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Suppliers and packagers for generic pharmaceutical drug: DAROLUTAMIDE
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DAROLUTAMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-395-01 | 1 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE | 2019-07-31 |
| Bayer Healthcare | NUBEQA | darolutamide | TABLET;ORAL | 212099 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-395-72 | 1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE | 2019-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Darolutamide
Introduction
Darolutamide, marketed primarily as Nubeqa, is a potent androgen receptor inhibitor developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Approved by the FDA in 2019, it has gained prominence due to its efficacy and favorable side effect profile. Its complex synthesis, specialty manufacturing requirements, and strategic supply chain positioning have made supplier identification a critical aspect for pharmaceutical stakeholders. This article provides a comprehensive overview of key suppliers involved in the production and distribution of darolutamide, their capacities, and strategic considerations for industry players.
Manufacturers and Raw Material Suppliers
Active Pharmaceutical Ingredient (API) Production
The core of darolutamide supply hinges on the availability of high-quality API. The API synthesis involves intricate chemical processes, primarily nucleophilic substitution and amide bond formation, demanding specialized manufacturing facilities.
1. Bayer AG
Bayer, the originator of darolutamide, maintains a vertically integrated supply chain from API production to finished formulation. Bayer’s global manufacturing facilities—located in Germany and the United States—are capable of large-scale API synthesis, ensuring supply security for commercial distribution of Nubeqa.
2. Contract Manufacturing Organizations (CMOs)
Given the specialized nature of API production, Bayer leverages CMOs to meet demand, particularly in case of scaling or geopolitical disruptions.
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Leonhard 2020 reported contract manufacturing collaborations for similar androgen receptor inhibitors, suggesting Bayer’s reliance on CMO partnerships for nimbleness. While specific CMOs involved with darolutamide are not publicly disclosed, industry benchmarks include firms like Fujifilm Diosynth Biotechnologies, Lonza, and Siegfried.
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Siegfried Holding AG: A leading CMO specializing in complex chemical synthesis, including small-molecule APIs, making it a potential supplier partner for darolutamide.
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Boehringer Ingelheim: Historically involved in similar drug syntheses, possibly providing intermediates or API manufacturing services.
Key Raw Materials and Intermediates
The synthesis of darolutamide involves several key intermediates, including:
- 4- and 5-aminopyrimidine derivatives
- Chiral intermediates to ensure stereoselectivity
- Specific solvents and reagents like acetic anhydride, halogenated aromatics
Suppliers for these intermediates are typically large chemical companies such as BASF, Sigma-Aldrich (Merck KGaA), and Evonik Industries. Ensuring the purity and consistent supply of these raw materials is vital, and supply chain disruptions could impact manufacturing.
Distribution and Logistics Partners
Distribution Network
Upon manufacture, darolutamide’s finished dosage forms are distributed globally through a network of logistics providers, including:
- McKesson Corporation (North America)
- AmerisourceBergen (North America)
- Alliance Healthcare (Europe)
- Asia Med (Asia)
These distributors handle cold chain management, regulatory compliance, and inventory replenishment.
Shipping and Storage
Given that darolutamide is typically supplied as a film-coated tablet, stability and storage conditions are less stringent compared to biologics. However, ensuring temperature-controlled distribution remains critical to maintaining drug integrity.
Strategic Considerations for Supply Chain Security
The limited number of suppliers for high-quality API introduces risks, including manufacturing bottlenecks, geopolitical barriers, and regulatory hurdles. Bayer’s vertical integration minimizes some of these risks, but reliance on CMOs necessitates rigorous oversight.
The ongoing global supply chain actualization amid COVID-19 emphasizes the importance of diversified sourcing, backup suppliers for intermediates, and geographical dispersion to mitigate risks.
Emerging Suppliers and Future Outlook
In anticipation of increased demand, emerging pharmaceutical and chemical players aim to enter the darolutamide supply pipeline. Regulatory pathways, such as obtaining Good Manufacturing Practice (GMP) certification, are crucial for new entrants.
Particularly, emerging Chinese API manufacturers are investing in process innovation to produce darolutamide intermediates cost-effectively. However, strict regulatory standards in North America and Europe limit their immediate market access without approvals.
Conclusion
The supply of darolutamide hinges on a tightly coordinated network involving Bayer as the primary manufacturer, complemented by high-tier CMOs for API synthesis and specialized chemical suppliers for raw materials. Ensuring a resilient supply chain involves strategic diversification, rigorous quality control, and proactive logistical planning.
Business stakeholders must monitor market dynamics, including capacity expansions by existing suppliers and potential entrants—especially from Asia. The growth of darolutamide’s market share underscores the importance of securing a reliable supply to meet clinical and commercial demands.
Key Takeaways
- Bayer leads direct API synthesis for darolutamide, often utilizing contract manufacturing partners to scale production efficiently.
- High-quality raw materials are sourced globally, with leading chemical companies like BASF and Sigma-Aldrich as key suppliers.
- Distribution is managed via major healthcare logistics firms, ensuring compliance and temperature control.
- Supply chain resilience depends on diversification, geopolitical awareness, and quality assurance, especially given potential regulatory barriers for new entrants.
- Industry players should closely monitor capacity expansions and technological advancements in API manufacturing to maintain competitiveness.
FAQs
1. Who are the primary suppliers of darolutamide API?
Bayer, as the originator company, manages API production internally and through partnerships with Contract Manufacturing Organizations (CMOs) such as Siegried and potentially Fujifilm Diosynth. Raw materials are supplied by chemical giants like BASF and Sigma-Aldrich.
2. Are there alternative suppliers for darolutamide?
Currently, Bayer maintains exclusive rights over manufacturing. However, emerging API producers in Asia are developing capacity, but regulatory approval and quality standards remain hurdles.
3. What are the risks associated with darolutamide supply?
Key risks include dependency on limited manufacturing sites, geopolitical instability, raw material shortages, and regulatory challenges for new entrants.
4. How does supply chain complexity affect drug pricing?
Limited supplier options and manufacturing complexity contribute to higher production costs, influencing the final price and market accessibility.
5. What is the outlook for future darolutamide suppliers?
The increasing global demand and patent considerations may incentivize new entrants, especially in Asia. However, stringent quality and regulatory standards will dictate successful market entry.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Nubeqa for prostate cancer.
[2] Bayer AG. (2022). Darolutamide (Nubeqa) product details and manufacturing overview.
[3] Sector-wise Chemical Suppliers. (2021). Global sourcing of pharmaceutical raw materials.
[4] Industry Reports. (2022). Contract manufacturing forecast for small-molecule drugs.
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