Suppliers and packagers for radicava

radicava

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mitsubishi Tanabe	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176	NDA	Mitsubishi Tanabe Pharma America, Inc.	70510-2171-2	2 BAG in 1 CARTON (70510-2171-2) / 100 mL in 1 BAG (70510-2171-1)	2017-05-05

Suppliers for the Pharmaceutical Drug: RADICAVA (Edaravone)

Last updated: August 3, 2025

Introduction

Radicava (edaravone) is a neuroprotective agent primarily prescribed for the treatment of amyotrophic lateral sclerosis (ALS). Since its approval, the drug has gained prominence within neurology-focused pharmaceutical markets. Securing reliable suppliers for Radicava involves understanding its manufacturing landscape, regulatory status, and supply chain intricacies. This article provides a comprehensive overview of key suppliers, manufacturing considerations, and strategic insights relevant to stakeholders in need of Radicava sourcing.

Manufacturers and Supply Chain Overview

Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma, headquartered in Japan, is the original developer of edaravone. The company maintains extensive manufacturing facilities dedicated to the synthesis, formulation, and packaging of Radicava. As the sole patent-holder in many jurisdictions, Mitsubishi Tanabe’s role as the primary supplier is pivotal, especially given its regulatory approvals in regions such as Japan, the U.S., and Europe.

The company’s manufacturing processes adhere to Good Manufacturing Practices (GMP), ensuring product quality and consistency. Mitsubishi Tanabe collaborates with licensing partners to expand access in various markets but remains the central source for bulk production and distribution rights.

Other Potential Suppliers and Licensing Arrangements

Licensing and Partnerships

While Mitsubishi Tanabe Pharma remains the dominant supplier, strategic licensing agreements influence the global supply landscape. It is common for regional pharmaceutical companies to license edaravone manufacturing rights, which can diversify supply sources.

In regions such as South Korea, certain local manufacturers have obtained approval to produce edaravone under license from Mitsubishi Tanabe or subsidiaries. For example, Hanmi Pharmaceutical has entered into licensing arrangements to commercialize edaravone, increasing regional supply options.

Generic Manufacturers

The expiration of patents in various jurisdictions opens pathways for generics production, potentially leading to new suppliers entering the market. These manufacturers can obtain approvals through abbreviated regulatory pathways such as the FDA's ANDA (Abbreviated New Drug Application) process, contingent on demonstrating bioequivalence and manufacturing compliance.

Currently, generic edaravone products are limited but expected to expand as patent protections lapse or are challenged.

Regulatory Status and Market Approvals

United States

Radicava (edaravone) received FDA approval in 2017, with the agency certifying the specific formulation supplied by Mitsubishi Tanabe Pharma. The approval process required compliance with stringent cGMP standards, with the supply chain limited primarily to Mitsubishi Tanabe and licensed partners.

Europe and Other Markets

Regulatory approval in Europe and other regions varies, with approval often contingent on local regulatory submissions and licensing agreements. Manufacturers must demonstrate conformity with regional quality standards, impacting supplier choices.

Supply Chain Challenges and Considerations

• Manufacturing Capacity: Limited manufacturing facilities by Mitsubishi Tanabe constrain global supply, especially during increased demand or pandemic-related disruptions.

• Regulatory Hurdles: New entrants, such as generic manufacturers, need to navigate complex approval processes, which can delay new suppliers entering the market.

• Pricing and Procurement Policies: Pricing negotiations and reimbursement policies influence procurement strategies.

• Supply Chain Security: Given the critical nature of ALS treatments, stakeholders prioritize suppliers with proven compliance, robust quality assurance protocols, and reliable delivery histories.

Future Outlook and Strategic Insights

• Emergence of Generics: As patent protections expire, expect increased entry of generic edaravone manufacturers, expanding supply options and potentially driving down prices.

• Manufacturing Capacity Expansion: Mitsubishi Tanabe and licensed partners are likely to invest in expanding production capacity to meet global demand.

• Regional Licensing Agreements: Additional licensing deals can augment regional supply stability, especially in emerging markets.

• Supply Chain Diversification: Healthcare providers and pharmaceutical companies should consider diversified sourcing to mitigate risks associated with regulatory delays or manufacturing disruptions.

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Key Takeaways

• Mitsubishi Tanabe Pharma remains the primary supplier of Radicava (edaravone), with exclusive manufacturing rights in many markets.
• Licensing agreements and regional partnerships expand the supplier network but are initially limited; generic manufacturers are poised to enter as patents expire.
• Supply chain reliability hinges on manufacturing capacity, regulatory approvals, and quality compliance.
• Stakeholders should monitor patent developments and licensing negotiations for strategic sourcing opportunities.
• Diversification and proactive capacity planning are essential to ensuring continuous supply and cost management for Radicava.

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Frequently Asked Questions (FAQs)

1. Who are the main manufacturers of Radicava (edaravone)?
Mitsubishi Tanabe Pharma is the original manufacturer and primary supplier globally. Licensed regional manufacturers and emerging generic producers may also supply edaravone as patents expire.

2. Are there generic versions of Radicava available?
Generic edaravone products are limited but expected to increase as patent protections expire and more manufacturers obtain regulatory approval.

3. How does patent expiration impact supplier options for Radicava?
Patent expiration facilitates entry of generic manufacturers, expanding supply options, reducing costs, and increasing regional availability.

4. What regulatory considerations affect supplier selection?
Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), obtain necessary approvals from agencies such as the FDA, EMA, or local agencies, and meet regional quality standards.

5. What supply chain risks should stakeholders anticipate?
Risks include manufacturing capacity constraints, regulatory delays, geopolitical factors, and disruptions due to global events like pandemics. Diversifying suppliers and monitoring regulatory developments mitigate these risks.

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References

[1] Mitsubishi Tanabe Pharma Corporation. (2023). Radicava (edaravone) Product Information.
[2] U.S. Food and Drug Administration. (2017). FDA approves edaravone for ALS.
[3] European Medicines Agency. (2022). Regulatory status of edaravone in Europe.
[4] GlobalData. (2023). Analysis of edaravone supply chain and market outlook.