Suppliers and packagers for mysoline

mysoline

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant	MYSOLINE	primidone	TABLET;ORAL	009170	NDA	Bausch Health US, LLC	66490-690-10	100 TABLET in 1 BOTTLE (66490-690-10)	2009-06-24
Valeant	MYSOLINE	primidone	TABLET;ORAL	009170	NDA	Bausch Health US, LLC	66490-691-10	100 TABLET in 1 BOTTLE (66490-691-10)	2009-06-24

Suppliers for the Pharmaceutical Drug: MYSOLINE

Last updated: July 29, 2025

Introduction

MYSOLINE, known generically as primidone, is an antiepileptic medication primarily prescribed to manage seizure disorders, including generalized seizures and certain types of epilepsy. As a critical therapeutic agent, the security of its supply chain is vital for healthcare providers, especially considering the prevalence of epilepsy and seizure-related conditions worldwide. Identifying and analyzing key suppliers for MYSOLINE provides insights into market dynamics, manufacturing capacity, and risk management strategies essential for stakeholders such as pharmaceutical companies, healthcare providers, and regulatory agencies.

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Manufacturers of MYSOLINE (Primidone)

Primidone was originally developed in the mid-20th century and has since been produced by multiple pharmaceutical manufacturers. Notably:

• Meda (now part of Mylan)
  Historically, Meda Pharmaceuticals was a prominent supplier of MYSOLINE. In 2016, Mylan acquired Meda, expanding its portfolio of generic medications, including primidone. Mylan remains a key supplier in various markets, especially in North America and Europe, where generic versions of primidone are approved and supplied.

• Genus Pharmaceuticals (a division of Apotex)
  Genus Pharmaceuticals manufactures generic primidone marketed under various brand or generic labels, primarily serving the European and Canadian markets.

• Sanofi
  Although Sanofi is a significant player in several CNS drugs, it has phased out or limited primidone production, focusing instead on other epilepsy medications.

• Other Generics Manufacturers
  Numerous regional or local generic drug producers manufacture primidone, often under different brand names or as unbranded generics. These include companies in India, China, and Eastern Europe, which serve markets with less regulatory barriers and lower production costs.

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Market Dynamics and Supply Chain Considerations

The supply chain for MYSOLINE has historically been characterized by supply constraints due to factors such as limited manufacturing incentives, low profit margins, and regulatory hurdles associated with generics production. As a legacy drug, primidone's market presence is more prominent in countries with established generic markets like the US, Europe, and Canada.

Manufacturing Challenges & Regulatory Oversight:
Manufacturers must comply with Good Manufacturing Practices (GMP) mandated by agencies such as the U.S. FDA, EMA, and Health Canada. Disruptions, such as manufacturing plant inspections, quality issues, or raw material shortages, can significantly impact supply stability. For instance, in recent years, active pharmaceutical ingredient (API) shortages have affected various antiepileptic drugs, including primidone, partly due to global supply chain disruptions.

Supply Concentration Risks:
While multiple manufacturers produce primidone, a significant portion of the supply in certain regions is concentrated among a few large players like Mylan (Meda), which raises concerns over supply resilience. Dependence on a limited number of API suppliers or manufacturing sites could render the supply chain vulnerable to disruptions.

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Key Suppliers and Distributors in Major Markets

Supplier / Manufacturer	Region / Market Focus	Production Notes	Regulatory Status
Mylan (formerly Meda)	North America, Europe	Major supplier of generic primidone	FDA, EMA approved
Apotex / Genus	Canada, Europe, emerging markets	Active in generic primidone production	Health Canada, EMA registered
IndoPharma, Hetero Drugs	India, Asia	Produce cost-effective generics, including primidone	DCGI (India), adherence to ISO and local GMP standards
Other regional manufacturers	Latin America, Africa	Smaller scale operations, varying quality controls	Local regulatory approval, international GMP standards

Distribution Networks:
Distribution channels for primidone include wholesale pharmacy suppliers, hospital formularies, pharmacy chains, and online pharmacies. Distribution networks worldwide must maintain strict temperature and storage conditions to ensure drug efficacy and safety.

