Bulk Pharmaceutical API Sources for ELIQUIS

Bulk Pharmaceutical API Sources for ELIQUIS

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS005146204
BioChemPartner		BCPP000396
AbMole Bioscience		1649
BioChemPartner		BCP9000310
MedChemexpress MCE		HY-50667
Amadis Chemical		205688
AbaChemScene		CS-0401

Bulk Active Pharmaceutical Ingredient (API) Sources for Eliquis

Last updated: September 17, 2025

Introduction

Eliquis (apixaban) is a novel oral anticoagulant developed by Bristol-Myers Squibb and Pfizer, primarily used to prevent stroke in patients with non-valvular atrial fibrillation, treat deep vein thrombosis (DVT), and pulmonary embolism (PE). As a highly regulated pharmaceutical, the supply chain for the active pharmaceutical ingredient (API) is critical to ensure high-quality, uninterrupted production, and compliance with international standards. Identifying reliable, quality-controlled API sources for Eliquis involves understanding the complexities of API manufacturing, global supplier landscapes, and regulatory considerations.

Overview of Apixaban API Production

Apixaban is a complex molecule, characterized by a specific chemical synthesis process that demands high purity and stringent quality controls. It belongs to the class of Factor Xa inhibitors and necessitates advanced synthetic chemistry involving multiple steps, including:

• Formation of the core scaffold
• Introduction of chiral centers
• Final purification techniques ensuring API purity above 99%

The production process must adhere to Good Manufacturing Practice (GMP) standards, with rigorous in-process and finished product testing.

Global API Manufacturing Sources

The supply chain for Eliquis API is dispersed internationally, with several key players contributing to the global supply. These sources can be classified into major regions: Asia, Europe, and North America.

Asian API Manufacturers

1. China

China remains a dominant force in pharmaceutical API manufacturing, offering cost-effective, high-volume capacity. A number of Chinese companies have developed capabilities to produce apixaban API, often exporting to global markets under stringent quality standards.

• Sino Biopharmaceutical Limited: Has expanded API manufacturing, including complex anticoagulants with appropriate certifications.
• Shanghai Zhee Pharmaceutical Co., Ltd.: Known for producing high-purity APIs with adherence to GMP standards suitable for international markets.

Advantages: Competitive pricing, large scale, robust supply capacity.

Challenges: Variable regulatory compliance and quality assurance depending on the manufacturer.

2. India

Indian API producers are renowned for quality, GMP compliance, and technological innovation in complex APIs.

• Aurobindo Pharma: Developed a high-purity apixaban API line, meeting global regulatory standards, including approval for U.S. and European markets.
• Sun Pharma: Invested in advanced synthetic capabilities for API production, including anticoagulants.

Advantages: Strong regulatory oversight, established quality standards, substantial export infrastructure.

Challenges: Capacity constraints in some suppliers, requiring precise qualification.

European API Manufacturers

European companies tend to focus on high-purity standards and regulatory compliance, often serving as primary suppliers for regulated markets.

• Vygon S.p.A. (Italy): Experienced in the synthesis of specialized APIs, compliant with EMA standards.
• Thermofisher Scientific (Germany): Supplies API intermediates and finished APIs with rigorous quality controls suitable for pharmaceuticals.

Advantages: Superior quality assurance, compliance with EU regulatory frameworks.

Challenges: Higher costs and potentially limited capacity relative to Asian suppliers.

North American API Sources

While fewer in number, U.S. and Canadian API manufacturers prioritize innovation and regulatory adherence.

• Cambrex Corporation: Specializes in high-quality APIs, including complex anticoagulants, with compliance to FDA standards.
• Incepta Pharmaceuticals: Based in the U.S., offers API manufacturing aligned with cGMP and high regulatory standards.

Advantages: Highest regulatory clarity, advanced technological capabilities.

Challenges: Higher costs and limited capacity compared to Asian counterparts.

