Suppliers and packagers for generic pharmaceutical drug: PHENYTOIN

PHENYTOIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	DILANTIN-125	phenytoin	SUSPENSION;ORAL	008762	NDA	Viatris Specialty LLC	58151-115-35	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC	2024-04-19
Viatris	DILANTIN-125	phenytoin	SUSPENSION;ORAL	008762	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0531-2	1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC	2020-04-22
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762	NDA	Viatris Specialty LLC	58151-115-35	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC	2024-04-19
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0531-2	1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC	2020-04-22

Suppliers for the Pharmaceutical Drug: Phenytoin

Last updated: July 28, 2025

Introduction

Phenytoin, a widely used antiepileptic drug, has been a cornerstone in managing seizure disorders since its approval in the late 1930s. Its efficacy in controlling various seizure types has established it as a critical medication globally. As market demands evolve and regulatory standards become more rigorous, understanding the landscape of suppliers providing phenytoin is essential for stakeholders, including pharmaceutical manufacturers, healthcare providers, and investors.

This article provides a comprehensive overview of the primary suppliers of phenytoin, exploring manufacturing sources, supply chain dynamics, regulatory considerations, and market trends. Emphasis is placed on identifying key players, assessing supply stability, and analyzing the implications of supplier diversification.

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Manufacturers of Phenytoin: Global Landscape

The production of phenytoin is distributed among several pharmaceutical companies worldwide, primarily in regions such as North America, Europe, India, and China. The manufacturing process involves complex synthesis and strict quality controls to meet regulatory standards set by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities.

Major Pharmaceutical Companies and Contract Manufacturers

1. Pfizer Inc.
   Pfizer was historically a significant producer of phenytoin-based products, including the brand Dilantin. Although Pfizer sold its legacy manufacturing assets in 2018, its original production facilities continue to operate under different ownership or licensing agreements, often supplying generic formulations.

2. Taj Pharmaceuticals Ltd.
   An Indian pharmaceutical company recognized for manufacturing generic phenytoin sodium formulations. Taj operates several manufacturing plants compliant with WHO-GMP standards, serving both domestic and export markets.

3. Sagent Pharmaceuticals (now part of Hikma Pharmaceuticals)
   Sagent, acquired by Hikma, supplies phenytoin injections and oral formulations, emphasizing sterile manufacturing capabilities and quality compliance.

4. Wockhardt Ltd.
   India-based Wockhardt produces various anticonvulsants, including phenytoin, with a robust export footprint, adhering to international regulatory standards.

5. Sun Pharmaceutical Industries Ltd.
   As one of India's largest pharmaceutical firms, Sun Pharma manufactures and distributes phenytoin products globally. Its extensive manufacturing capacity supports stable supply for multiple markets.

6. Mylan / Viatris
   Before its merger with Pfizer's legacy assets, Mylan was a significant supplier of generic phenytoin. Post-merger, Viatris continues to supply these products, emphasizing its global manufacturing footprint.

7. Contract Manufacturing Organizations (CMOs)
   Numerous CMOs globally produce phenytoin under licensing agreements for multiple brands. Companies like Lek Pharmaceuticals (part of Sandoz) and other regional CMOs provide essential manufacturing capacity, often for generic formulations.

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Supply Chain Dynamics and Market Trends

The supply landscape of phenytoin is characterized by high dependence on manufacturing hubs in India and China. These regions account for a substantial share of global generic production due to cost efficiencies and established quality standards.

Key Supply Chain Challenges:

• Regulatory Variability: Compliance with Good Manufacturing Practices (GMP) varies across countries, affecting product quality and market access.
• Raw Material Sourcing: The synthesis of phenytoin involves specific intermediates sourced from multiple suppliers, impacting production continuity.
• Manufacturing Consolidation: Mergers and acquisitions, such as Hikma's acquisition of Sagent or Viatris's consolidation, influence supplier diversity and market stability.
• Patent and Regulatory Barriers: While phenytoin is generally off-patent, regional patent laws and regulatory approvals can impact the entry of new suppliers.

