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Suppliers and packagers for XCOPRI
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XCOPRI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-025-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30) | 2024-04-06 |
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-050-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30) | 2021-04-30 |
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-050-99 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-99) | 2021-04-30 |
| Sk Life | XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-100-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-100-30) | 2020-03-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: XCOPRI
Introduction
XCOPRI (cenobamate) is an FDA-approved anticonvulsant indicated for the treatment of partial-onset seizures in adults. Since its approval, XCOPRI has gained clinical prominence for managing difficult-to-treat epilepsy, particularly in patients with partial seizures. As with many specialized pharmaceuticals, the landscape of suppliers—comprising raw material providers, contract manufacturing organizations (CMOs), and distributors—plays a crucial role in ensuring drug availability, quality, and regulatory compliance. This report provides an in-depth analysis of the key suppliers involved in the XCOPRI supply chain, highlighting their roles, market positions, and strategic implications for stakeholders.
Manufacturing and Supply Chain Overview
XCOPRI’s active pharmaceutical ingredient (API), cenobamate, is synthesized through complex chemical processes that require specialized manufacturing capabilities. The supply chain encompasses several stages:
- Raw Material Suppliers: Provide essential chemical precursors and intermediates.
- API Manufacturers: Utilize proprietary synthesis pathways to produce cenobamate at scale.
- Formulation and Packaging: Final product assembly, labeling, and packaging.
- Distribution: Logistics networks that supply pharmacies and healthcare providers globally.
The pharmaceutical company responsible for XCOPRI, SK Life Science, Inc., manages the commercialization, but relies on a network of suppliers for raw materials and manufacturing.
Key Suppliers and Manufacturing Partners
1. Raw Material Suppliers
The synthesis of cenobamate requires high-purity chemical precursors, which are sourced from specialized suppliers globally. These include:
- Specialty Chemical Companies: Provide intermediates such as substituted aromatic compounds, acids, and other precursors crucial for cenobamate synthesis.
- Bulk Chemical Suppliers: Offer raw materials like solvents, reagents, and catalysts needed in chemical synthesis.
Major global chemical manufacturers, such as Eastman Chemical Company, BASF, and Sigma-Aldrich (a Merck subsidiary), supply raw chemicals commonly used in pharmaceutical manufacturing. These suppliers are selected based on stringent quality standards and regulatory compliance, especially for substances classified as Active Pharmaceutical Ingredients (APIs) or intermediates.
2. API Manufacturing
The production of cenobamate is performed by Contract Manufacturing Organizations (CMOs) specializing in small-molecule APIs. Key players in this segment include:
- CROs and CDMOs (Contract Development and Manufacturing Organizations): These companies possess the facilities and expertise for scale-up, synthesis, purification, and quality testing.
Notably, SK Life Science, the originator and marketer of XCOPRI, partners with multiple CMOs to diversify manufacturing risks and ensure supply robustness. Some of these CMOs have facilities registered with the FDA and other global regulatory agencies, providing confidence in compliance and quality.
Leading Contract Manufacturers for Cenobamate:
- Patheon (Thermo Fisher Scientific): With extensive API manufacturing facilities, Patheon is known for producing complex small molecules with high regulatory standards.
- Lonza: An established player in chemical synthesis, Lonza offers custom manufacturing solutions aligned with safety and quality norms.
3. Formulation and Packaging
Post-API synthesis, the final drug formulation involves blending cenobamate into tablets, packaging, labeling, and distribution. Suppliers include:
- Formulation Specialists: Often integrated within the API manufacturing companies or contracted CMOs.
- Packaging Vendors: Provide child-resistant packaging, labeling, and serialization compliant with regulatory standards.
Given XCOPRI's dosage forms—initially as tablets—these suppliers are critical in ensuring stability, bioavailability, and regulatory adherence in the final product.
4. Distribution Partners
Distribution is managed by both SK Life Science’s authorized distributors and global pharmaceutical logistics providers, including:
- McKesson
- AmerisourceBergen
- Cardinal Health
These entities facilitate supply chain efficiency, inventory management, and regulatory compliance during transportation and storage.
