Suppliers and packagers for CELONTIN

CELONTIN

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	CELONTIN	methsuximide	CAPSULE;ORAL	010596	NDA	Parke-Davis Div of Pfizer Inc	0071-0525-24	100 CAPSULE in 1 BOTTLE (0071-0525-24)	1957-02-08

Suppliers for the Pharmaceutical Drug: CELONTIN

Last updated: August 16, 2025

Introduction

CELONTIN, the brand name for primidone, is an anticonvulsant medication primarily used in the management of epilepsy and tremors. Since its FDA approval in the 1950s, CELONTIN has become a staple in neurologic pharmacotherapy. Its widespread use has fostered a broad network of suppliers ranging from original manufacturers to generic producers globally. For stakeholders in pharmaceutical procurement, understanding the sourcing landscape of CELONTIN is critical for strategic planning, pricing analysis, and regulatory compliance.

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Overview of CELONTIN (Primidone)

Primidone is a barbiturate derivative that exhibits anticonvulsant and sedative properties. It is available both as a branded formulation (CELONTIN) and as a generic drug, with multiple manufacturers producing their versions post patent expiry. The drug’s stability, established manufacturing protocols, and clinical significance make it a staple in epilepsy management.

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Original Manufacturers and Patent Holders

CELONTIN was originally developed and marketed by G.D. Searle & Co., which became part of Pfizer Inc. in 2004. Pfizer held the rights to the brand and distributed CELONTIN globally for decades. Post patent expiration, Pfizer's control over the brand diminished, paving the way for market entry by generic manufacturers.

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Generic Drug Suppliers and Major Manufacturers

1. Teva Pharmaceutical Industries Ltd.
   As a leading generic manufacturer, Teva produces primidone tablets under various labels, leveraging its extensive global distribution network. Teva's focus on cost-effective generics makes it a pivotal player in the CELONTIN supply chain.

2. Mylan N.V. (Now part of Viatris)
   Mylan has long been known for producing high-quality generics, including primidone. Its global reach ensures continued availability, especially in markets where cost sensitivity is high.

3. Sandoz (A Novartis division)
   Sandoz manufactures primidone as part of its broad portfolio of off-patent medications, serving various international markets, particularly in Europe and emerging economies.

4. Sun Pharmaceutical Industries Ltd.
   Sun Pharma supplies primidone to multiple regions, including North America, Asia, and Africa, often at competitive prices, targeting both institutional and retail channels.

5. APOTEX Inc.
   An established Canadian generic producer, APOTEX manufactures primidone, emphasizing quality standards compliant with FDA and Health Canada regulations.

6. Other regional manufacturers
   Several regional and local pharmaceutical firms also produce primidone, especially in markets with less stringent patent enforcement or where local manufacturing is incentivized.

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Manufacturing and Supply Chain Considerations

• Manufacturing Standards:
  Suppliers must adhere to Good Manufacturing Practices (GMP), regulated by agencies such as the FDA (USA), EMA (Europe), and KFDA (South Korea). GMP compliance ensures drug safety and efficacy.

• Regulatory Approvals:
  Suppliers need to secure necessary approvals from pertinent health authorities to market primidone, influencing the supply chain’s reliability.

• Pricing and Market Dynamics:
  The entry of multiple generic producers has driven down prices, increasing access but also intensifying competition. Price fluctuations are influenced by raw material costs, regulatory changes, and supply chain disruptions.

• Capacity and Supply Risks:
  Limited manufacturing capacity or raw material shortages can impact supply continuity. Suppliers with diversified manufacturing sites mitigate these risks.

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Market Trends and Emerging Suppliers

• Biopharmaceutical Innovations:
  Although primidone is an established molecule, ongoing research into novel anticonvulsants and tremor therapies may influence future demand.

• Global Expansion:
  Developing markets witness an increasing influx of generic primidone, with suppliers expanding their presence to meet unmet needs in neurology.

• Supply Chain Resilience:
  Recent disruptions, such as those caused by the COVID-19 pandemic, highlighted the necessity for diversified supplier networks and strategic inventory management.

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Implications for Stakeholders

• Healthcare Providers:
  Should verify supplier reliability and product authenticity to ensure patient safety.

• Pharmaceutical Distributors:
  Must establish relationships with multiple suppliers to secure consistent supply and competitive pricing.

• Regulatory Agencies:
  Monitor geopolitical and economic factors influencing supplier stability and comply with import/export controls.

• Investors and Business Strategists:
  Analyze market share and supplier stability to forecast prices and identify growth opportunities in generic primidone markets.

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Key Takeaways

• Multiple domestic and international manufacturers supply primidone, including major players like Teva, Viatris (Mylan), Sandoz, and Sun Pharma.
• The post-patent landscape has led to increased market competition, reducing prices while expanding access to CELONTIN generics globally.
• Regulatory compliance and manufacturing quality are critical for supply stability; GMP standards enforce consistent quality.
• Supply chain resilience hinges on diversified manufacturing footprints and raw material sourcing.
• Market dynamics will continue to evolve with emerging therapies and geopolitical factors, impacting supplier availability and pricing.

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FAQs

1. Who are the primary global suppliers of CELONTIN (primidone)?
Major suppliers include Teva, Viatris (formerly Mylan), Sandoz, Sun Pharma, and APOTEX, each providing generic primidone across different regions.

2. Is CELONTIN still protected by patents?
No. The original patent expired decades ago, allowing multiple generics to enter the market, decreasing prices and increasing availability.

3. How can healthcare providers ensure the quality of primidone supplied?
By sourcing from suppliers compliant with GMP and regulatory approvals from agencies like the FDA or EMA, and verifying batch testing and certificates of analysis.

4. What factors influence the supply stability of primidone?
Manufacturing capacity, raw material availability, regulatory changes, geopolitical stability, and global supply disruptions are key factors.

5. Are there regional differences in primidone suppliers?
Yes. Certain suppliers dominate specific markets due to regulatory, economic, or logistical advantages, with emerging markets often relying on local or regional producers.

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References

[1] Food and Drug Administration (FDA). "Generic Drug Review and Approval." FDA.gov.
[2] European Medicines Agency (EMA). "Regulatory framework for pharmaceuticals." EMA.europa.eu.
[3] Market research reports on anticonvulsant drugs and generic pharmaceuticals.
[4] World Health Organization (WHO). "Prequalification of Medicines." WHO.int.
[5] Company Annual Reports (Teva, Viatris/Mylan, Sandoz, Sun Pharma).

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This analysis provides a comprehensive understanding of the key suppliers and market dynamics surrounding CELONTIN (primidone), enabling stakeholders to make informed procurement, investment, or clinical decisions.