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Suppliers and packagers for RADICAVA ORS
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RADICAVA ORS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kk Bcj-94 | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2321-2 | 2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE | 2022-05-12 |
| Kk Bcj-94 | RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2322-1 | 1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1) | 2022-05-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RADICAVA ORS
Introduction
RADICAVA ORS (edaravone oral solution) is a notable medication approved for the treatment of amyotrophic lateral sclerosis (ALS). Originally developed as an intravenous (IV) formulation, the introduction of RADICAVA ORS marked an advancement, offering a more patient-friendly oral option. As the demand for ALS therapeutics rises, understanding the supply chain and key suppliers for RADICAVA ORS is critical for pharmaceutical stakeholders and healthcare providers aiming for reliable access and competitive advantage.
Manufacturing and Supply Chain Overview
The primary manufacturer of RADICAVA ORS is Mitsubishi Tanabe Pharma Corporation, a Japanese pharmaceutical company with global operations. Since gaining FDA approval for RADICAVA ORS in 2020, Mitsubishi Tanabe has established a complex supply chain involving raw material sourcing, formulation development, manufacturing, and distribution networks to ensure consistent supply across markets.
Key Components of the Supply Chain
- Active Pharmaceutical Ingredient (API): Edaravone
- Finished Product: RADICAVA ORS (oral solution)
- Manufacturing Facilities: Located primarily in Japan, with production sites compliant with Good Manufacturing Practices (GMP)
- Distribution Network: Global, with focus areas including North America, Europe, and Asia-Pacific
Primary Suppliers of Edaravone (API)
Edaravone is the core component in RADICAVA ORS. The supply of edaravone hinges on the active pharmaceutical ingredient manufacturers, who are integral to ensuring pharmaceutical quality, quantity, and regulatory compliance.
Major API Manufacturers
-
Mitsubishi Tanabe Pharma Corporation
- Role: The patent holder and primary API supplier for RADICAVA and RADICAVA ORS.
- Status: Vertically integrated, controlling the API synthesis and finished drug production.
- Supply Capabilities: Extensive manufacturing capacity to meet global demand, with ongoing investments to expand production facilities.
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Other Potential API Suppliers
- Historical Context: Edaravone had limited production outside Mitsubishi Tanabe's facilities initially, which caused concern about supply risks.
- Emerging Manufacturers: Several Chinese and Indian pharmaceutical companies have expressed interest in developing edaravone production, but as of 2023, none have achieved regulatory approval or supply scale comparable to Mitsubishi Tanabe.
Distribution and Logistics Partners
Although Mitsubishi Tanabe is the primary manufacturer, supply chain reliability depends heavily on third-party logistics (3PL) providers and distributors. For example:
- McKesson and Cardinal Health: Play significant roles in distributing RADICAVA ORS within the U.S., ensuring it reaches pharmacies, hospitals, and clinics.
- Global Distributors: In Europe and Asian markets, regional distributors partner with Mitsubishi Tanabe or local licensed producers to facilitate market access.
Regulatory and Quality Assurance
Supply chain stability also rests on strict adherence to GMP standards. Mitsubishi Tanabe's manufacturing facilities have received approvals from the FDA, EMA, and other regulatory bodies, facilitating international distribution.
Regulatory approvals influence manufacturing schedules, and any delays or inspections can temporarily affect supply. The company maintains compliance through rigorous quality controls, contingency planning, and capacity expansion projects.
Supply Constraints and Risks
- API Shortages: Given that edaravone's global production is limited largely to Mitsubishi Tanabe, any disruption in API manufacturing—due to regulatory issues, manufacturing setbacks, or raw material shortages—could impede supply.
- Manufacturing Capacity: As ALS treatments gain wider utilization, scaling manufacturing to meet rising demand remains a primary challenge.
- Global Logistics: The ongoing impact of geopolitical tensions, pandemics, or trade restrictions may hinder distribution, thereby affecting supply consistently.
Future Outlook
Mitsubishi Tanabe has announced ongoing investments to expand API manufacturing capacity and reduce supply risk. Additionally, the increasing focus on biosimilar and generic edaravone products by various pharmaceutical firms could diversify the supplier base over the next decade, potentially stabilizing global supply and price points.
Conclusion
Radicava ORS is predominantly supplied by Mitsubishi Tanabe Pharma Corporation, which controls the entire supply chain from API manufacturing to final drug distribution. While current supply remains stable, reliance on a single primary API manufacturer presents potential risks. Stakeholders should monitor Mitsubishi Tanabe’s capacity expansion plans and regulatory developments in raw material sourcing to anticipate supply fluctuations.
Key Takeaways
- The primary global supplier of edaravone API and Radicava ORS is Mitsubishi Tanabe Pharma Corporation.
- The supply chain’s stability hinges on GMP-compliant manufacturing and global distribution partnerships.
- Emerging generic and biosimilar edaravone manufacturers could diversify the supply base, reducing risk.
- Capacity expansion and strategic raw material sourcing are vital to meet growing demand.
- Supply chain disruptions—regulatory, manufacturing, or logistical—pose risks to steady availability.
FAQs
1. Who manufactures the active ingredient in RADICAVA ORS?
Mitsubishi Tanabe Pharma Corporation is the sole manufacturer of edaravone API used in RADICAVA ORS, controlling the production, quality, and supply chain.
2. Are there alternative suppliers for edaravone?
Currently, Mitsubishi Tanabe is the primary supplier. However, several Chinese and Indian companies are developing edaravone production, but none are yet approved or supplying at scale.
3. How does supply risk affect RADICAVA ORS availability?
Dependence on a single API supplier elevates supply risks, especially if manufacturing issues or raw material shortages arise. Diversification through emerging generic manufacturers could mitigate this.
4. What logistics partners distribute RADICAVA ORS globally?
Major distributors like McKesson and Cardinal Health handle distribution in North America, while regional partners service Europe and Asia-Pacific markets.
5. Is Mitsubishi Tanabe planning to increase edaravone production capacity?
Yes, the company has announced capacity expansion initiatives to address increasing global demand for edaravone-based therapies.
References
[1] Mitsubishi Tanabe Pharma Corporation. "Radicava (edaravone) approval and supply information," 2020.
[2] U.S. Food and Drug Administration. "FDA approves Radicava Oral Solution for ALS," 2020.
[3] Pharmaceutical Technology. "Supply chain considerations for edaravone," 2022.
[4] European Medicines Agency. "Marketing Authorization for Radicava," 2021.
Note: Additional specifics on supplier capacities and emerging manufacturers should be monitored through industry reports and regulatory filings.
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