EXTENDED PHENYTOIN SODIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	Amneal Pharmaceuticals LLC	65162-212-03	30 CAPSULE in 1 BOTTLE (65162-212-03)	2009-12-16
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	Amneal Pharmaceuticals LLC	65162-212-10	100 CAPSULE in 1 BOTTLE (65162-212-10)	2009-12-16
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	Amneal Pharmaceuticals LLC	65162-212-11	1000 CAPSULE in 1 BOTTLE (65162-212-11)	2009-12-16
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	Amneal Pharmaceuticals LLC	65162-212-50	500 CAPSULE in 1 BOTTLE (65162-212-50)	2009-12-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Extended phenytoin sodium, a critical anticonvulsant used to control generalized and focal seizure activity, is widely manufactured by numerous pharmaceutical suppliers globally. Its sustained-release formulation offers improved pharmacokinetic stability, enabling consistent blood plasma levels, which enhances therapeutic efficacy and compliance. This article examines key suppliers, their manufacturing capabilities, regulatory status, and market positioning, equipping business professionals with the insights necessary for strategic decision-making.

Overview of Extended Phenytoin Sodium

Extended phenytoin sodium formulations deliver the active ingredient over an extended timeframe, reducing dosing frequency and minimizing plasma concentration fluctuations common with traditional formulations. Given the drug's narrow therapeutic index, the quality, purity, and regulatory approval status of suppliers are critical factors influencing procurement.

Major Manufacturers and Suppliers

1. Pfizer Inc.

Pfizer remains a dominant player in the anticonvulsant market, offering extended phenytoin sodium under its well-recognized brand, Dilantin Kapseals. The company’s extensive manufacturing facilities adhere to rigorous FDA, EMA, and other global regulatory standards, ensuring consistent product quality. Pfizer’s market reach spans North America, Europe, and Asia, making it a preferred supplier for large healthcare providers.

Regulatory Highlights: FDA-approved manufacturing facilities; WHO GMP certification; stringent quality control protocols.

Market Presence: Strong global distribution network; longstanding market presence.

2. Teva Pharmaceutical Industries Ltd.

Teva is one of the largest generic drug manufacturers worldwide, providing high-quality extended phenytoin sodium formulations. Their generic version offers an affordable alternative to branded options without compromising on quality. Teva's robust supply chain and compliance with international regulatory standards make it a reliable supplier.

Regulatory Highlights: FDA ANDA approvals; EMA approvals; GMP-certified manufacturing plants.

Market Position: Significant presence in North America, Europe, and emerging markets.

3. Mylan (now part of Viatris)

Viatris, formed by the merger of Mylan and Pfizer’s Upjohn unit, supplies extended phenytoin sodium through its extensive generics portfolio. Their manufacturing facilities are compliant with global standards, and they focus on cost-effective production to meet increasing demand, especially in underserved markets.

Regulatory Highlights: Global approvals, including FDA, EMA, and other national authorities.

Supply Capabilities: Large-scale manufacturing capacity, emphasis on quality assurance.

4. Sandoz (Novartis)

Sandoz, as Novartis’ generics arm, offers extended phenytoin sodium renowned for high quality and affordability. Their products undergo rigorous testing, with a focus on bioequivalence and patient safety.

Regulatory Highlights: Stringent global regulatory approvals; adherence to GMP; ISO-certified facilities.

Market Reach: Focus on North America and Europe, expanding into emerging markets.

5. Strides Pharma Science Ltd.

An emerging player based in India, Strides manufactures extended phenytoin sodium for local and international markets. Their adherence to WHO GMP standards supports their inclusion in global supply chains seeking cost-effective solutions.

Regulatory Highlights: WHO PQ (Prequalification) status; US FDA approval for certain formulations.

Market Focus: Increased penetration in Asia, Africa, and other regions with high demand for affordable anticonvulsants.

