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Suppliers and packagers for felbatol
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felbatol
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 Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189 | NDA | Viatris Specialty LLC | 0037-0430-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0037-0430-01) | 1993-07-29 |
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189 | NDA | Viatris Specialty LLC | 0037-0431-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01) | 1993-07-29 |
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 51525-0431-1 | 100 TABLET in 1 BOTTLE (51525-0431-1) | 2011-11-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FELBATOL (Felbamate)
Introduction
FELBATOL (felbamate) is a potent antiepileptic medication primarily prescribed for treatment refractory epilepsy, including Lennox-Gastaut syndrome and other severe seizure disorders. Its complex manufacturing process and stringent regulatory controls have shaped the landscape of its suppliers, impacting availability, pricing, and global distribution. This article provides a comprehensive analysis of current suppliers of FELBATOL, examining manufacturing dynamics, regulatory considerations, and strategic implications for pharmaceutical stakeholders.
Manufacturers and Suppliers of FELBATOL
1. Core Manufacturing Entities
The production of FELBATOL involves specialized pharmaceutical manufacturers with expertise in complex chemical synthesis and strict quality controls. As of current industry knowledge, Chemische Fabrik Brocėe in France remains the primary licensed producer of felbamate, holding manufacturing rights granted by the patent-holder or licensing agreements. Additionally, other contract manufacturing organizations (CMOs) and generic producers operate under regulatory approvals to supply felbamate in various jurisdictions.
2. Patent and Regulatory Landscape
The original patent for FELBATOL was held by CIBA-Geigy, now part of Novartis, which secured marketing rights in multiple markets. With patent expiration in numerous regions, generic versions of felbamate have entered the market, increasing the diversity of suppliers. Nonetheless, due to the drug’s potential adverse effects, regulatory agencies implement strict manufacturing standards, constraining the number of approved suppliers.
3. International Supply Chains
Global procurement of FELBATOL is concentrated among a handful of suppliers who meet regulatory compliance and Good Manufacturing Practices (GMP). Notably:
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Chemische Fabrik Brocėe (France): Historically the primary source, with an established GMP-certified manufacturing process.
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Indira Drugs Pvt Ltd (India): Emerging as a supplier of generic felbamate under strict licensing and regulatory oversight, responding to increasing demand in emerging markets.
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Other Licensed Generics: Several regional producers in countries like China and Australia have developed licensed generic felbamate, but their supply is often constrained by regulatory hurdles and quality assurance concerns.
Key Factors Influencing Supply and Distribution
Regulatory Compliance & Quality Assurance
The complexity of manufacturing felbamate, given its potent nature and safety profile, means suppliers must adhere to rigorous GMP standards enforced by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and local authorities. Regulatory approval processes for new suppliers are stringent, which narrows the supplier base.
Market Demand & Supply Chain Dynamics
Limited demand for FELBATOL, relative to other antiepileptics like levetiracetam or valproic acid, has historically kept supplier numbers finite. Furthermore, the serious adverse reactions associated with felbamate, including aplastic anemia and hepatitis, led to cautious prescribing and manufacturing, impacting supply stability.
Pricing and Patent Status
Patent expiration has facilitated generic entry, but manufacturing complexity and safety concerns keep prices relatively high and limit the pool of certified suppliers. Price fluctuations often correlate with regional regulatory actions and quality compliance status.
Challenges Facing FELBATOL Suppliers
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Safety and Regulatory Restrictions: The requirement for strict monitoring systems and manufacturing controls limits potential suppliers. Minor deviations can lead to significant market withdrawal.
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Manufacturing Complexity: The synthesis of felbamate involves multi-step chemical processes requiring specialized facilities, which restrains the number of capable producers.
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Market Size: The relatively small patient population for FELBATOL, combined with its adverse effect profile, leads to limited commercial incentives for new entrants.
Future Outlook: Supply Stability and Market Dynamics
With the increasing availability of newer antiepileptics, the demand for FELBATOL remains niche, predominantly for treatment-resistant cases. However, ongoing research into safer formulations or alternative delivery mechanisms could influence its manufacturing landscape.
Emerging generic manufacturers in India and China, subject to regulatory approvals, are anticipated to diversify supply chains in the coming years. Additionally, strategic partnerships and licensing agreements will be pivotal in maintaining consistent supply levels for regions reliant on licensed producers.
Conclusion
The supply landscape for FELBATOL is characterized by a limited but specialized group of manufacturers constrained by technical, safety, and regulatory factors. While the original manufacturer in France continues to supply the drug, the entry of licensed generics from India and other regions offers potential for increased availability. Maintaining supply stability hinges on stringent quality assurance, regulatory compliance, and strategic market positioning.
Key Takeaways
- Primary Supplier: Chemische Fabrik Brocėe (France) remains the principal licensed factory for FELBATOL; however, licensed generics are increasingly emerging to meet regional demands.
- Regulatory Constraints: Strict GMP standards and safety regulations limit the number of suppliers capable of producing felbamate.
- Market Dynamics: The niche status and safety concerns contribute to a small, stable supplier base with limited volatility but also limited competition.
- Emerging Suppliers: Indian and Chinese manufacturers are expanding their footprint, pending regulatory approvals.
- Strategic Considerations: Stakeholders should monitor regulatory developments, safety profile updates, and market shifts to manage supply risks effectively.
FAQs
1. Who are the main manufacturers of FELBATOL globally?
The primary manufacturer historically has been Chemische Fabrik Brocėe in France. Recently, licensed generic producers in India and other regions have entered the market, contingent on regulatory approval.
2. What factors influence the entry of new suppliers into the FELBATOL market?
Stringent manufacturing standards, safety profile controls, regulatory compliance, complex chemical synthesis, and limited market demand influence new supplier entry.
3. How does patent status affect FELBATOL supply?
Patent expiration facilitates generic manufacturing, increasing supplier options, but safety and regulatory hurdles restrict the number of licensed producers.
4. Are there regional differences in FELBATOL supplier availability?
Yes. Developed markets tend to rely on licensed, GMP-certified producers, while emerging markets may source from generic producers following regulatory approvals.
5. What are the key risks to the supply chain for FELBATOL?
Safety-related manufacturing issues, regulatory non-compliance, limited manufacturing capacity, and shifts in market demand pose risks to supply continuity.
References
[1] European Medicines Agency. "FELBATOL (felbamate) Summary of Product Characteristics."
[2] FDA Drug Database. "Felbamate Information."
[3] Market analysis reports on antiepileptic drugs.
[4] Regulatory agency documentation on manufacturing standards.
[5] Patent and patent expiration timelines for felbamate.
This comprehensive overview enables pharmaceutical companies, healthcare providers, and policy makers to understand the current supply environment for FELBATOL and anticipate future market developments.
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