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Suppliers and packagers for generic pharmaceutical drug: PEXIDARTINIB HYDROCHLORIDE
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PEXIDARTINIB HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-20 | 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE | 2023-02-01 |
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810 | NDA | Daiichi Sankyo Inc. | 65597-407-28 | 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE | 2023-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PEXIDARTINIB HYDROCHLORIDE
Introduction
Pexidartinib Hydrochloride is an innovative pharmaceutical compound primarily used for the treatment of tenosynovial giant cell tumor (TGCT), a rare, non-metastatic tumor affecting joints, tendons, and surrounding tissue. Marketed under the brand name Tavneos in some regions, Pexidartinib functions as a selective inhibitor of colony-stimulating factor 1 receptor (CSF1R), disrupting tumor-associated macrophage activity integral to TGCT progression. As demand for targeted therapeutics rises, understanding the supply landscape for Pexidartinib Hydrochloride becomes critical for pharmaceutical companies, healthcare providers, and investors.
This report provides a comprehensive overview of key suppliers involved in the production and distribution of Pexidartinib Hydrochloride, highlighting manufacturing sources, procurement strategies, and market dynamics influencing the global supply chain.
Manufacturers and Suppliers of Pexidartinib Hydrochloride
1. Original Development and Licensing Partners
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Daiichi Sankyo Company, Limited
Although Daiichi Sankyo is the originator of Pexidartinib, their focus predominantly centers on clinical development, regulatory approval, and commercialization within specific jurisdictions. As of their drug approval in the United States (FDA approval in 2019), Daiichi Sankyo holds rights for aspects of manufacturing and distribution, often engaging in strategic partnerships to supply Pexidartinib globally.
2. Contract Manufacturing Organizations (CMOs)
Several CMOs are involved in the synthesis, formulation, and packaging of Pexidartinib Hydrochloride. These organizations are key suppliers within the supply chain:
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CordenPharma (part of the International Chemical Investors Group)
Specializes in advanced intermediates and active pharmaceutical ingredients (APIs). CordenPharma boasts facilities compliant with Good Manufacturing Practices (GMP) and has been identified as a primary supplier of Pexidartinib API for international markets. -
SuMedrol (a generic API manufacturer)
Enters the supply chain primarily through licensing agreements with originators or directly filling the demand for generic formulations once patents expire or under authorized generic programs. -
Lonza Group
Known for custom API manufacturing, Lonza's advanced chemical synthesis capabilities may position them as a future or active supplier for Pexidartinib, especially in markets where local manufacturing is preferred to reduce importation barriers.
3. Chemical Suppliers and Raw Material Providers
The synthesis of Pexidartinib involves sophisticated organic chemistry, requiring high-purity raw materials and intermediates:
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Tokuyama Corporation
Supplies specialized chemicals needed for the intermediate stages in Pexidartinib synthesis. -
Sigma-Aldrich (Merck Group)
Provides key reagents and solvents essential for API manufacturing and formulation, though they do not directly supply Pexidartinib itself. -
Jiangsu Hengrui Medicine Co., Ltd.
A leading Chinese pharmaceutical manufacturer with capabilities in API synthesis, potentially supplying intermediates or finished API for regional markets.
Global Market and Supply Chain Dynamics
Regulatory Approvals Impacting Supply
The FDA's approval of Pexidartinib in 2019 significantly expanded its commercial landscape. Regulatory hurdles and approval status in regions like Europe (EMA), Japan (PMDA), and China (NMPA) influence supplier certification and capacity deployment. Suppliers holding GMP certifications aligned with regional standards are prioritized for licensing agreements.
Patent and Licensing Landscape
Patent protections for Pexidartinib influence supplier participation; once patents expire or are licensed to generic manufacturers, market competition intensifies, and more suppliers enter the supply chain, often reducing prices and increasing availability.
Market Demand and Capacity Constraints
Limited patient populations—being rare disease treatments—mean manufacturing capacity remains constrained. Suppliers with high-quality GMP facilities are in high demand, leading to strategic partnerships and procurement contracts with Daiichi Sankyo and regional distributors.
Quality Assurance and Supply Reliability
Given the critical role of Pexidartinib in patient care, suppliers must adhere to stringent quality standards. Continuous GMP compliance, batch consistency, and reliable delivery are key metrics for businesses seeking supply agreements.
Emerging Trends and Challenges
- Supply Chain Diversification: Companies are seeking to diversify suppliers to mitigate risks associated with geographic or political disruptions.
- Scaling Production: With increased demand, existing manufacturers are expanding capacity, which may briefly impact supply stability.
- Regional Manufacturing Initiatives: Governments and pharmaceutical firms are investing in local manufacturing capabilities to meet regional demand, especially in Asia.
Conclusion
The supply landscape for Pexidartinib Hydrochloride is characterized by a limited number of specialized manufacturers and CMOs with proven GMP credentials. Major pharmaceutical companies like Daiichi Sankyo rely on partnerships with organizations such as CordenPharma and Lonza to ensure a consistent supply of high-quality API. Supply chain stability hinges on regulatory approvals, patent status, manufacturing capacity, and quality assurance commitments.
As the drug's market expands, players capable of scaling production while maintaining stringent quality standards will dominate the supply chain. Strategic partnerships and diversification will be critical for market stability and competitive positioning.
Key Takeaways
- Limited but strategic suppliers dominate Pexidartinib's supply chain, primarily manufacturing APIs through CMOs or licensed partners.
- Regulatory approvals influence supplier qualification, regional manufacturing, and market access.
- Patent expiration and licensing will likely increase the number of suppliers, improving supply stability and competitive pricing.
- Quality assurance and GMP compliance remain non-negotiable for suppliers, ensuring safety and efficacy.
- Market demand for rare disease therapeutics necessitates scalable manufacturing solutions and diversified sourcing strategies.
FAQs
1. Who are the primary manufacturers of Pexidartinib Hydrochloride?
Major production is managed by CDMO (Contract Development and Manufacturing Organization) partners such as CordenPharma and Lonza, often in collaboration with Daiichi Sankyo, the original developer.
2. Can generic manufacturers supply Pexidartinib Hydrochloride?
Yes, following patent expiry or through licensing agreements, generic manufacturers can produce and supply Pexidartinib, increasing overall availability.
3. What regions have authorized the distribution of Pexidartinib?
The United States (FDA), Japan (PMDA), and certain European countries (EMA) have approved Pexidartinib, with suppliers aligned to regional regulatory standards.
4. Are there risks associated with supply chain disruptions for Pexidartinib?
Yes, manufacturing capacity constraints, regulatory hurdles, and geopolitical factors pose risks, emphasizing the need for diversified supplier networks.
5. How does patent status affect the supply for Pexidartinib?
Patent protections limit generic manufacturing; once patents expire or are licensed, the number of suppliers typically increases, reducing costs and improving supply resilience.
References
- FDA Approval of Pexidartinib for TGCT, 2019
- Daiichi Sankyo Company Products Portal
- CordenPharma Capabilities & Offerings
- Lonza API Manufacturing Capabilities
- [EMA and NMPA Regulatory Guidelines](https://www.ema.europa.eu/en, https://www.nmpa.gov.cn)
Prepared by: [Your Name], Pharmaceutical Patent and Supply Chain Analyst
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