Key Considerations When Choosing Suppliers

Regulatory Compliance: Suppliers should possess current approvals from relevant authorities such as the FDA, EMA, or WHO PQ, ensuring adherence to quality standards and facilitating market approval.
Manufacturing Capacity & Stability: Adequate capacity to meet demand fluctuations and supply chain resilience are key.
Product Quality & Bioequivalence: Confirmed by dossiers demonstrating consistency, stability, and bioequivalence to innovator products.
Pricing & Market Accessibility: Competitive pricing, especially for generics, impacts profitability and patient access.
Geographical Reach: Suppliers with broad distribution support international and regional market demands.
Documentation & Traceability: Comprehensive batch documentation, stability data, and traceability facilitate regulatory submissions.

Regulatory Landscape

The global market for extended phenytoin sodium is heavily regulated. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), produce bioequivalent formulations, and possess valid registration in target markets. Variations in approval processes across regions necessitate careful supplier evaluation to ensure regulatory acceptance.

Market Dynamics and Trends

The demand for extended phenytoin sodium continues to grow, driven by epilepsy prevalence and the shift toward sustained-release formulations. Generic manufacturers, especially in Asia and Eastern Europe, are expanding production capacities. Additionally, increasing approvals for bioequivalent formulations are broadening supplier options, encouraging competitive pricing and improved access.

Furthermore, the emergence of biosimilar and alternative formulations introduces new competitive pressures, emphasizing the importance of supplier agility and regulatory vigilance.

Supply Chain Challenges and Opportunities

Challenges:

Regulatory delays can hinder market entry.
Raw material shortages impact manufacturing.
Quality assurance inconsistencies pose risks.

Opportunities:

Partnering with WHO PQ-certified suppliers improves global access.
Investing in supply chain diversification minimizes disruptions.
Leveraging emerging markets expands reach and reduces costs.

Conclusion

The procurement of extended phenytoin sodium involves navigating a competitive landscape populated by established multinational corporations and capable regional manufacturers. Major suppliers such as Pfizer, Teva, Viatris, Sandoz, and Strides provide reliable, regulatory-compliant options, with distinctions in pricing, manufacturing capacity, and market coverage. Business professionals must prioritize regulatory compliance, quality standards, and supply chain resilience to optimize procurement strategies.

Key Takeaways

Leading global suppliers of extended phenytoin sodium include Pfizer, Teva, Viatris (Mylan), Sandoz, and emerging regional manufacturers like Strides.
Ensuring regulatory compliance and product bioequivalence is essential for market acceptance and patient safety.
Supply chain resilience and capacity are critical amid increasing demand and global disruptions.
Cost considerations favor generic manufacturers, especially in emerging markets, expanding access.
Maintaining an up-to-date understanding of regulatory landscapes and market dynamics enhances procurement decision-making.

FAQs

1. What are the main qualities to consider when selecting a supplier for extended phenytoin sodium?
Regulatory approval, product quality and bioequivalence, manufacturing capacity, pricing, and supply chain stability.

2. Are generic formulations of extended phenytoin sodium as effective as brand-name versions?
Yes, when they meet regulatory standards and bioequivalence criteria, generics offer comparable efficacy and safety.

3. How do regulatory differences impact supplier selection?
Manufacturers with approvals from key agencies such as the FDA, EMA, or WHO PQ are more likely to have compliant products suitable for global markets.

4. What are current market trends influencing suppliers of extended phenytoin sodium?
Growing demand due to epilepsy prevalence, increasing approvals of bioequivalent formulations, and expansion of manufacturing capabilities in emerging markets.

5. How does supply chain resilience affect procurement decisions?
A resilient supply chain reduces risks of shortages and delays, ensuring consistent patient access and regulatory compliance.

References

U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
World Health Organization. (2021). Prequalification of Medicines Programme.
European Medicines Agency. (2022). Summary of Product Characteristics for Phenytoin Sodium Extended-Release Capsules.
MarketResearch.com. (2022). Global Anticonvulsant Drugs Market Analysis.
Pfizer Inc. Corporate Website. (2023). Product Portfolio.

Suppliers and packagers for EXTENDED PHENYTOIN SODIUM