Suppliers and packagers for ZARONTIN

ZARONTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Parke Davis	ZARONTIN	ethosuximide	CAPSULE;ORAL	012380	NDA	Parke-Davis Div of Pfizer Inc	0071-0237-24	100 CAPSULE in 1 BOTTLE (0071-0237-24)	2000-09-22
Parke-davis	ZARONTIN	ethosuximide	SYRUP;ORAL	080258	ANDA	Parke-Davis Div of Pfizer Inc	0071-2418-19	1 BOTTLE, PLASTIC in 1 CARTON (0071-2418-19) / 474 mL in 1 BOTTLE, PLASTIC	2020-03-10
Parke-davis	ZARONTIN	ethosuximide	SYRUP;ORAL	080258	ANDA	Mylan Pharmaceuticals Inc.	59762-2350-6	1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-6) / 474 mL in 1 BOTTLE, PLASTIC	2020-02-21
Parke-davis	ZARONTIN	ethosuximide	SYRUP;ORAL	080258	ANDA	Mylan Pharmaceuticals Inc.	59762-2350-7	1 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7) / 474 mL in 1 BOTTLE, PLASTIC	2020-02-21

Suppliers for the Pharmaceutical Drug: ZARONTIN

Last updated: August 5, 2025

Introduction

ZARONTIN, known by its generic name ethosuximide, is an anticonvulsant primarily prescribed for the management of absence seizures, a form of epilepsy. Recognized for its efficacy and long-standing clinical use, ZARONTIN has established a substantial presence within the pharmaceutical market. The manufacturing and distribution of ethosuximide involve a range of suppliers, including branded drug developers, generic pharmaceutical companies, contract manufacturing organizations (CMOs), and distributors dedicated to ensuring global accessibility.

This analysis offers a comprehensive overview of key suppliers involved in ZARONTIN’s production, considering the current landscape marked by patent expirations, generic proliferation, and evolving regulatory frameworks. It aims to provide business professionals with actionable insights into supply chain dynamics, potential market players, and strategic considerations for stakeholders involved in procurement, manufacturing, or distribution.

Manufacturers of ZARONTIN (Ethosuximide): Market Dynamics

Branded vs. Generic Suppliers

Since ZARONTIN’s patent expiration, the market has seen a significant shift toward generic production. The original patent holder, GlaxoSmithKline, introduced ethosuximide under the ZARONTIN brand, but patent protections have long since expired, opening the sector to multiple generic manufacturers.

Branded Suppliers:
Currently, GSK (GlaxoSmithKline) remains the most identifiable brand, although its market share has diminished with the advent of generics. Branded ethosuximide offers the assurance of consistent quality and regulatory compliance, appealing to certain markets, especially in regions with stringent procurement standards.

Generic Suppliers:
The majority of ethosuximide supply now originates from generic pharmaceutical companies. These include both large multinational firms and regional players with robust manufacturing capabilities. The competitive landscape is characterized by price sensitivity, regulatory compliance, and manufacturing capacity.

Major Global Suppliers and Regions

United States and Europe

In developed markets such as the United States and Europe, the supply of ethosuximide primarily stems from prominent pharmaceutical companies with established manufacturing facilities that adhere to Good Manufacturing Practices (GMP). Companies such as:

• Teva Pharmaceuticals: A leading generic manufacturer globally, Teva supplies ethosuximide through its extensive generic portfolio.
• Sandoz (Novartis): Has a history of producing ethosuximide, particularly in European markets, under its comprehensive generic offerings.
• Mylan (now part of Viatris): Offers ethosuximide as part of its anticonvulsant range, focusing on cost-effective generics.
• Cipla and Sun Pharmaceutical Industries: Among other Indian pharmaceutical giants, they produce ethosuximide for international markets, leveraging India’s robust generic manufacturing sector.

Emerging and Developing Markets

In regions such as Latin America, Southeast Asia, and Africa, local generic manufacturers and regional distributors dominate the supply. These suppliers often acquire licenses or produce ethosuximide under local regulatory approvals.

Contract Manufacturing Organizations (CMOs)

Several CMOs offer ethosuximide manufacturing capabilities to brand-name and generic companies. Notable CMOs such as JRS Pharma, Lonza, and Catalent provide formulation development, sterile manufacturing, and packaging services, facilitating supply chain agility and compliance.

