Suppliers and packagers for zonegran

zonegran

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Advanz Pharma (US) Corp.	59212-680-10	100 CAPSULE in 1 BOTTLE (59212-680-10)	2000-03-27
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Advanz Pharma (US) Corp.	59212-681-10	100 CAPSULE in 1 BOTTLE (59212-681-10)	2000-03-27

Suppliers for the Pharmaceutical Drug: Zonegran

Last updated: July 30, 2025

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Introduction

Zonegran, the brand name for zonisamide, is an anticonvulsant medication primarily prescribed for the management of epilepsy and certain types of seizures. Developed by Eisai Co., Ltd., Zonegran has gained significant market traction, driven by its efficacy and unique pharmacological profile. As with many branded pharmaceuticals, the supply chain for Zonegren involves a complex network of manufacturers, authorized distributors, and generic manufacturers. This article examines the key suppliers, their roles, and the broader implications for stakeholders seeking reliable procurement channels.

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Manufacturers of Zonegran

Eisai Co., Ltd.

Eisai is the original developer and patent holder for Zonegran. The Japanese pharmaceutical giant manufactures the drug in adherence to strict Good Manufacturing Practices (GMP) guidelines, ensuring high-quality production standards. Eisai’s manufacturing plants are certified by regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). As the patent holder, Eisai retains significant control over the supply, pricing, and distribution of Zonegran in markets where patent protection is valid.

Authorized Generics and Licensing Agreements

Once patent protections expire, generic manufacturers often emerge. In some regions, Eisai licenses or partners with generic producers for local manufacturing. This approach ensures the continued supply of zonisamide across different markets, often at reduced prices. These authorized generics are manufactured under strict quality controls comparable to the original product, maintaining efficacy and safety.

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Generic Suppliers and Market Dynamics

Generic Manufacturers

As of 2023, multiple pharmaceutical companies produce generic versions of Zonegran. These typically include:

• Teva Pharmaceuticals: A global leader in generics, Teva produces zonisamide that conforms to regulatory standards, offering a cost-effective alternative.
• Mylan (now part of Viatris): Mylan emerged as a significant supplier post-patent expiration, meeting regional demand where high manufacturing standards are maintained.
• Sandoz (Novartis division): Provides biosimilar and generic versions in various markets.
• Hetero Labs, Dr. Reddy’s Laboratories, and other regional players: These companies manufacture zonisamide for the local markets, often in countries like India, China, and Brazil.

Market considerations such as bioequivalence, regulatory approval status, and local availability govern the selection of generic suppliers. While generics are typically bioequivalent, variability in manufacturing processes necessitates robust quality assurance to prevent batch-to-batch inconsistencies.

Regional Market Penetration

The penetration of generic suppliers varies across jurisdictions:

• United States: Multiple FDA-approved generic manufacturers supply zonisamide, ensuring competitive pricing.
• European Union: NMEs (New Molecular Entities) like Zonegran are available via generic equivalents from numerous suppliers, subject to EMA approval.
• Emerging Markets: Indian and Chinese pharmaceutical companies have become predominant suppliers, catering to local and regional needs.

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Distribution Channels and Supply Chain Considerations

Authorized Distributors

Authorized distributors play a pivotal role in ensuring the safe and compliant distribution of Zonegran from manufacturers to healthcare providers and pharmacies. These are typically vetted by manufacturers or regulatory authorities, ensuring storage, transportation, and handling meet quality standards.

Importers and Contract Manufacturing

In countries where direct manufacturing is absent, importers facilitate supply chains. Some pharmaceutical firms outsource manufacturing via contract manufacturing organizations (CMOs), especially for regional or generic variants. These CMOs adhere to international GMP standards, providing scalable production capacity.

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Regulatory Compliance and Quality Assurance

Suppliers across all categories must comply with strict regulatory standards concerning:

• Manufacturing Quality (GMP compliance)
• Product Authentication and Traceability
• Stability and Shelf-life Testing
• Proper Labeling and Packaging

Regulatory agencies such as the FDA, EMA, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan enforce these standards. Unauthorized or counterfeit supplies pose risks to patient safety and supply integrity.

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Market Challenges and Opportunities

Supply Chain Disruptions

Global disruptions, including those caused by the COVID-19 pandemic, have highlighted vulnerabilities in pharmaceutical supply chains. Shortages of zonisamide can occur due to manufacturing delays, regulatory hurdles, or geopolitical issues.

Opportunities for Procurement

• Partnering with licensed and reputable suppliers ensures quality assurance.
• Monitoring regulatory updates for approvals and new market entrants can optimize procurement.
• Engaging with authorized distributors reduces counterfeiting risks and ensures compliance.

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Key Takeaways

• Original manufacturer Eisai maintains control over Zonegran production, with licensing and authorized generics extending supply options.
• A diverse array of generic suppliers, such as Teva, Mylan, and Sandoz, provide cost-effective alternatives following patent expiration.
• Ensuring regulatory compliance and quality assurance is critical for safe procurement; reliance on licensed suppliers minimizes risks.
• Regional market dynamics influence supplier choices, with emerging markets heavily reliant on local manufacturers.
• Supply chain resilience demands proactive monitoring of regulatory updates, manufacturing capacity, and geopolitical factors.

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FAQs

1. Who are the primary suppliers of Zonegran globally?
The original manufacturer is Eisai Co., Ltd. In addition, authorized generics and licensed distributors like Teva, Mylan (Viatris), and Sandoz supply zonisamide across various markets, especially post-patent expiry.

2. How can healthcare providers ensure the authenticity of Zonegran supplies?
Procure exclusively from licensed distributors and authorized pharmacies. Confirm packaging integrity, batch numbers, and regulatory approval markings. Avoid unverified online sources.

3. Are generic versions of Zonegran as effective as the brand-name product?
Regulatory agencies require generics to demonstrate bioequivalence to the brand-name drug, making them equally effective when manufactured under GMP standards.

4. What are the supply chain risks associated with Zonegran?
Risks include manufacturing delays, shortages due to regulatory or geopolitical issues, counterfeit products, and disruptions caused by global crises like pandemics.

5. How can procurement entities mitigate supply disruptions for Zonegran?
Diversify supplier base, establish relationships with multiple licensed distributors, monitor regulatory changes, and maintain safety stock levels to buffer short-term shortages.

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References

1. Eisai Co., Ltd. Official Website. Product information on Zonegran.
2. U.S. Food and Drug Administration (FDA). Approved generic drugs list.
3. European Medicines Agency (EMA). Market authorization for zonisamide.
4. International pharmaceutical market reports on generic drug supply chains.
5. World Health Organization (WHO). Guidelines for the quality assurance of medicines.