Key Considerations in Selecting API Sources

• Regulatory Compliance: Suppliers must possess GMP certifications from recognized agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or WHO prequalification.
• Quality Assurance: Rigorous testing, including spectroscopic analysis, HPLC, residual solvents, and impurity profiling, is essential.
• Supply Reliability: Consistent delivery schedules and contingency planning are vital due to Eliquis' critical market demand.
• Cost-effectiveness: Balancing cost with quality assurances impacts overall profitability and risk management.
• Supply Chain Transparency: Traceability throughout manufacturing and transportation ensures compliance and reduces counterfeiting risks.

Regulatory and Supply Chain Challenges

The API supply chain for Eliquis faces challenges such as:

• Regulatory Harmonization: Different markets impose diverse standards; dual or multiple registrations may be needed.
• Quality Variability: Ensuring that suppliers meet strict specifications—especially for chiral and high-purity APIs.
• Geopolitical Factors: Tariffs, export restrictions, or geopolitical tensions can disrupt supply flow.
• Environmental and Sustainability Standards: Increasingly important, especially in Europe and North America, to avoid non-compliance issues.

Efforts by regulatory agencies and industry groups aim to promote transparency, strengthen quality standards, and facilitate reliable API sourcing.

Emerging Trends and Future Outlook

• Development of Synthetic Routes: Innovations aim to simplify manufacturing, reduce costs, and enhance purity.
• Growth of Contract Manufacturing: Outsourcing to Contract Manufacturing Organizations (CMOs) enhances scalability.
• Localized API Production: Countries invest in localizing API manufacturing to increase supply stability and reduce dependency on foreign sources.
• Supply Chain Digitization: Implementing blockchain and tracking systems to improve transparency and quality assurance.

Conclusion

Ensuring a reliable, high-quality supply of apixaban API is fundamental to maintaining Eliquis's global market position and complying with stringent regulatory standards. Suppliers from China, India, Europe, and North America each demonstrate unique strengths relating to cost, quality, and capacity. Strategic selection, ongoing supplier qualification, and vigilant oversight remain critical in mitigating supply risks and ensuring consistent access to this important anticoagulant.

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Key Takeaways

• Chinese and Indian manufacturers dominate global apixaban API production due to scale and affordability, but stringent qualification is essential.
• European and North American suppliers offer superior regulatory compliance, often preferred for high-stakes markets.
• Robust supplier qualification, GMP adherence, and supply chain transparency are critical to prevent disruptions.
• Innovation in synthesis and manufacturing processes enhances supply stability, reduces costs, and improves quality.
• Global geopolitical, regulatory, and environmental factors necessitate continuous market and supplier assessments.

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FAQs

1. What are the primary regions supplying API for Eliquis?
China and India are the leading suppliers due to established manufacturing capacity and cost advantages. Europe and North America also supply high-regulatory-standard APIs for quality-sensitive markets.

2. How do manufacturers ensure compliance with GMP standards for apixaban?
Manufacturers implement rigorous quality control protocols, validated processes, regular audits by regulatory agencies, and maintain detailed documentation to meet GMP standards.

3. What are the risks of sourcing API from Chinese or Indian manufacturers?
Risks include variability in quality, regulatory recognition, and logistical challenges. Due diligence, supplier qualification, and ongoing audits mitigate these risks.

4. Are there alternative synthetic routes for apixaban production?
Yes, ongoing research aims to optimize synthesis, improve stereoselectivity, and reduce step counts, which can enhance yield and reduce costs.

5. How does geopolitical stability influence API supply chains for Eliquis?
Tensions, tariffs, or export restrictions in key supplier countries can disrupt supply, emphasizing the importance of diversified sourcing and strategic stockpiling.

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References
[1] Bristol-Myers Squibb. Eliquis (apixaban) prescribing information.
[2] U.S. FDA. Drug Master Files for APIs.
[3] European Medicines Agency. Guidelines on API manufacturing.
[4] Industry reports on global API suppliers and market trends.