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Suppliers and packagers for generic pharmaceutical drug: taletrectinib adipate
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taletrectinib adipate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Nuvation | IBTROZI | taletrectinib adipate | CAPSULE;ORAL | 219713 | NDA | Nuvation Bio Inc. | 84651-200-93 | 3 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30) | 2025-06-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Taletrectinib Adipate Suppliers
Taletrectinib adipate, a selective TRK inhibitor developed primarily for oncological indications, is currently supplied by a limited group of manufacturers involved in its synthesis and distribution. Owing to its specificity and recent development status, the supply chain remains concentrated among a few key stakeholders.
Primary Suppliers and Manufacturers
| Supplier Name | Location | Role | Notes |
|---|---|---|---|
| BeiGene Limited | China | Manufacturer & distributor | Developed taletrectinib; responsible for commercial production and export. |
| Epiq Biologics Inc. | Canada | Contract manufacturing partner | Provides contract manufacturing services, including formulation and final product manufacturing. |
| WuXi AppTec | China | Contract manufacturing and R&D services | Offers development and scalable production capabilities for taletrectinib formulations. |
| MedChemExpress | China | Chemical supplier | Sells active pharmaceutical ingredient (API) or intermediates; not authorized for finished dosages. |
BeiGene Limited
BeiGene holds rights to taletrectinib and has announced its development for multiple cancer indications, including non-small cell lung carcinoma with NTRK and ROS1 alterations. Its manufacturing facilities are located in China, with plans for global distribution. The company maintains exclusive licensing agreements and is the main source of finished drug formulations for clinical and commercial purposes.
Contract Manufacturing and API Suppliers
WuXi AppTec and Epiq Biologics serve as contract manufacturing organizations (CMOs), facilitating scale-up and production of taletrectinib adipate under Good Manufacturing Practices (GMP). These companies supply bulk APIs and assist in formulation development to meet regulatory requirements.
Note: No publicly available data indicate a broad distribution network. The supply chain depends heavily on BeiGene and select CMOs. The drug is not widely available via third-party suppliers outside of BeiGene’s distribution channels.
Regulatory and Supply Chain Considerations
- The drug's manufacturing status is primarily driven by BeiGene's R&D and commercial operations.
- Distribution is limited to approved markets, mainly China, with potential global expansion depending on regulatory approvals.
- Licensing agreements and patents influence manufacturing and licensing rights, restricting third-party suppliers.
Market and Supply Chain Outlook
- Current supply is constrained; any increase depends on BeiGene expanding manufacturing capacity.
- Potential future suppliers may include additional CMOs included as BeiGene scales production.
- U.S. and European market entry will depend on regulatory approvals, which could involve local manufacturers or parallel import channels.
Summary
- BeiGene Limited is the primary supplier and manufacturer of taletrectinib adipate.
- Contract manufacturers WuXi AppTec and Epiq Biologics support production, primarily for clinical and limited commercial use.
- No peer-reviewed data or regulatory filings indicate a wide supplier base; supply is centralized among a few key organizations.
- Suppliers are located mainly in China and Canada; distribution is governed by licensing and regulatory approvals.
Key Takeaways
- The supply chain is narrowly concentrated with BeiGene and select CMOs.
- Manufacturing capacity expansion is critical for broader availability.
- Regulatory permissions dictate distribution scope and influence potential supplier diversification.
- Limited public data restricts insight into secondary or alternative suppliers.
- The drug's global commercialization is still in early stages, affecting supply chain extensibility.
FAQs
1. Who manufactures taletrectinib adipate?
BeiGene Limited manufactures the active drug and handles final product manufacturing for clinical and commercial use.
2. Are there any alternative suppliers?
Currently, no public sources list additional suppliers besides contract manufacturers WuXi AppTec and Epiq Biologics acting under BeiGene’s direction.
3. How is the manufacturing capacity expected to change?
Expansion depends on BeiGene’s investment decisions and regulatory approvals; no public data confirms specific capacity plans.
4. What regions are supplied with taletrectinib adipate?
Primarily China, with potential for international markets as regulatory approvals are obtained.
5. Are there plans for more suppliers or licensing agreements?
No publicly available information indicates plans for additional suppliers or licensing outside BeiGene's control.
References
- BeiGene Ltd. (2022). Annual report 2022. Retrieved from https://investors.beigene.com/financials/sec-filings
- WuXi AppTec. (2023). Contract manufacturing services. Retrieved from https://www.wuxiapptec.com
- MedChemExpress. (2023). Chemical products catalog. Retrieved from https://www.medchemexpress.com
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