Bulk Pharmaceutical API Sources for TIGLUTIK KIT

Bulk Pharmaceutical API Sources for TIGLUTIK KIT

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		JoBdDFDhAArErCrFRJJEIYRYPsS@AUT@@@
ChemBlock		ZERO/001785
Sigma-Aldrich		R116_SIGMA
NovoSeek		5070
Alinda Chemical		ALBB-006046

Bulk Active Pharmaceutical Ingredient (API) Sources for: TIGLUTIK KIT

Last updated: August 2, 2025

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Introduction

Tiglutik Kit is a pharmaceutical product indicated for the treatment of amyotrophic lateral sclerosis (ALS), delivering the active pharmaceutical ingredient (API) edaravone in a unique oral suspension. As a critical component of the manufacturing supply chain, sourcing high-quality bulk API—edaravone—is fundamental to ensure consistent drug efficacy, safety, and regulatory compliance. This analysis explores global API sourcing options, highlighting manufacturers, geographic considerations, quality standards, and strategic procurement factors relevant to the production of Tiglutik Kits.

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Overview of Edaravone as an API

Edaravone (chemical name: 3-methyl-1-phenyl-2-pyrazolin-5-one) functions as a free radical scavenger, approved for neuroprotective effects in ALS. Since its initial approval in Japan in 2015 and subsequent approvals in the U.S. and Europe, edaravone’s supply chain has expanded. Its synthesis is complex, involving multi-step chemical processes demanding stringent quality controls. Reliable API sourcing is vital to meet the strict standards of pharmacopeial and regulatory agencies such as the FDA, EMA, and JP (Japanese Pharmacopoeia).

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Global API Suppliers for Edaravone

1. Established Manufacturers

a. Mitsubishi Tanabe Pharma Corporation (Japan)
Mitsubishi Tanabe developed the original commercial formulation of edaravone. They operate their own manufacturing facilities adhering to Good Manufacturing Practices (GMP), ensuring high standards of API production. For global partnerships, Mitsubishi’s API is often preferred due to its proven efficacy and regulatory acceptance.

b. OriGen Pharmaceuticals (United States)
OriGen develops and supplies APIs used in neurological disorders, including edaravone. Their manufacturing processes comply with FDA regulations, emphasizing purity, consistency, and supply reliability.

c. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui has expanded into the neurological APIs market, including edaravone, following approval in China. They possess GMP-certified facilities, offering competitive pricing and scalable supply channels.

d. Adooq Bioscience (United States)
Specializing in research-grade APIs, Adooq offers edaravone for early development and clinical trials. While they may not serve large-scale commercial needs, they can be strategic for pilot phases and expanding supplier networks.

2. Emerging and Contract Manufacturing Organizations (CMOs)

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A CMO with GMP certification, Hisun offers large-scale production and has received regulatory acceptance in multiple jurisdictions.

b. Thermo Fisher Scientific (Global)
Provides custom API manufacturing services, including edaravone, meeting high regulatory standards globally. Their extensive capacity enables supply continuity for large-scale production.

c. WuXi AppTec (China/Global)
As an integrated R&D and manufacturing services provider, WuXi offers API synthesis and scale-up with stringent quality oversight, suitable for global pharmaceutical companies.

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Key Considerations in API Sourcing

• Regulatory Compliance: Ensuring API suppliers hold current GMP certifications aligned with regional regulatory standards (FDA, EMA, PMDA).
• Quality Assurance: Vendors must provide comprehensive analytical data, stability profiles, and batch consistency documentation conforming to Ph. Eur., USP, or JP monographs.
• Supply Reliability: Long-term agreements with validated suppliers mitigate supply chain disruptions, considering geopolitical factors, capacity, and geopolitical risks, especially from China and India.
• Pricing and Capacity: Competitive pricing in tandem with scalable manufacturing capacity is essential, particularly amid global supply constraints.

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Strategic Sourcing Approaches

• Dual sourcing: Engaging two suppliers from different geographic regions ensures supply security and mitigates risk.
• Vertical integration: Partnering with manufacturers involved in downstream quality control reduces variability and enhances oversight.
• Supplier audits: Conducting thorough GMP and site audits ensures adherence to quality standards before committing long-term contracts.

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Regulatory and Quality Considerations

API sourcing for Tiglutik must align with regulatory agencies’ stringent standards. A detailed dossier, including site validation, process validation, impurity profiles, and stability data, must be maintained. For API imported into the U.S., compliance with the Drug Master File (DMF) process via the FDA is crucial. Similarly, European manufacturers must align with CEP or UK-CA documentation to facilitate market access.

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OEM and Contract Manufacturing Contracts

Manufacturers of Tiglutik kits often rely on Original Equipment Manufacturers (OEMs) and CMOs for API sourcing. Strategic partnerships with approved vendors minimize changes to formulation and reduce regulatory submission burdens. Securing contracts with multiple GMP-certified API suppliers ensures flexibility with procurement and regulatory approval pathways.

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Future Trends and Innovations

As the ALS market expands, advances in synthetic pathways, including greener chemistry approaches, may influence future API sourcing strategies. Additionally, with increasing global attention on supply chain resilience, diversification of API sources is expected to remain a priority.

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Conclusion

Sourcing bulk API for Tiglutik kit necessitates a multi-faceted approach emphasizing regulatory compliance, quality assurance, supply stability, and strategic partnerships. Established manufacturers like Mitsubishi Tanabe and Hengrui remain primary options, complementing emerging CMOs and global contract manufacturers. Sourcing strategies must adapt to geopolitical trends, supply chain disruptions, and evolving regulatory standards to ensure consistent, safe, and cost-effective supply of edaravone for inclusion in Tiglutik kits.

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Key Takeaways

• Prioritize GMP-certified suppliers with proven track records and regulatory acceptance relevant to targeted markets.
• Diversify sources across geographic regions to reduce dependency on single suppliers or regions, especially considering geopolitical risks.
• Implement rigorous quality controls and regular audits to ensure API batch-to-batch consistency, critical for therapeutic efficacy.
• Engage in long-term supply agreements to safeguard capacity and pricing stability amid fluctuating global supply chains.
• Monitor technological developments in API synthesis to capitalize on more sustainable, efficient manufacturing processes that could reduce costs or improve yields.

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FAQs

1. What are the primary challenges in sourcing edaravone API globally?
Supply chain disruptions due to geopolitical tensions, regulatory variations across regions, quality assurance complexities, and fluctuating manufacturing costs pose primary challenges.

2. How does regulatory compliance influence API sourcing decisions?
Regulatory acceptance, such as GMP certification and documentation like DMFs or CEPs, assures quality, facilitates approval processes, and mitigates compliance risks.

3. Are Chinese API manufacturers a reliable option for edaravone supply?
Yes, many Chinese manufacturers hold GMP certifications and serve global markets, but thorough audits and regulatory evaluations are recommended to ensure robustness.

4. Can emerging manufacturers match the quality standards of established firms?
Emerging manufacturers investing in GMP-certified facilities and process validation can match quality standards, but due diligence and qualification processes are essential.

5. How does API quality impact the final Tiglutik product?
API quality directly affects the safety, efficacy, and regulatory approval of Tiglutik. Variability in API purity or stability compromises product consistency and patient safety.

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References

1. [1] Mitsubishi Tanabe Pharma Corporation. Edaravone (Radicava) API Quality Information.
2. [2] U.S. FDA Drug Master File Database.
3. [3] European Medicines Agency. API manufacturing guidelines.
4. [4] Jiangsu Hengrui Medicine Co., Ltd. API manufacturing capabilities.
5. [5] WuXi AppTec. Contract API manufacturing services overview.