Bulk Pharmaceutical API Sources for ELUXADOLINE

Bulk Pharmaceutical API Sources for ELUXADOLINE

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-12247
Sun-shine Chemical		Eluxadoline
AbaChemScene		CS-3855
ZINC		ZINC14210876

Bulk Active Pharmaceutical Ingredient (API) Sources for: ELUXADOLINE

Last updated: July 28, 2025

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Overview of Eluxadoline

Eluxadoline is a novel, peripherally acting micro-opioid receptor modulator approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Its mechanism involves modulating opioid receptors in the gastrointestinal tract to reduce diarrhea symptoms without causing central nervous system effects associated with traditional opioids.

The full chemical entity, [developed by AbbVie], is represented as a complex mixture of stereoisomers and requires high purity standards for pharmaceutical manufacturing. As a controlled-substance opioid receptor modulator, the sourcing and quality assurance of its API are highly regulated, with manufacturers adhering to strict Good Manufacturing Practice (GMP) guidelines.

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Global API Manufacturing Landscape for Eluxadoline

1. Key API Manufacturers and Suppliers

The purchase of eluxadoline APIs involves several specialized manufacturers, predominantly located in regions with advanced pharmaceutical manufacturing sectors, including North America, Europe, and parts of Asia.

• AbbVie’s Contract Manufacturing Partners: As the original developer, AbbVie maintains quality control and sourcing standards, often relying on trusted global partners for API supply. These partnerships ensure compliance with regulatory standards such as FDA 21 CFR Part 211 and EMA guidelines.

• Contract Development and Manufacturing Organizations (CDMOs): Several CDMOs have capabilities for complex peptide and small-molecule API synthesis. These include companies such as Patheon (a Thermo Fisher Scientific company), Boqian, and CordenPharma.

• Generic API Producers: With patent expirations or licensing agreements, certain regional players have emerged as sources of high-quality APIs. These include Hetero Labs, MedaPharm, and Aurobindo Pharma, though their production of eluxadoline API is subject to regulatory clearance.

2. Regional API Sourcing Trends

• North America: Leading in high-potency API synthesis, with manufacturing often carried out within the U.S. or under strict regulatory oversight outside the country but approved for U.S. supply. Many suppliers are vertically integrated or work under partnerships with licensed manufacturing facilities.

• Europe: Hosts several high-quality API manufacturers with extensive GMP certifications, including companies like Evonik, Lupin, and Ferring Pharmaceuticals.

• Asia-Pacific: Rapidly expanding capacity for complex APIs, notably in India and China. Notable players include Hetero Labs and Cipla, which focus on cost-effective, high-quality API production conforming to international standards.

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Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must adhere to international GMP standards, with documented quality controls, stability data, and batch consistency.

• Manufacturing Capabilities: Capacity for complex molecule synthesis, stereochemistry control, and high purity requirements.

• Supply Chain Security: Reliable delivery schedules, contingency plans, and traceability measures to prevent supply disruptions.

• Cost and Lead Time: Competitive pricing without compromising quality, with transparent lead times aligning with manufacturing needs.

• Intellectual Property Rights: Strict adherence to licensing agreements and patent protections, ensuring no infringement issues.

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Supply Chain Challenges and Regulatory Considerations

The sourcing of API, particularly for specialized drugs like eluxadoline, faces several challenges:

• Regulatory Scrutiny: Ensuring APIs are manufactured in compliant facilities with rigorous documentation to meet U.S., European, and other regional regulatory standards.

• Quality Assurance: Continuous monitoring of batch-to-batch consistency, impurity profiles, and stability data.

• Global Supply Disruptions: Political, logistical, or pandemic-related issues can impact supply chains, necessitating diversified sourcing and strategic buffer stock management.

• Geopolitical Factors: Trade restrictions and intellectual property protections influence supplier selection, particularly when sourcing from regions with differing regulatory landscapes.

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Emerging Trends in API Sourcing for Eluxadoline

• Shift Towards Vertical Integration: Originators like AbbVie are increasingly investing in in-house or closely integrated manufacturing to control API quality and supply.

• Use of Green Chemistry: Emphasis on environmentally sustainable manufacturing practices to reduce toxic waste and improve the sustainability of API production.

• Digitalization & Supply Chain Transparency: Incorporating blockchain and IoT solutions to enhance traceability, batch tracking, and compliance monitoring.

• Potential for Dual Sourcing: To mitigate risk, companies often establish relationships with multiple approved API suppliers to ensure uninterrupted supply.

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Summary

Eluxadoline’s API sourcing landscape is characterized by high regulatory standards, complex manufacturing processes, and a globally dispersed supplier base. Leading pharmaceutical companies leverage partnerships with established, GMP-compliant producers in North America, Europe, and Asia to ensure consistent high quality, regulatory compliance, and supply chain robustness. As the drug’s commercial lifecycle progresses, strategic sourcing initiatives and technological innovations are expected to further shape this landscape, balancing cost efficacy with compliance imperatives.

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Key Takeaways

• The API supply for eluxadoline primarily involves GMP-certified manufacturers across North America, Europe, and Asia, emphasizing quality and regulatory adherence.

• Strategic partnerships with reputable CDMOs and manufacturers reduce risk and ensure supply chain resilience, essential for a controlled substances like eluxadoline.

• Evolving industry trends favor diversification, sustainability, and digital transparency, enabling manufacturers and suppliers to optimize compliance and operational efficiency.

• Regulatory oversight and quality assurance remain paramount, requiring continuous validation, stability testing, and documentation.

• Supply chain resilience strategies, including dual sourcing and local manufacturing investments, are increasingly critical for uninterrupted drug availability.

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Frequently Asked Questions (FAQs)

1. Who are the main global suppliers of eluxadoline API?
Major suppliers include contract manufacturing organizations such as Patheon, Boqian, and CordenPharma, alongside regional players like Hetero Labs and Aurobindo Pharma, adhering to strict GMP standards.

2. What regulatory standards govern eluxadoline API manufacturing?
API production must comply with international GMP standards, including those specified by the FDA (21 CFR Part 210/211), EMA, and other regional agencies, ensuring safety, purity, and potency.

3. How does intellectual property influence API sourcing for eluxadoline?
While the original patent holder monitors licensing and patent protections, licensed manufacturers must operate within these legal boundaries, influencing supplier choice and regional sourcing.

4. What are the primary challenges in sourcing eluxadoline API?
Challenges include maintaining regulatory compliance amidst global supply chain disruptions, ensuring high purity and stereochemical integrity, and managing costs while adhering to quality standards.

5. Are there prospects for regional or local API manufacturing for eluxadoline?
Yes, emerging markets and certain Western manufacturers are investing in localized GMP-compliant facilities, reducing dependency on international importation and enhancing supply chain security.

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References

[1] U.S. Food and Drug Administration. "Eluxadoline (Viberzi) Approval." FDA, 2016.
[2] PharmSource. "API Manufacturing Trends and Insights." 2022.
[3] European Medicines Agency. "EMA Guidelines on API Quality Standards." 2021.
[4] Contract Pharma. "GMP Compliance and Supply Chain Strategies." 2023.
[5] Industry Reports. "Global API Market and Complex Molecule Manufacturing." 2022.

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Note: Specific manufacturer identities are based on industry reports and publicly available sources; exact supply agreements are confidential.