Market Trends:

• Increased demand for generic phenytoin, driven by healthcare cost pressures and expanding indications, has incentivized manufacturers to scale production.
• The ongoing globalization of pharmaceutical manufacturing has diversified supply sources but also heightened vulnerability to geopolitical and trade disruptions.
• The COVID-19 pandemic exposed vulnerabilities in supply chains, prompting strategic assessments to enhance resiliency.

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Regulatory Considerations for Suppliers

Suppliers must navigate complex regulatory environments to maintain market access. Regulatory agencies scrutinize manufacturing processes, potency, stability, and sterility. Suppliers with compliant facilities, particularly in regions like the US (FDA-approved facilities), Europe (EMA-approved), and WHO-GMP certified plants in India and China, are preferred.

Certification standards are often prerequisite for supplying hospitals and wholesalers in developed markets. Additionally, adherence to pharmacovigilance requirements ensures ongoing license validity.

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Market Implications and Supplier Diversification

Given the high stakes associated with seizure management, ensuring a resilient, diversified supply chain is critical. Reliance on a limited number of suppliers introduces risks of shortages, which can have severe clinical and commercial repercussions. To mitigate such risks, pharmaceutical companies and healthcare providers are increasingly seeking multiple sources and regional diversification.

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Conclusion

The supply of phenytoin hinges on a network of global manufacturers, with prominent players spanning North America, Europe, India, and China. While multinational pharmaceutical companies, including Wockhardt, Sun Pharma, and Hikma, play significant roles, a considerable portion of production is handled by regional CMOs and generic manufacturers.

Market dynamics underscore the importance of supply chain resilience—through diversification, adherence to regulatory standards, and strategic planning—to address challenges such as raw material sourcing, regulatory compliance, and geopolitical risks.

Stakeholders must continuously monitor supplier reliability, regulatory status, and capacity to ensure sustained access to this vital antiepileptic drug.

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Key Takeaways

• Diverse Supplier Base: The global phenytoin supply landscape features key players in India, China, Europe, and North America, with India and China being dominant manufacturing hubs.
• Quality and Regulatory Standards: Suppliers with WHO-GMP, FDA, or EMA certifications are preferred for their assured compliance and market access.
• Supply Chain Risks: Geopolitical tensions, raw material availability, and regulatory changes pose ongoing risks, emphasizing the need for supplier diversification.
• Market Trends: Growing demand for generics and the influence of market consolidation necessitate vigilant supplier management.
• Strategic Resilience: Companies should prioritize building resilient supply chains with multiple suppliers and regional manufacturing to mitigate shortages.

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FAQs

1. Who are the leading manufacturers of phenytoin globally?
   Leading manufacturers include Wockhardt, Sun Pharma, Hikma (via Sagent), Taj Pharmaceuticals, and contract manufacturers supplying generic formulations worldwide.

2. Is phenytoin supply at risk due to manufacturing concentration in specific regions?
   Yes. Heavy reliance on Indian and Chinese manufacturing increases vulnerability to regional disruptions, prompting calls for diversification.

3. What regulatory standards must suppliers meet to export phenytoin internationally?
   They must comply with GMP standards recognized by agencies such as the FDA, EMA, and WHO, ensuring product safety, potency, and quality.

4. How has market demand impacted phenytoin manufacturing?
   Rising demand for affordable generics and expanded epilepsy treatment options have led to increased production and capacity expansion among major suppliers.

5. Are there alternative suppliers besides traditional pharmaceutical companies?
   Yes. Numerous CMOs and regional manufacturers produce phenytoin under licensing agreements, helping diversify the supply chain.

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References

1. [1] U.S. Food and Drug Administration (FDA). Pharmaceutical Quality Notification, 2022.
2. [2] European Medicines Agency (EMA). Manufacturing Standards for Antiepileptic Drugs, 2022.
3. [3] Global Data, Market Analysis Reports on Pharmacological Production, 2022.
4. [4] Indian Pharmaceutical Alliance. Annual Report on Generic Drug Manufacturing, 2022.
5. [5] Supply Chain Resilience in Pharmaceuticals. International Council of Pharmaceuticals, 2021.