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Emerging Trends and Impact on Suppliers

Generics Market Evolution:
The increasing demand for affordable epilepsy medications sustains a steady market for primidone, particularly in low- to middle-income countries. However, newer antiepileptic drugs (AEDs) with better tolerability profiles are gradually replacing primidone in some markets, impacting demand dynamics.

Manufacturing Consolidation:
Major players consolidating their portfolios may deprioritize primidone production, leading to reduced supply options. Conversely, newer entrants focusing on cost-effective manufacturing in emerging markets are expanding supply options and disrupting traditional market shares.

API Sourcing and Supply Chain Resilience:
The recent global supply chain disruptions, exemplified during the COVID-19 pandemic, spurred increased emphasis on securing API sources. Suppliers investing in domestic API manufacturing or diversified sources aim to mitigate shortage risks.

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Regulatory and Patent Landscape

Primidone, being a generic and off-patent drug, faces minimal patent restrictions, facilitating multiple manufacturers’ entry. Nonetheless, regulatory approval processes differ across regions, influencing supplier market access and product availability.

Manufacturers must adhere to strict documentation, bioequivalence, and manufacturing standards to maintain approval status. Governments sometimes mandate stockpiles or strategic reserves for critical drugs like primidone, influencing supplier participation.

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Conclusion

The supply landscape for MYSOLINE (primidone) is characterized by a mixture of large generic manufacturers and regional producers. Major suppliers such as Mylan (through its legacy Meda operations) and Apotex’s Genus Pharmaceuticals dominate in key markets, supported by regional players in Asia, Latin America, and Africa. Despite the presence of multiple suppliers, supply chain vulnerabilities continue, partly due to manufacturing limitations, API sourcing challenges, and market demand shifts.

Stakeholders must monitor regulatory updates, manufacturing capacity, and geopolitical influences to ensure continuous, reliable access to primidone.

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Key Takeaways

• Mylan (formerly Meda) and Apotex's Genus are among the primary global suppliers of primidone.
• The generic drug's supply is susceptible to manufacturing disruptions, API shortages, and regulatory changes.
• Regional suppliers, especially in Asia and emerging markets, play a crucial role in supplementing supply.
• Diversification of API sources and strategic inventory reserves can mitigate shortages.
• Evolving market competition from newer AEDs may influence long-term demand for primidone.

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Frequently Asked Questions (FAQs)

1. Who are the leading global suppliers of MYSOLINE (primidone)?
   Mylan, through its acquisition of Meda Pharmaceuticals, remains a primary supplier in North America and Europe. Apotex’s Genus Pharmaceuticals also supplies primidone in North America and Europe. Numerous regional manufacturers, particularly in India and China, produce generic primidone for emerging markets.

2. Are there recent supply chain disruptions affecting primidone availability?
   Yes. Global API shortages, manufacturing plant inspections, and logistics disruptions—exacerbated during the COVID-19 pandemic—have occasionally constrained primidone supply, emphasizing the need for diversified manufacturing sources.

3. How does regional regulation impact primidone suppliers?
   Different regulatory agencies (FDA, EMA, DCGI, etc.) impose stringent approval, manufacturing, and quality standards. Suppliers must comply to maintain market access, which can influence production capacity and supply stability.

4. What are the main risks facing primidone supply chains?
   Supply risks include API shortages, manufacturing capacity limitations, regulatory delays, geopolitical factors, and shifts in market demand due to evolving treatment guidelines favoring newer AEDs.

5. Will the demand for primidone decline due to newer epilepsy drugs?
   Although newer AEDs are preferred in some markets due to better tolerability, primidone remains essential in regions where cost-effective, generic options are preferred or where access to newer therapies is limited. Supply will continue to be vital for specific patient populations.

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References

[1] U.S. Food and Drug Administration. Drug Approvals and Markings. (2022).
[2] European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion. (2021).
[3] International Pharmaceutical Regulators Forum. API manufacturing guidelines. (2020).
[4] IQVIA. Global Pharmaceutical Market Report. (2022).
[5] WHO Model List of Essential Medicines. (2023).