Bulk Pharmaceutical API Sources for ELIGLUSTAT TARTRATE

Bulk Pharmaceutical API Sources for ELIGLUSTAT TARTRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-14885A
AbaChemScene		CS-5423
AbovChem LLC		HY-14885A
DC Chemicals		DC9291
MuseChem		I005521

Bulk Active Pharmaceutical Ingredient (API) Sources for ELIGLUSTAT TARTRATE

Last updated: July 28, 2025

Introduction

Eliglustat tartrate, marketed as Cerdelga, is an oral substrate reduction therapy (SRT) indicated for the treatment of Gaucher disease type 1. As a selective inhibitor of glucosylceramide synthase, eliglustat reduces the accumulation of glucocerebroside within lysosomes, mitigating disease symptoms. The quality and sourcing of the active pharmaceutical ingredient (API) are critical for manufacturing efficacy, safety, and regulatory compliance. This report explores the global landscape of API manufacturers supplying eliglustat tartrate, highlighting key sourcing options, manufacturing capabilities, and strategic considerations for pharmaceutical companies.

API Manufacturing Landscape for Eliglustat Tartrate

The manufacturing of eliglustat tartrate involves complex chemical synthesis processes that require high purity, strict regulatory compliance, and robust quality control. Several API producers worldwide have emerged as credible sources, either through direct manufacturing partnerships or through outsourcing agreements.

1. Leading API Suppliers

a. Boehringer Ingelheim

• Overview: Boehringer Ingelheim, a global pharmaceutical leader based in Germany, has a strong portfolio in rare disease treatments, including Gaucher disease therapies. The company advances its API manufacturing capabilities for eliglustat tartrate at its North American and European facilities.

• Manufacturing Capabilities: Boehringer employs state-of-the-art synthetic chemistry processes, complying with cGMP standards. Their facilities feature extensive analytical testing, ensuring impurities are minimized and product quality is maintained.

• Regulatory Status: As the original developer of eliglustat, Boehringer Ingelheim holds Marketing Authorization (MA) in multiple regions and supplies API under strict regulatory oversight.

b. Thermo Fisher Scientific

• Overview: Thermo Fisher Scientific is a leading contract manufacturing organization (CMO) with extensive capabilities in API synthesis and purification.

• API Supply: Thermo Fisher offers custom synthesis of eliglustat tartrate for clinical trial batches and commercial production. Their manufacturing infrastructure supports large-scale production with high quality standards.

• Quality Assurance: Thermo Fisher adheres to cGMP regulations, providing validated processes and comprehensive documentation suitable for global regulatory approval.

c. WuXi AppTec

• Overview: WuXi AppTec is a notable Chinese CMO offering comprehensive API development and manufacturing services.

• Capabilities: WuXi possesses robust synthetic chemistry platform capabilities, including scale-up synthesis of complex molecules like eliglustat tartrate, with a focus on cost-effectiveness and regulatory compliance.

• Supply Security: Their global supply chain network ensures reliable production, supporting both early-stage and commercial requirements.

d. Cambrex Corporation

• Overview: Cambrex, headquartered in the United States, specializes in manufacturing active pharmaceutical ingredients and advanced intermediates.

• API Production: Cambrex has capabilities in complex syntheses, including chiral intermediates; manufacturing eliglustat tartrate aligns with their expertise in high-purity APIs.

2. Emerging and Academic Suppliers

While primarily operating on a smaller scale, several academic institutions and specialized chemical synthesis firms are developing innovative routes for eliglustat API, potentially offering flexible sourcing options, particularly during early clinical phases or for specific markets.

3. Criteria for API Sourcing

When selecting a supplier for eliglustat tartrate API, pharmaceutical manufacturers consider multiple factors:

• Regulatory Compliance: GMP certification, audit histories, and documented quality systems.

• Manufacturing Capacity: Ability to meet demand volume and supply chain stability.

• Chemical Purity and Impurity Profile: Validation in analytical testing to ensure batch-to-batch consistency.

• Cost and Lead Times: Competitive pricing and reliable delivery schedules.

• Intellectual Property (IP): Licensing or rights associated with proprietary synthetic routes.

4. Regulatory and Certification Considerations

For API procurement, compliance with regulatory standards such as FDA, EMA, and China’s NMPA is essential. Suppliers should provide comprehensive documentation, including Certificates of Analysis (CoA), Certificates of Suitability (CEP), and Drug Master Files (DMF).

5. Outsourcing and Licensing Trends

Contract manufacturing organizations and licensing arrangements enable rapid scaling and flexibility. Many originators and developers opt to outsource API synthesis to reduce costs, access expertise, and ensure supply chain resilience.

Strategic Insights for Pharmaceutical Companies

• Agility in Supply Chain: Diversify API sourcing to mitigate risks associated with geopolitical issues, manufacturing delays, or supply shortages.

• Due Diligence: Conduct rigorous assessments of supplier quality systems, capacity, and compliance records before securing supply agreements.

• Long-Term Partnerships: Establish strategic alliances with trusted OEMs or CMOs for continuity and ongoing technological support.

• Regulatory Preparedness: Ensure all API sources can support submissions for regulatory approval, including complying with regional pharmacopoeias.

Key Takeaways

• Multiple global suppliers, including Boehringer Ingelheim, Thermo Fisher Scientific, WuXi AppTec, and Cambrex, supply eliglustat tartrate API, each with varying specialties and capacities.

• Regulatory compliance, manufacturing capacity, and quality assurance are critical considerations when sourcing API.

• Outsourcing to experienced CMOs offers advantages in cost, scalability, and flexibility, especially for clinical and commercial production.

• Suppliers with proven regulatory track records and transparent quality systems are preferable for ensuring uninterrupted supply and compliance.

• Diversification of sourcing mitigates risks and optimizes supply chain resilience for eliglustat tartrate production.

FAQs

1. What are the primary factors to consider when sourcing eliglustat tartrate API?
Regulatory compliance (GMP certification), manufacturing capacity, chemical purity, impurity profile, lead times, cost, and supplier reputation are crucial factors.

2. Which companies are the most reputable sources for eliglustat tartrate API?
Boehringer Ingelheim remains the original developer and a trustworthy source. Other reputable suppliers include Thermo Fisher Scientific, WuXi AppTec, and Cambrex.

3. Are there alternative sourcing options for eliglustat tartrate API in emerging markets?
Yes, several Chinese and Indian CMOs like WuXi and others are increasingly involved in complex API synthesis, providing competitive options with capable regulatory oversight.

4. How does regulatory compliance influence API sourcing decisions?
Regulatory compliance ensures legal authorization for manufacturing and marketing. Suppliers must provide necessary certifications, documentation, and compliance history to facilitate smooth regulatory submissions.

5. What risks are associated with API supply chain disruptions?
Risks include supply shortages, quality inconsistencies, geopolitical issues, and regulatory setbacks. Diversification and rigorous supplier assessments mitigate these risks.

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References

1. [1] Boehringer Ingelheim official website. (Accessed 2023)
2. [2] Thermo Fisher Scientific. API manufacturing services. (2023)
3. [3] WuXi AppTec capabilities overview. (2023)
4. [4] Cambrex Corporation API portfolio. (2023)
5. [5] Regulatory standards and compliance guidelines. U.S. FDA, EMA, NMPA.