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Suppliers and packagers for XENAZINE
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XENAZINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-421-01 | 112 TABLET in 1 BOTTLE (67386-421-01) | 2008-11-24 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-422-01 | 112 TABLET in 1 BOTTLE (67386-422-01) | 2008-11-24 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-421-12 | 112 TABLET in 1 BOTTLE (68682-421-12) | 2015-07-20 |
| Bausch | XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-422-25 | 112 TABLET in 1 BOTTLE (68682-422-25) | 2015-07-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: XENAZINE ( tetrabenazine)
Introduction
XENAZINE (tetrabenazine) is a prescription medication primarily used to treat chorea associated with Huntington’s disease—a neurological disorder characterized by involuntary movements and cognitive decline. As a critical therapeutic agent, the sourcing and supply chain of XENAZINE are of paramount importance to ensure consistent availability for patients worldwide. This comprehensive analysis examines the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics surrounding XENAZINE.
Understanding XENAZINE and Its Manufacturing Pathway
XENAZINE is a branded formulation of tetrabenazine, developed and marketed predominantly by Teva Pharmaceutical Industries. The drug's formulation involves complex chemistry and stringent manufacturing processes, necessitating a highly regulated supply chain. The active pharmaceutical ingredient (API)—tetrabenazine—is synthesized through multi-step chemical processes, with the entire supply chain involving sourcing of raw materials, synthesis, formulation, packaging, and distribution.
The pharmaceutical industry’s reliance on robust supply chains is particularly critical for drugs treating neurological conditions like Huntington's disease, as delays or shortages can significantly impact patient health outcomes.
Primary Suppliers and Manufacturing Entities
1. Teva Pharmaceutical Industries
Teva is the primary source for XENAZINE. It holds the marketing authorization and is responsible for manufacturing and supplying the drug globally. Teva’s manufacturing facilities, compliant with Good Manufacturing Practices (GMP), are located mainly in Europe and North America, ensuring quality and regulatory adherence ([2]).
2. Active Pharmaceutical Ingredient (API) Suppliers
While Teva is the main manufacturer, like many large pharmaceutical firms, it relies on specialized chemical suppliers for its raw materials and intermediates. These suppliers produce the tetrabenazine API, often sourced from a network of API manufacturers that operate under strict quality standards.
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Specialized API manufacturers: Companies such as Hubei Huazhong Pharmaceutical Co., Jiangxi Kanion Pharmaceutical, and Tocris Bioscience are notable for producing similar or generic APIs and intermediates; however, their involvement in tetrabenazine is limited and often proprietary or confidential ([3]).
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Contract Manufacturing Organizations (CMOs): Teva may utilize third-party CMOs for specific manufacturing steps, especially for the API or final formulation. These CMOs are checked for compliance with international standards, including GMP.
3. Generic Manufacturers and Regional Suppliers
In response to patent expirations or regulatory approvals, regional generic manufacturers have emerged to produce tetrabenazine-based products:
- Sun Pharmaceutical Industries in India supplies generic tetrabenazine formulations.
- Mundipharma and Lundbeck have also expressed interest in similar neurological treatments, though their involvement in XENAZINE specifically is limited ([4]).
Regulatory and Supply Chain Considerations
The global supply of XENAZINE is influenced by regulatory approvals from agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional bodies. Regulatory compliance ensures that manufacturing facilities meet GMP standards, and it involves rigorous ongoing inspections.
The supply chain must also adapt to geopolitical factors, trade policies, and raw material availability, especially from Asian API manufacturers, which globally supply active ingredients for a wide range of drugs.
Market and Supply Chain Dynamics
The market for Huntington's disease treatments remains relatively niche but critical, creating a stabilized demand for XENAZINE. However, recent generic entries post-patent expiry and emerging biosimilars have increased competition that can disrupt supply patterns.
Supply shortages have occasionally been reported, often linked to manufacturing delays, regulatory inspections, or raw material scarcities. Such disruptions stress the importance of diversified supplier networks and strategic inventory management.
Emerging Trends Influencing Supplier Landscape
- Shift toward biosimilars and generics: As patents expire, regional players gain prominence, diversifying the supply chain.
- Vertical integration: Larger pharmaceutical companies like Teva aim for greater control over manufacturing and API sourcing to mitigate risks.
- Supply chain globalization: Dependency on Asian API manufacturers underscores the need for geopolitical risk management and quality assurance.
Conclusion
The supply of XENAZINE hinges primarily on Teva Pharmaceutical Industries as the principal manufacturer, with auxiliary input from specialized API suppliers, CMOs, and regional generic firms. Ensuring uninterrupted access requires robust supply chain management, regulatory compliance, and strategic supplier diversification. As the market for Huntington’s disease therapies evolves, suppliers' roles are likely to diversify further, emphasizing the importance of agility and quality assurance in maintaining stable supplies.
Key Takeaways
- Teva is the main supplier for XENAZINE, responsible for manufacturing and global distribution.
- API supply chains involve several Asian manufacturers, with Teva potentially relying on CrMs and unnamed API producers.
- Regulatory compliance underpins all manufacturing and supply activities, with GMP standards ensuring product quality.
- Supply risks stem from manufacturing delays, geopolitical issues, and raw material shortages, making supply chain diversification essential.
- Future trends point toward regional generic manufacturers gaining influence, alongside increased transparency and supply chain resilience.
FAQs
1. Who are the main suppliers of XENAZINE’s active ingredient?
Teva sources tetrabenazine API predominantly from specialized chemical manufacturers, often in Asia, though specific supplier names are proprietary. The company may also produce the API in-house at GMP-certified facilities.
2. Are there generic versions of XENAZINE available?
Yes, following patent expirations, several generic tetrabenazine products are available from regional manufacturers such as Sun Pharma and others in India and Europe.
3. How does supply chain regulation impact XENAZINE availability?
Strict adherence to GMP standards and regulatory approvals ensure quality but can also cause delays owing to inspections, compliance issues, or manufacturing disruptions.
4. What risks threaten the supply of XENAZINE?
Risks include manufacturing delays, raw material shortages, geopolitical factors, and regulatory hurdles, which can lead to shortages.
5. Are there plans to diversify or localize the supply chain for XENAZINE?
While specifics are confidential, industry trends suggest increasing localization and diversification to improve resilience, especially in light of recent global supply disruptions.
References
[1] Teva Pharmaceutical Industries. XENAZINE (tetrabenazine) product information. (2022).
[2] U.S. FDA. Approved Drug Products: XENAZINE. (2022).
[3] PharmTech. API manufacturing landscape for neurological drugs. (2021).
[4] GlobalData. Patent expirations and generic drug entry in neurological treatments. (2022).
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