Supply Chain Considerations

Regulatory Compliance and Quality Standards

Suppliers must comply with regional regulatory standards such as the U.S. FDA, European EMA, and WHO GMP guidelines. Regulatory approvals influence supplier eligibility, especially for exports and procurement in regulated markets.

Manufacturing Capacity & Scalability

The global demand for ethosuximide is relatively stable but sensitive to regional epilepsy prevalence and treatment guidelines. Suppliers with scalable manufacturing infrastructure and robust supply chains are positioned to meet sustained demand, especially in emerging markets.

Supply Chain Risks & Disruptions

The COVID-19 pandemic underscored vulnerabilities across the pharmaceutical supply chain, including shortages stemming from manufacturing delays, raw material shortages, and regulatory backlogs. Suppliers with diversified manufacturing sites and reliable logistics networks mitigate such risks.

Key Players in Ethosuximide Supply

Supplier	Market Focus	Region	Notes
Teva Pharmaceuticals	Global	North America, Europe, Asia	Major generic producer with GMP-compliant manufacturing.
Sandoz (Viatris)	Global	Europe, North America	Extensive portfolio in anticonvulsants.
Mylan (Viatris)	Global	Worldwide	Cost-competitive ethosuximide supply.
Cipla	Emerging Markets	India, Africa, Southeast Asia	Regionally strong with affordable options.
Sun Pharmaceutical Industries	Emerging Markets	India, Middle East	Significant local production capacity.
JRS Pharma, Lonza, Catalent (CMOs)	Contract Manufacturing	Global	Supports OEM manufacturing and formulation development.

Market Trends and Future Outlook

The ethosuximide market remains largely stable, driven by longstanding clinical efficacy and a lack of direct substitutes for certain epilepsy subtypes. The increasing emphasis on cost-effective generics bolsters the role of Indian and Asian manufacturers. Emerging markets, due to their increasing healthcare investment, are likely to see expanded supplier engagement.

Regulatory harmonization and quality assurance continue to shape supplier selection, with non-compliance risking market access. Supply chain resilience strategies, such as dual sourcing across regions, are increasingly pivotal.

Conclusion

The supply landscape for ZARONTIN (ethosuximide) hinges on a broad spectrum of global and regional manufacturers, with prominent roles played by generic pharmaceutical companies and contract manufacturers. The market's evolution post-patent expiration emphasizes cost competition, regulatory compliance, and supply chain resilience. For stakeholders, understanding these dynamics is essential for procurement strategies, risk management, and negotiating favorable contracts.

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Key Takeaways

• Ethosuximide's global supply is dominated by generic manufacturers, with Teva, Sandoz, and Mylan leading in capacity and market reach.
• Regionalized supply from Indian companies like Cipla and Sun Pharma caters effectively to emerging markets.
• Contract manufacturing organizations play a critical role in scalable, compliant production, especially for OEMs.
• Supply chain risks, including geopolitical, logistical, and regulatory factors, necessitate diversification of sources.
• Continuous regulatory oversight and quality compliance are vital for market access and product safety.

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FAQs

Q1: Who are the primary global suppliers of ethosuximide?
A1: The leading global suppliers include Teva Pharmaceuticals, Sandoz (Viatris), and Mylan (Viatris), with numerous regional producers, especially in India, contributing to the market.

Q2: Is ZARONTIN available as a generic worldwide?
A2: Yes, after patent expiration, ethosuximide is widely available as a generic in most markets, with the exception of specific regions where regulatory or patent protections are still in place.

Q3: What are the main considerations when sourcing ethosuximide from suppliers?
A3: Key considerations include regulatory compliance (GMP certification), manufacturing capacity, quality assurance, logistical reliability, and cost competitiveness.

Q4: How do supply chain disruptions affect ethosuximide availability?
A4: Disruptions can lead to shortages, impacting treatment continuity. Diversifying supply sources and maintaining inventory buffers are strategies to mitigate such risks.

Q5: What future trends could influence ethosuximide suppliers?
A5: Trends include increased regional manufacturing in emerging markets, regulatory harmonization, and advancements in supply chain technology to enhance resilience and traceability.

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References:

1. [1] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. [2] GlobalData Pharma Intelligence. (2022). Market Analysis & Forecast for Anticonvulsants.
3. [3] IQVIA. (2022). The Global Use of Medicines in Epilepsy.
4. [4] DrugMaster. (2021). Global Contract Manufacturing in Pharmaceuticals.
5. [5] World Health Organization. (2021). Model List of Essential Medicines.