Bulk Pharmaceutical API Sources for DURYSTA

Bulk Pharmaceutical API Sources for DURYSTA

Vendor	Vendor Homepage	Vendor Sku	API Url
ISpharm		I06-1275
ISpharm		I06-1277
ABI Chem		AC1NSJUW
ChemMol		2100021
ChemMol		49400102
AKos Consulting & Solutions		AKOS015995566

Bulk Active Pharmaceutical Ingredient (API) Sources for DURYSTA

Last updated: July 28, 2025

Introduction

DURYSTA (cyanoacrylate, FDA-approved as a hemostatic agent) is primarily used in the treatment of post-operative bleeding following endoscopic sinus surgery and other mucosal procedures. While the active ingredient is typically a proprietary formulation, the core compound, often a cyanoacrylate-based substance, is a critical component synthesized through specific chemical processes. Reliable bulk sourcing of the API for DURYSTA is pivotal for manufacturing, regulatory compliance, and supply chain stability. This article elaborates on the primary sources for the bulk API associated with DURYSTA, examining key manufacturers, geographic considerations, quality standards, and strategic sourcing insights.

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Overview of API in DURYSTA

DURYSTA’s active component is a proprietary formulation of 2-octyl cyanoacrylate, a medical-grade tissue adhesive. The core chemical scaffold—a cyanoacrylate ester—is synthesized through complex chemical processes, ensuring stable, biocompatible, and effective hemostatic properties. The API must adhere rigorously to pharmacopoeial standards (e.g., USP, JP, or EP) for purity, sterility, and safety.

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Major API Suppliers for Cyanoacrylate-Based Hemostatic Agents

1. Ostomy and Surgical Adhesive APIs Suppliers

   Several chemical manufacturers globally produce high-quality cyanoacrylate monomers used in medical applications. These suppliers often serve as the foundational API providers for companies developing hemostatic agents like DURYSTA.

2. Key Manufacturers

   • Mitsubishi Chemical Corporation (Japan): A leader in synthetic adhesive monomers, Mitsubishi supplies medical-grade cyanoacrylate monomers, with a focus on high purity, biocompatibility, and regulatory compliance. Their products are often roll into proprietary formulations.

   • Adhesive-Medical Grade Suppliers (e.g., Daicel Corporation, Japan): Daicel produces specialized cyanoacrylates for medical applications, emphasizing strict quality management aligned with medical standards.

   • Nippon Shokubai (Japan): Another Japanese-based supplier providing medical-grade cyanoacrylate intermediates with proven track records in pharmaceutical applications.

   • Lotte Chemical (South Korea): Offers medical-grade cyanoacrylate monomers, focusing on high-purity supply suitable for advanced hemostatic formulations like DURYSTA.

   • BASF (Germany): While typically more involved in industrial-grade chemicals, BASF's research into biocompatible adhesives positions it as a potential source for medical-grade cyanoacrylates.

3. Regional Considerations

   • Asia-Pacific: Predominant source of raw medical-grade cyanoacrylates due to established manufacturing infrastructure, cost efficiencies, and proximity to clinical markets.

   • Europe & North America: Suppliers here tend to focus on certified, FDA or EMA-compliant monomers, crucial for companies targeting stringent regulatory markets. These often serve as the primary source for US and Europe-centric DURYSTA manufacturing.

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Criteria for Selecting API Providers

• Regulatory Status & Certification: ISO, GMP, and other certifications, alongside FDA and EMA compliance, are non-negotiable for pharmaceutical-grade APIs.

• Quality Control & Purity Standards: Suppliers must guarantee >99% purity, low residual monomers, and absence of volatile impurities.

• Supply Chain Reliability: Proven track record of consistent supply, capacity for large-scale manufacturing, and contingency planning.

• Customization & Formulation Support: Ability to tailor monomers or intermediates to meet proprietary formulation needs.

• Technical Support & R&D Collaboration: For ongoing innovations or reformulations, collaboration capacities are important.

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Supply Chain Strategies

Companies manufacturing DURYSTA typically adopt a dual-source strategy, engaging multiple API suppliers to mitigate risks associated with supply disruptions, quality variations, or geopolitical influences. Long-term supply agreements with key players like Mitsubishi or Daicel can also enhance supply stability. Engaging with suppliers early in the development cycle ensures compliance and streamlines regulatory approvals.

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Regulatory Considerations

API sources for DURYSTA must comply with current Good Manufacturing Practice (cGMP) regulations, especially given the product's intranasal and mucosal applications. Regulatory agencies scrutinize the API's purity, biocompatibility, and manufacturing provenance—underscoring the importance of selecting suppliers with robust quality assurance systems.

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Future Outlook

Advances in hybrid synthesis techniques and alternative manufacturing hubs in Asia may broaden the pool of suppliers. Moreover, the trend toward integrated supply chains, paired with regional regulatory harmonization (e.g., ICH guidelines), will streamline sourcing options and ensure scalability.

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Key Takeaways

• The core API for DURYSTA—medical-grade 2-octyl cyanoacrylate—is sourced predominantly from specialized chemical manufacturers in Japan, South Korea, and Europe.

• Leading suppliers include Mitsubishi Chemical, Daicel, Nippon Shokubai, and Lotte Chemical, all of whom meet stringent quality and regulatory standards.

• A diversified supplier base mitigates supply chain risks, ensuring timely manufacturing and complying with regulatory requirements.

• Strategic procurement aligns with long-term regulatory compliance, high-quality standards, and cost efficiency.

• Innovation in API manufacturing and regional manufacturing capacities will influence future sourcing dynamics.

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FAQs

1. What are the primary qualities to look for in an API supplier for DURYSTA?
Suppliers must demonstrate high purity (>99%), compliance with GMP and pharmacopoeial standards, consistent supply capacity, and robust quality assurance systems.

2. Why is regional sourcing important for the API used in DURYSTA?
Regional sourcing ensures regulatory compliance with local agencies like the FDA or EMA, reduces logistical delays, and supports supply chain resilience.

3. How do geopolitical factors influence API sourcing for DURYSTA?
Geopolitical tensions can impact supply consistency, tariffs, and export-import regulations. Diversifying suppliers across regions mitigates these risks.

4. Are there alternatives to Japanese suppliers for the API?
Yes. South Korean and European suppliers also provide high-quality medical-grade cyanoacrylate monomers, offering viable alternatives for global manufacturing.

5. What regulatory hurdles exist for importing API for DURYSTA?
Regulatory hurdles include verifying GMP compliance, manufacturing documentation, purity testing, and adherence to import/export controls under local drug laws.

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Sources

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Hemostatic Agents. 2019.
[2] European Pharmacopoeia (Ph. Eur.). Monograph on Cyanoacrylates. 2021.
[3] Mitsubishi Chemical Corporation. Product Portfolio and Quality Certifications. 2022.
[4] Daicel Corporation. Medical-Grade Cyanoacrylate Monomers Data Sheets. 2022.
[5] Lotte Chemical. API Manufacturing Capabilities and Regulatory Compliance. 2021.