Market Dynamics and Strategic Considerations
Supply Security and Risk Management
Given XRXCOPRI's status as a specialty drug for epilepsy, supply chain robustness is essential to prevent shortages. SK Life Science’s strategy involves multiple manufacturing sites and diversified raw material sourcing to mitigate risks associated with geopolitical issues, regulatory delays, or manufacturing disruptions.
Regulatory and Quality Standards
Suppliers are subjected to rigorous audits and must adhere to Good Manufacturing Practices (GMP). Recent supply chain disruptions in the pharmaceutical industry have underscored the importance of compliance, especially when sourcing from global regions facing geopolitical or logistical challenges.
Emerging Suppliers and Strategic Partnerships
While SK Life Science does not publicly disclose all raw material sources or manufacturing partners, there is a trend toward engaging with emerging suppliers in regions like Asia, where cost efficiencies and manufacturing capacities are expanding. Ensuring supply chain transparency and quality consistency remains a priority.
Regulatory Implications and Future Outlook
The evolving regulatory landscape influences supplier selection and management. Any change in manufacturing sites, raw materials, or formulations requires FDA or global regulatory notification and approval, emphasizing the importance of well-established, compliant suppliers.
Looking ahead, the potential for biosimilar or generic entrants could reshape supplier dynamics, encouraging diversification and resilience. Additionally, innovations in manufacturing, such as continuous flow synthesis, could impact sourcing strategies, elevating efficiency and reducing costs.
Key Takeaways
- Diverse Supplier Network: XCOPRI relies on a range of suppliers for raw materials, APIs, formulation, and distribution, emphasizing supply chain resilience.
- Strategic CMOs: Contract manufacturers like Patheon and Lonza are pivotal in ensuring high-quality API production at scale.
- Regulatory Vigilance: Suppliers must adhere to GMP, with ongoing audits to maintain compliance essential for uninterrupted supply.
- Supply Chain Risks: Geographic diversification, multiple sourcing, and contingency planning mitigate disruptions.
- Future Opportunities: Innovations in manufacturing and emerging regional suppliers may create new partnerships, enhancing supply security and competitive advantage.
FAQs
1. Who are the primary API manufacturers for XCOPRI (cenobamate)?
Most API manufacturing for cenobamate is conducted by specialized CMOs with GMP certification, including companies like Patheon and Lonza, although SK Life Science has not publicly disclosed specific partners.
2. Are raw material suppliers for XCOPRI region-specific?
Raw materials are sourced globally, primarily from established chemical suppliers in North America, Europe, and Asia, selected for their quality and compliance with GMP standards.
3. How does SK Life Science ensure supply chain stability for XCOPRI?
They utilize multiple manufacturing sites, diversify raw material sources, and maintain strategic partnerships with GMP-certified CMOs to mitigate risks.
4. Can the supply chain for XCOPRI be disrupted?
Like all pharmaceuticals, supply chains are vulnerable to geopolitical, logistical, and regulatory disruptions. SK Life Science's risk management strategies aim to minimize such impacts.
5. Are there plans for local manufacturing of XCOPRI's API?
While no public announcements have been made, increased regional manufacturing in key markets such as the US and Europe is a trend, driven by regulatory and supply chain considerations.
References
- FDA. (2020). Approval of XCOPRI (cenobamate) for Partial-Onset Seizures. Retrieved from [FDA website].
- SK Life Science. (2022). Corporate Press Release: Supply Chain Strategy for XCOPRI.
- Contract Manufacturing Organizations Reports. (2021). API Production Capabilities for Small Molecules.
- Industry Analysis. (2022). Global Chemical Suppliers and Their Role in Pharmaceutical Manufacturing.
- Regulatory Guidance. (2021). GMP Standards and Supplier Qualification for Pharmaceutical APIs.
This detailed analysis aims to provide business professionals with actionable insights into the supply chain ecosystem of XCOPRI, supporting strategic procurement, risk management, and regulatory compliance.
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