Suppliers and packagers for apixaban

apixaban

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax	APIXABAN	apixaban	TABLET;ORAL	209810	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1721-01	10 BLISTER PACK in 1 CARTON (0115-1721-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1721-15)	2018-08-31
Impax	APIXABAN	apixaban	TABLET;ORAL	209810	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1721-03	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-03)	2018-08-31
Impax	APIXABAN	apixaban	TABLET;ORAL	209810	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1721-13	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-13)	2018-08-31
Impax	APIXABAN	apixaban	TABLET;ORAL	209810	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1722-01	10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15)	2018-08-31

Suppliers for the Pharmaceutical Drug: APIXABAN

Last updated: August 22, 2025

Introduction

Apixaban, marketed under brand names such as Eliquis, is an oral anticoagulant used primarily for the prevention and treatment of thrombosis, including atrial fibrillation-related stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). As a direct Factor Xa inhibitor, apixaban's global demand underscores the importance of a secure, reliable supply chain. Its manufacturing hinges on complex chemical synthesis, requiring high-quality active pharmaceutical ingredient (API) sourcing from specialized suppliers. This report dissects the leading API suppliers for apixaban, analyzing their roles in the pharmaceutical supply chain, capabilities, regulatory compliance, and strategic implications for stakeholders.

Overview of Apixaban Production

Apixaban synthesis involves multi-step chemical processes centered on precise stereochemistry and high purity standards. The API's manufacture demands advanced chemical intermediates and stringent quality controls, positioning suppliers primarily in regions with established pharmaceutical chemical manufacturing hubs, such as India, China, and certain European countries. Ensuring quality and consistent supply has become more critical amid global supply chain disruptions and increasing regulatory scrutiny.

Major API Suppliers for Apixaban

1. Zhejiang Hailishun Pharmaceutical Co., Ltd. (China)

Zhejiang Hailishun is among the prominent Chinese API manufacturers specializing in high-value, complex molecules such as apixaban. Known for robust manufacturing capabilities, Hailishun invests heavily in quality systems compliant with Good Manufacturing Practice (GMP) standards. Their manufacturing facility in Zhejiang employs advanced chemical synthesis techniques, ensuring high purity (>99%) API batches.

Strengths:

• Established expertise in direct FXa inhibitors
• Competitive pricing
• GMP certification aligned with international standards

Challenges:

• Navigating rigorous international regulatory approvals due to geopolitical concerns
• Ensuring consistent supply amidst regional supply chain disruptions

2. Dr. Reddy's Laboratories (India)

Dr. Reddy’s is a global pharmaceutical and API manufacturer offering apixaban at scale. Their facilities in Hyderabad meet stringent global regulatory standards, including US FDA and EMA approvals, facilitating international distribution.

Strengths:

• Proven track record in manufacturing complex APIs
• Extensive quality assurance infrastructure
• Ability to supply large volumes to global markets

Challenges:

• Cost sensitivity due to manufacturing scale
• Maintaining supply chain elasticity amidst fluctuating demand

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Huahai is a significant player, previously known for their manufacturing of pharmaceuticals in the anticoagulant class. Their expertise in FXa inhibitor APIs, including apixaban, positions them as a strategically vital supplier.

Strengths:

• Advanced synthesis and process development capabilities
• Significant capacity for API production in China

Challenges:

• Past regulatory scrutiny (notably in heparin incidents) may impact perceptions
• Quality assurance must maintain rigorous standards to sustain credibility

4. Teva Pharmaceutical Industries Ltd. (Israel)

While primarily known as a generic drug manufacturer, Teva has established API manufacturing capabilities, including for apixaban. Their diversified manufacturing footprint supports supply chain resilience.

Strengths:

• Global distribution network
• Focused quality management systems

Challenges:

• Capacity limitations relative to high-volume demand segments
• Potential reliance on third-party suppliers for some intermediates

5. Other Notable Suppliers

Besides the prominent players, several smaller or emerging suppliers serve niche markets or provide initial batches for clinical development. Notably, several Indian and Chinese API manufacturers offer apixaban intermediates, but their regulatory clearance status varies.

Regulatory Landscape and Impact on Suppliers

Suppliers must navigate complex regulatory environments, including compliance with FDA, EMA, PMDA (Japan), and other national agencies. Market access hinges on GMP accreditation, validated manufacturing processes, and transparent quality documentation. Recent recall incidents and quality concerns in some Chinese suppliers have underscored the importance of robust quality controls and regulatory audits.

Supply Chain Risks and Strategic Considerations

The API supply chain for apixaban faces multiple risks: geopolitical tensions, trade restrictions, sourcing of raw materials, and manufacturing disruptions. Diversification of suppliers, geographic dispersion, and adherence to international quality standards mitigate these risks.

Key considerations include:

• Certifying suppliers according to international standards (e.g., ISO, GMP)
• Developing dual-sourcing strategies to prevent shortages
• Evaluating supplier track records for quality and compliance
• Engaging in long-term strategic partnerships to ensure supply stability

Emerging Trends and Future Outlook

The increasing adoption of apixaban worldwide, coupled with patent expiries and biosimilar entries, intensifies demand for high-quality APIs. Suppliers investing in process innovation, sustainability, and regulatory compliance will sustain competitive advantages. Furthermore, the move toward integrated manufacturing and regional API hubs enables resilience against supply disruptions.

Conclusion

The global apixaban API supply landscape features a diverse array of suppliers, predominantly based in China and India, with established processes and regulatory pathways. Strategic partnerships, rigorous quality management, and supply chain diversification are critical for stakeholders to secure reliable API sources amid market expansion and geopolitical uncertainties.

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Key Takeaways

• Leading apixaban API suppliers include Zhejiang Hailishun, Dr. Reddy's, Zhejiang Huahai, and Teva, each with strengths in capacity, quality, and regulatory compliance.
• Ensuring supplier GMP certification and regulatory approval is vital for market access and quality assurance.
• Diversification and strategic partnerships mitigate supply chain risks associated with geopolitical, logistical, and regulatory factors.
• Investment in process innovation and compliance will position suppliers favorably in the growing anticoagulant market.
• Stakeholders should continuously monitor geopolitical developments and regulatory requirements to maintain resilient and compliant supply chains.

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FAQs

1. What are the key criteria for selecting an apixaban API supplier?
Criteria include GMP certification, regulatory track record, manufacturing capacity, quality consistency, supply chain flexibility, and cost competitiveness.

2. How does geopolitical risk influence the apixaban API supply chain?
Geopolitical tensions may disrupt manufacturing, export policies, or impose tariffs, leading to potential shortages. Diversification and local manufacturing integration help mitigate this risk.

3. Are there any regulatory concerns with Chinese API suppliers?
Historically, some Chinese suppliers have faced regulatory scrutiny; however, many now adhere to international GMP standards. Due diligence and verification audits are advised.

4. What role does process innovation play in apixaban API manufacturing?
Process innovation enhances yield, purity, and cost-efficiency, enabling suppliers to meet growing global demand and maintain compliance with evolving regulations.

5. How can pharmaceutical companies ensure the quality of apixaban APIs?
Through thorough qualification of suppliers, validation of manufacturing processes, continuous quality audits, and adherence to international standards such as ICH Q7 and GMP certifications.

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Sources:

1. Pfizer, Eliquis API Summary.
2. "Global API Market Report," IQVIA Insights, 2022.
3. U.S. FDA Drug Master Files and GMP compliance reports.
4. Zhejiang Hailishun Pharmaceutical official disclosures.
5. Company annual reports and manufacturing disclosures from Dr. Reddy’s, Huahai, and Teva.