarily concentrated in countries with robust generic drug manufacturing capabilities. These firms often operate under licensing agreements with patent holders or produce generic versions post-patent expiry. The principal suppliers include:

1. GlaxoSmithKline (GSK)

Initially developed by SmithKline Beecham, Albendazole was subsequently licensed to various manufacturers. GSK has historically been a notable producer, especially in original formulations, although mass manufacturing has shifted toward generic producers following patent expiration.

2. Teva Pharmaceutical Industries Ltd.

A dominant global player in generic pharmaceuticals, Teva supplies Albendazole in numerous markets, including the US, Europe, and Asia. Their extensive manufacturing infrastructure enables high-volume production, vital for addressing global healthcare needs.

3. Cadila Healthcare / Zydus Cadila

An established Indian pharmaceutical company, Zydus Cadila produces generic albendazole tablets, actively supplying to emerging markets and some developed regions, leveraging India’s robust generic manufacturing ecosystem.

4. Sanofi-Aventis / Sanofi

Sanofi has produced albendazole formulations, especially in European and certain developing markets, and maintains a network of regional manufacturing facilities.

5. Accord Healthcare

An important international generic drug manufacturer based in India, Accord Healthcare supplies albendazole under various brand names and in generic formats across multiple territories.

6. Mylan (now part of Viatris)

Mylan, which merged with Pfizer’s Upjohn unit to form Viatris, has historically supplied albendazole closely aligned with national procurement programs and WHO initiatives.

7. Local and Contract Manufacturers

In addition to these global players, numerous smaller, local, or contract manufacturing organizations (CMOs) produce albendazole for regional markets, often under licensing or partnership agreements. These include companies in China, Bangladesh, Egypt, and Latin America, providing flexible and cost-effective supply solutions for global health agencies.

Supply Chain Dynamics and Regulatory Considerations

The supply of Albenza hinges on several critical factors, including regulatory approvals, manufacturing capacity, and global health initiatives. The active pharmaceutical ingredient (API), albendazole, is synthesized through multi-step chemical processes involving key intermediates such as benzimidazole derivatives. Ensuring quality and stability in API production is essential to meet stringent pharmacopeial standards (e.g., USP, EP, JP).

Regulatory approvals from agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent bodies in emerging markets are prerequisites for market access. The regulatory landscape influences which manufacturers are authorized to supply specific regions, creating a complex web of approvals and compliance requirements.

Influencing Factors on Supply Stability

• Patent Status: Albendazole’s original patent has expired in most jurisdictions, facilitating generic production but potentially leading to market saturation and price competition.
• Manufacturing Capacity: Incidents such as raw material shortages, production halts due to quality issues, or regulatory sanctions can disrupt supply chains.
• Global Health Programs: WHO and UN agencies' procurement policies heavily influence supply, often prioritizing reliable, cost-effective generic manufacturers.
• Geopolitical Factors: Trade restrictions, import/export bans, and regional conflicts can impact supplier presence and distribution channels.
• Quality Assurance: Ongoing adherence to Good Manufacturing Practices (GMP) is vital for maintaining product integrity and avoiding supply disruptions due to compliance failures.

Emerging Trends and Future Outlook

The global demand for albendazole remains stable, driven by endemic parasitic diseases present in tropical and subtropical regions. To meet this demand, manufacturers are investing in expanding capacity and improving supply chain resilience. The increasing reliance on Indian and Chinese suppliers underscores the importance of economies of scale and cost efficiencies. Additionally, efforts toward developing alternative formulations, such as suspensions or pediatric-friendly dosage forms, continue to expand the supply ecosystem.

Furthermore, partnerships between multinational pharmaceutical companies and regional firms aim to enhance manufacturing capacity. The rise of Contract Manufacturing Organizations (CMOs) offers flexibility, allowing rapid scaling in response to global health crises. However, ensuring supply chain integrity and quality standards remains a priority for stakeholders.

Conclusion

The supply landscape for Albenza (albendazole) is characterized by a mix of multinational generic manufacturers, regional players, and CMOs. Key suppliers such as Teva, Zydus Cadila, Sanofi, Accord Healthcare, and Viatris play pivotal roles, with regional manufacturers in Asia, Africa, and Latin America complementing global efforts. Stability in supply hinges on manufacturing capacity, regulatory alignment, and the strategic prioritization of quality assurance. As global health needs evolve, maintaining a diversified and resilient supply chain will be crucial for ensuring consistent access to this essential anthelmintic.

Key Takeaways

• Major global suppliers include Teva, Zydus Cadila, Sanofi, Accord Healthcare, and Viatris (formerly Mylan).
• Regional and contract manufacturers supplement supply, especially for emerging markets.
• Patent expiry has facilitated broader generic manufacturing, increasing supply options but intensifying competition.
• Supply stability depends on capacity, regulatory compliance, and geopolitical factors.
• Ongoing investments in manufacturing expansion and quality assurance are vital to meet global demand.

FAQs

Q1: What factors influence the quality of albendazole supplied by different manufacturers?
Quality is governed by adherence to Good Manufacturing Practices (GMP), consistency in API synthesis, and compliance with pharmacopeial standards such as USP or EP. Regulatory approvals and audits play a crucial role in verifying quality standards.

Q2: Are there regional differences in suppliers for albendazole?
Yes. While global players like Teva and Viatris supply many markets, local or regional manufacturers in India, China, and Africa dominate supply in specific territories, influenced by regional regulatory approvals and cost considerations.

Q3: How do supply disruptions affect the availability of Albenza worldwide?
Disruptions, caused by manufacturing issues, raw material shortages, or regulatory challenges, can lead to temporary shortages. Such events can impact treatment access, especially in low-resource settings reliant on a limited number of suppliers.

Q4: What are the trends shaping future albendazole supply?
Key trends include increased capacity in India and China, diversification of suppliers, development of alternative formulations, and enhanced supply chain resilience through partnerships and CMOs.

Q5: How do regulatory agencies impact albendazole supplier operations?
Regulatory agencies enforce GMP standards, approve manufacturing sites, and ensure API compliance. Their directives determine market approval, influence manufacturing processes, and can lead to supply constraints if compliance issues arise.

References

1. U.S. Food and Drug Administration (FDA). Albendazole drug approval information. FDA.gov. 2022.
2. WHO Model List of Essential Medicines. Albendazole. WHO.int. 2022.
3. MarketWatch. Global pharmaceutical market analysis. 2023.
4. European Medicines Agency (EMA). Regulatory status of albendazole. EMA.europa.eu. 2022.
5. Indian Pharmaceutical Industry Reports. Zydus Cadila manufacturing capabilities. 2022.