Suppliers and packagers for phenytek

phenytek

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-2670-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)	2001-12-10
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-2670-93	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-93)	2001-12-10
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-3750-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)	2001-12-10
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Mylan Pharmaceuticals Inc.	0378-3750-93	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)	2001-12-10
Mylan	PHENYTEK	phenytoin sodium	CAPSULE;ORAL	040298	ANDA	Coupler LLC	67046-1486-3	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)	2025-01-29

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Phenytek

Introduction
Phenytek, the brand name for phenytoin sodium capsules, is a widely utilized antiepileptic medication indicated for the management of various seizure disorders. As a critical pharmaceutical product, its supply chain encompasses multiple manufacturers, distributors, and importers globally. Ensuring consistent availability of Phenytek hinges on reliable supplier relationships, regulatory compliance, and market dynamics. This analysis explores the primary suppliers, manufacturing landscape, and market considerations supporting Phenytek’s global distribution.

Overview of Phenytek’s Market and Regulatory Context
Phenytek (phenytoin sodium) is approved by the U.S. Food and Drug Administration (FDA) and comparable authorities worldwide for long-term control of generalized and partial seizures. The drug’s manufacturing is governed by strict Good Manufacturing Practices (GMP), ensuring product quality and safety. Due to its medical importance, various pharmaceutical firms and contract manufacturing organizations (CMOs) produce and supply phenytoin formulations, including Phenytek.

Key Manufacturers and Suppliers of Phenytek

1. Pfizer Inc.
Pfizer is a prominent supplier of Phenytek in the United States. As the originator of the brand, Pfizer maintains a robust manufacturing infrastructure for Phenytek capsules, ensuring FDA compliance to meet US market demand. Pfizer’s global presence and extensive distribution channels make it a primary supplier for healthcare providers and pharmacies in North America.

2. Mylan/Novartis (Now part of Viatris Inc.)
Historically, Mylan (acquired by Viatris) has been a significant producer of generic phenytoin sodium products, including sustained-release and injectable formulations. Their large-scale manufacturing capacity and regional distribution networks make them a core supplier for markets outside the US or for generic versions of Phenytek.

3. Teva Pharmaceutical Industries Ltd.
Teva, one of the world’s leading generic drug manufacturers, produces phenytoin sodium capsules and injectable products. Their global reach and extensive portfolio of antiepileptic drugs position them as a key supplier, especially in European and emerging markets. Teva’s reputation for high-quality generics ensures a steady supply chain for phenytoin.

4. Sun Pharmaceutical Industries Ltd.
Sun Pharma manufactures and distributes generic phenytoin formulations, serving markets in India, Southeast Asia, and other regions. Their manufacturing facilities are GMP-compliant, and the company’s focus on cost-effective production helps ensure broad accessibility.

5. Other Regional and Contract Manufacturers
In addition to the above, several regional suppliers and Contract Manufacturing Organizations (CMOs) produce phenytoin sodium compounds for various markets. Companies like PMP Pharmaceuticals, Amneal Pharmaceuticals, and others may hold regional manufacturing rights or supply agreements to meet specific market needs.

Market Dynamics Influencing Supply

a. Regulatory Approvals and Quality Standards
Manufacturers must adhere to stringent regulatory standards, including the FDA in the U.S., EMA in Europe, and foreign agencies where they export. Changes in regulatory requirements, such as grey market or import/export restrictions, directly influence supplier availability and supply chains.

b. Manufacturing Capacity and Raw Material Supply
Phenytoin’s active pharmaceutical ingredient (API) sourcing impacts supply reliability. Fluctuations in API manufacturing, often concentrated in specific regions (e.g., China and India), can cause shortages or delays. Additionally, manufacturing capacity constraints during global disruptions, such as pandemics, can affect supply continuity.

c. Patent and Market Exclusivity Status
Phenytek’s patent status influences the entry of generic suppliers. Once patents expire, multiple generics, supplied by various manufacturers, typically enter the market, increasing competition and supply robustness. Currently, patent protections for Phenytek have largely expired or are nearing expiration, enabling a broader supplier base.

d. Distribution and Supply Chain Risks
Disruptions—such as transportation issues, geopolitical tensions, or regulatory barriers—potentially impair the secure supply of Phenytek across regions. Ensuring diversified supplier bases and regional manufacturing can mitigate these risks.

Global Distribution and Key Market Considerations

United States:
Pfizer remains the primary supplier, with generic rivals providing alternatives. The U.S. market’s extensive regulatory oversight demands high compliance, often resulting in limited supplier diversification.

Europe:
Teva and other generics dominate European markets, with multiple regional GMP-certified manufacturing facilities ensuring supply stability.

Emerging Markets:
Sun Pharma and local generics manufacturers serve as significant sources, often with lower logistical barriers but variable quality standards, underscoring the importance of regulatory oversight.

Impacts of Supply Chain Challenges and Regulatory Changes

The production of phenytoin faces ongoing challenges, including API shortages, patent litigation, and evolving regulatory landscapes. These factors can cause intermittent shortages, forcing clinicians and healthcare systems to seek alternative formulations or drugs. Suppliers responding adeptly to these challenges maintain their market position and ensure ongoing supply.

Conclusion
A robust supply chain for Phenytek relies on a diversified cohort of manufacturers, including Pfizer, Mylan/Viatris, Teva, Sun Pharma, and regional players. Navigating regulatory environments, ensuring API supply, and adapting to market demands are critical for maintaining steady product availability. Healthcare providers and procurement entities should monitor these supplier dynamics and geopolitical factors to safeguard uninterrupted access to this essential anticonvulsant.

Key Takeaways

• Multiple manufacturers globally supply Phenytek, ensuring redundancy and supply stability.
• Pfizer remains the primary supplier in the U.S., while Teva, Viatris, and Sun Pharma predominate internationally.
• API sourcing and manufacturing capacity are critical to overcoming supply disruptions.
• Regulatory compliance and market exclusivity influence supplier participation and product availability.
• Diversification of suppliers and regional manufacturing capacity mitigate risks from geopolitical and logistical disruptions.

FAQs

1. Who are the main global suppliers of Phenytek?
Pfizer (U.S.), Teva, Viatris (formerly Mylan), and Sun Pharma are leading global suppliers, supplying both brand and generic phenytoin formulations across different markets.

2. Are there regional differences in Phenytek suppliers?
Yes. Pfizer primarily supplies the U.S., while Teva and Viatris dominate European and other international markets. Regional generic manufacturers supply emerging markets, often with varying quality standards.

3. How does API availability affect Phenytek supply?
API shortages, especially from sources in China and India, can lead to manufacturing delays and drug shortages, underscoring the importance of diversified API supply chains.

4. What regulatory factors influence supplier reliability?
Compliance with regulatory standards such as FDA, EMA, and local agencies ensures consistent manufacturing quality, impacting supplier credibility and market access.

5. What are future prospects for Phenytek supply stability?
With the expiration of key patents and increased generic competition, supply stability is expected to improve. However, ongoing geopolitical and supply chain disruptions warrant continuous risk mitigation strategies.

Sources
[1] U.S. Food and Drug Administration (FDA) – Approved drug products.
[2] Pfizer corporate disclosures and product portfolio.
[3] Teva Pharmaceutical Industries Ltd. official website.
[4] Viatris Inc. product catalog.
[5] Sun Pharmaceutical Industries Ltd. global manufacturing footprint.