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Suppliers and packagers for generic pharmaceutical drug: VORASIDENIB
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VORASIDENIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-728-40 | 1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-08-07 |
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-879-10 | 1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-08-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vorasidenib
Introduction
Vorasidenib, a potent oral targeted therapy, is developed to inhibit mutant isocitrate dehydrogenase (IDH) enzymes, primarily IDH1 and IDH2. Its development is concentrated primarily within the oncology segment, especially for treating gliomas harboring IDH mutations. As its clinical pathway advances, understanding the landscape of suppliers—ranging from raw material providers to manufacturing partners—is crucial for stakeholders involved in drug development, manufacturing, and distribution. This article examines the current suppliers and supply chain considerations pertinent to vorasidenib, highlighting recent developments and strategic implications.
Overview of Vorasidenib and Its Market Context
Vorasidenib is an investigational drug developed by Servier and Codexis, with ongoing clinical trials targeting low-grade glioma patients with IDH mutations. The molecule exemplifies precision medicine, leveraging biomarkers to improve therapeutic efficacy. Its supply chain encompasses multiple stages, including active pharmaceutical ingredient (API) production, formulation, and distribution.
Given the complexity of its synthesis and the critical need for high-purity components, identifying reliable suppliers for vorasidenib's raw materials and manufacturing services is pivotal. As of now, the product remains investigational, with No approvals for commercial distribution, which influences the competitive landscape of its suppliers.
API Manufacturing Supply Chain for Vorasidenib
1. Active Pharmaceutical Ingredient (API) Suppliers
The heart of vorasidenib’s supply chain lies in its API production. The synthesis route involves complex organic chemistry, requiring specialized chemical intermediates and catalysts. Currently, the API manufacturers are primarily research-focused or part of larger pharmaceutical manufacturers facilitating clinical trials.
Key players in API supply include:
- Servier: As the originator, Servier oversees API development and potentially produces its API in-house or via strategic partners.
- Contract Manufacturing Organizations (CMOs): Several CMOs with expertise in complex organic synthesis may serve as the API suppliers. These include:
- WuXi AppTec: A global leader in API production, known for high-quality process development and manufacturing scale-up.
- CordenPharma: Offers synthesis and production of complex APIs, with capabilities tailored for oncology drugs.
- BASF: Recognized for custom synthesis services, particularly for niche chemical intermediates.
These contracted suppliers often operate under strict confidentiality and quality control to meet clinical trial standards like Good Manufacturing Practice (GMP).
2. Intermediates and Raw Material Suppliers
The synthesis pathway of vorasidenib involves specialized intermediates sourced from chemical suppliers with strict quality standards. These include:
- Specialty chemical providers that supply chiral intermediates.
- Catalysts and reagents exclusive to specific synthetic steps.
Suppliers such as Sigma-Aldrich (a division of Merck) are common sources of chemicals used in API synthesis, although unique intermediates may come from specialized custom manufacturers.
Formulation and Packaging Suppliers
Though development-stage, vorasidenib’s solid dosage form will likely be produced in partnership with pharmaceutical formulators. The packaging suppliers for clinical-grade material include companies specializing in primary and secondary packaging compliant with regulatory standards (e.g., Schott, West Pharmaceutical Services).
Supply Chain Challenges and Considerations
- High Purity and Quality Standards: Strict adherence to GMP is essential, especially to support clinical trials. This limits the pool of eligible API manufacturers.
- Limited Number of Specialized Suppliers: Due to the complexity of synthesis, few companies possess the capabilities needed for vorasidenib’s API production.
- Supply Chain Disruptions: Raw material shortages or geopolitical issues can impact supply stability, crucial in clinical trials and potential commercialization.
- Regulatory Compliance: Suppliers must meet rigorous standards outlined by authorities like the FDA and EMA, adding constraints to supplier selection.
Strategic Implications for Stakeholders
- Development Organizations: Should diversify supplier relationships to mitigate risks tied to limited manufacturing capacity.
- Investors: Should monitor supplier stability, particularly for API providers, as delays can affect clinical timelines and market entry.
- Manufacturers: Need to establish robust quality assurance processes to meet regulatory expectations and ensure seamless supply for clinical and future commercial phases.
Future Outlook
As vorasidenib advances through clinical stages, supply chain dynamics are poised for evolution. Transition from trial supplies to commercial manufacturing typically expands supplier networks, potentially engaging larger CMOs and possibly integrating vertical manufacturing. Strategic partnerships with established API producers like WuXi AppTec and CordenPharma could solidify supply stability and regulatory compliance.
Moreover, the increasing importance of supply chain transparency and sustainability is influencing supplier selection, with stakeholders seeking environmentally responsible and resilient partners.
Conclusion
While vorasidenib remains investigational, its supply chain—centered on high-quality API manufacturers and intermediates—plays a critical role in its clinical development and eventual market penetration. The limited pool of specialized API suppliers, coupled with stringent quality requirements, underscores the need for strategic sourcing and robust supply chain management. Monitoring ongoing collaborations and supply chain innovations will be vital to capitalize on the drug’s therapeutic potential.
Key Takeaways
- Vorasidenib’s supply chain is primarily defined by specialized API manufacturing, with key collaborations likely involving companies such as WuXi AppTec and CordenPharma.
- Ensuring high purity, GMP compliance, and supply chain resilience are top priorities, especially during clinical development phases.
- The limited number of capable API suppliers underscores the importance of strategic partnerships and diversified sourcing.
- Raw material sourcing and synthesis complexity pose ongoing challenges, necessitating close supplier oversight.
- Transitioning from clinical to commercial supply will likely involve scaled-up manufacturing partnerships and expanded supplier networks.
FAQs
1. Who are the primary API suppliers for vorasidenib?
As of now, specific API suppliers have not been publicly disclosed. Leading contract manufacturers like WuXi AppTec and CordenPharma are potential candidates due to their expertise in complex oncology APIs.
2. How does the complexity of vorasidenib’s synthesis influence its supply chain?
The complex organic synthesis route limits the number of qualified manufacturers, requiring specialized intermediates and strict quality controls, which constrains supplier options and increases dependency on a few high-capacity providers.
3. Will vorasidenib’s supply chain change upon approval and commercialization?
Yes, commercialization typically necessitates scaling up production, leading to expanded supplier networks, possibly involving larger manufacturing facilities and geographic diversification to ensure supply security.
4. Are there geopolitical risks affecting vorasidenib’s supply chain?
Potential risks include trade restrictions, raw material shortages, and disruptions—especially if key suppliers are concentrated in geopolitically sensitive regions. Diversification strategies are essential to mitigate these risks.
5. How can stakeholders ensure supply chain resilience for investigational drugs like vorasidenib?
By establishing multiple supplier relationships, maintaining strategic inventory buffers, closely monitoring regulatory compliance, and engaging in early planning for scale-up manufacturing.
Sources
[1] ClinicalTrials.gov. Vorasidenib clinical trials.
[2] WuXi AppTec. API development and manufacturing capabilities.
[3] CordenPharma. Custom synthesis and complex API manufacturing services.
[4] Sigma-Aldrich. Chemical intermediates and reagents.
[5] Servier. Research and development disclosures on vorasidenib.
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