Bulk Pharmaceutical API Sources for OZANIMOD HYDROCHLORIDE

Bulk Pharmaceutical API Sources for OZANIMOD HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
BLD Pharm		BD01287389
Apexmol		AMY27884
DC Chemicals		DC59005

Bulk Active Pharmaceutical Ingredient (API) Sources for Ozanimod Hydrochloride

Last updated: August 4, 2025

Introduction

Ozanimod hydrochloride is a selective sphingosine-1-phosphate receptor modulator primarily indicated for multiple sclerosis (MS) and ulcerative colitis. As a groundbreaking therapeutic agent, its manufacturing and sourcing of bulk Active Pharmaceutical Ingredient (API) are pivotal to ensure consistent supply, regulatory compliance, and cost efficiency. This report provides an in-depth overview of current API sourcing strategies, key players, and considerations vital for pharmaceutical companies seeking reliable API suppliers for ozanimod hydrochloride.

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Overview of Ozanimod Hydrochloride API Sourcing

The sourcing landscape for ozanimod hydrochloride API is characterized by a limited pool of specialized manufacturers capable of producing complex S1P receptor modulators. Given its unique chemical structure and synthesis complexities, pharmaceutical companies depend on select API suppliers with proven expertise in heterocyclic chemistry, high-potency drug substances, and stringent quality control.

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Manufacturers and Key API Suppliers

1. Biotech and Contract Manufacturing Organizations (CMOs)

Most API production for ozanimod hydrochloride occurs through Contract Manufacturing Organizations (CMOs) with advanced chemical synthesis capabilities, often operating under strict confidentiality and regulatory standards.

• AbbVie
  As the originator of ozanimod (marketed as Zeposia®), AbbVie maintains internal API manufacturing facilities and collaborates with external APIs suppliers for global distribution. The company likely owns or closely partners with specialized CMOs to secure a reliable supply chain, given their comprehensive involvement in ozanimod development.

• WuXi STA
  Known for scalable synthesis of complex APIs, WuXi STA offers contract manufacturing of S1P receptor modulators, including ozanimod. Their expertise spans multi-step synthesis and regulatory-compliant production, making them a key external supplier option.

• Thermo Fisher Scientific
  This global pharma service provider offers custom synthesis, including APIs with complex heterocyclic structures. While primarily a CDMO, Thermo Fisher supports large-volume API production necessary for commercial supply.

• Samsung Biologics and LG Chem
  While primarily focused on biologics, these firms have expanding capabilities in small molecule synthesis, potentially entering the API market for compounds like ozanimod.

2. Specialized Chemical Synthesizers

Few chemical synthesis companies focus exclusively on the production of S1P receptor modulators, due to the intricacy of their chemical structures.

• Recipharm
  An established provider capable of complex chemical synthesis, Recipharm could be an alternative supplier, especially for large-scale API manufacturing.

• CordenPharma
  Known for complex API production, CordenPharma offers integrated synthesis and purification services pertinent for ozanimod hydrochloride’s intricate chemical structure.

3. Potential Alternative and Developing Suppliers

While the first tier primarily comprises large, well-established CMOs, emerging manufacturers in Asia-Pacific regions are increasingly investing in complex API synthesis capabilities, including:

• Hainan Kangda Pharmaceutical (China)
• Zhejiang Huahai Pharmaceutical (China)
• Sun Pharmaceutical (India)

These companies are expanding their portfolios into specialty APIs, including S1P receptor modulators. However, thorough vetting for quality standards and regulatory compliance is essential due to varying manufacturing standards.

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Sourcing Considerations

Regulatory Compliance and Quality Control
API titans and emerging suppliers must adhere to Good Manufacturing Practices (GMP) to meet regulatory requirements from agencies like FDA, EMA, and PMDA. Certification levels and audit histories influence supplier reliability.

Manufacturing Capacity and Lead Time
Given ozanimod’s complex synthesis, capacity constraints can affect supply continuity. Companies should prioritize long-term relationships with manufacturers possessing scalable processes.

Intellectual Property (IP) and Confidentiality
With patent protections on ozanimod, original manufacturers like AbbVie minimize licensing complexities, but licensing arrangements with third-party suppliers are common.

Cost and Logistics
Market price fluctuations are influenced by raw material costs, synthesis complexity, and regional manufacturing expenses. Geographical considerations—such as proximity to markets—impact logistics and inventory management.

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Emerging Trends and Industry Outlook

The API sourcing for ozanimod hydrochloride aligns with broader industry trends favoring contract manufacturing, supply chain resilience, and technological advancements like continuous manufacturing. The increasing demand for pipeline drugs and complex S1P receptor modulators may drive new entrants into the API supply chain, potentially lowering costs and improving supply security.

Summary

• Top-tier API suppliers include AbbVie’s internal facilities, WuXi STA, Thermo Fisher Scientific, and CordenPharma.
• Emerging manufacturers in China and India are expanding capabilities but require rigorous validation.
• Supply chain reliability hinges upon compliance with GMP standards, capacity, and regulatory record.
• Future trends suggest diversification, regionalization, and technological innovation in API synthesis, promising enhanced stability and reduced costs.

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Key Takeaways

• Partner with established CMOs like WuXi STA and CordenPharma for assured quality and capacity.
• Conduct thorough due diligence on emerging suppliers to mitigate regulatory and quality risks.
• Maintain flexible sourcing strategies to navigate supply disruptions and optimize costs.
• Invest in supplier audits and certification reviews to ensure compliance with international standards.
• Anticipate industry shifts toward innovative manufacturing methods that could streamline API production for complex molecules like ozanimod hydrochloride.

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FAQs

1. Who are the leading API manufacturers for ozanimod hydrochloride?
AbbVie internally produces ozanimod API, and trusted CMOs such as WuXi STA, CordenPharma, and Thermo Fisher Scientific serve as external suppliers, given their capabilities in complex chemical synthesis and GMP compliance.

2. What factors should a pharmaceutical company consider when selecting an API supplier?
Key considerations include regulatory compliance (GMP), manufacturing capacity, technical expertise in complex synthesis, quality control protocols, supply stability, and cost efficiency.

3. Are there alternative sourcing regions for ozanimod API?
Yes, besides North America and Europe, Asian countries—particularly China and India—are developing capabilities, offering potentially lower costs but necessitating thorough validation for quality and regulatory adherence.

4. How does intellectual property influence API sourcing for ozanimod?
Patent protections restrict licensing and manufacturing rights. Companies often partner with original developers or authorized CMOs, ensuring regulatory and IP compliance.

5. What future developments could impact ozanimod API sourcing?
Advances in continuous manufacturing, process simplification, and regional capacity expansion are expected to improve supply chain resilience and reduce costs in the near future.

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References

1. Zeposia (ozanimod) Prescribing Information, AbbVie, 2022.
2. WuXi STA Capabilities, WuXi Biologics, 2023.
3. CordenPharma API Portfolio, CordenPharma, 2022.
4. Industry Reports on Specialty API Manufacturing, IQVIA, 2023.
5. Regulatory Guidelines for API Manufacturing, FDA, EMA, 2022.