Bulk Pharmaceutical API Sources for CRIZOTINIB

Bulk Pharmaceutical API Sources for CRIZOTINIB

Vendor	Vendor Homepage	Vendor Sku	API Url
Ennopharm		EN002685
ISpharm		I14-14837
ChemMol		44027072

Bulk Active Pharmaceutical Ingredient (API) Sources for Crizotinib

Last updated: July 28, 2025

Introduction

Crizotinib is a targeted tyrosine kinase inhibitor primarily used for treating non-small cell lung cancer (NSCLC) harboring ALK (anaplastic lymphoma kinase) and ROS1 genetic alterations. Since its approval by the U.S. Food and Drug Administration (FDA) in 2011, demand for crizotinib has surged globally. Central to its manufacturing process is sourcing high-quality bulk Active Pharmaceutical Ingredient (API), which directly influences drug safety, efficacy, regulatory compliance, and cost efficiency.

This report explores core API sourcing strategies, key suppliers, market dynamics, and quality considerations pertinent for pharmaceutical companies, wholesalers, or integrators involved in the procurement of crizotinib API.

Overview of Crizotinib and Its API

Crizotinib's chemical name is N-{4-[(1R)-1-(2,6-dichlorophenyl)ethyl]piperazin-1-yl}4-(morpholin-4-yl)thieno[3,2-d]pyrimidine-6-carboxamide. Its synthesis involves complex multi-step routes, often requiring specialized reagents, high purity standards, and stringent process controls. The API must conform to pharmacopeial standards such as USP, EP, or JP, ensuring batch-to-batch consistency.

Major API Supply Sources

1. Leading Manufacturers in Asia

a. Chinese API Manufacturers

China remains the dominant supplier of bulk APIs, including crizotinib, due to large-scale manufacturing capacity, cost advantages, and a well-established supply chain infrastructure.

• Chengdu Bangda Pharmaceutical Co., Ltd.

  Specializes in oncology APIs, including crizotinib. Offers bulk API with comprehensive quality certifications, such as ISO 9001 and CGMP compliance. Their manufacturing facilities are registered with the National Medical Products Administration (NMPA).

• Shanghai Fosun Pharmaceutical Group

  As part of a major pharmaceutical conglomerate, Fosun produces APIs, including specialty oncology molecules. They are known for integrating R&D with manufacturing, ensuring supply stability.

• Zhejiang NHU Co., Ltd.

  Provides APIs for various therapeutic classes, including targeted therapies. Their crizotinib API offerings focus on high purity and competitive pricing.

b. Indian API Manufacturers

India's pharma sector is recognized for cost-effective manufacturing and quality standards aligned with international regulatory agencies.

• Granules India

  Supplies APIs and intermediates, with some capacity for complex oncology APIs like crizotinib, focusing on compliance with USFDA standards.

• Mannara Pharma

  Specializes in custom synthesis and active pharmaceutical ingredients for targeted cancer therapies, including crizotinib, with adherence to cGMP standards.

2. North American and European Sources

While less prevalent, some specialized manufacturers and contract manufacturing organizations (CMOs) supply bulk crizotinib API, primarily for highly regulated markets.

• Larkrer Pharma (Europe)

  Offers high-quality APIs with dedicated cGMP manufacturing facilities, catering to advanced markets that demand stringent quality assurance.

• CROs and CMOs in North America

  Few pharmaceutical contract manufacturers in the U.S. and Canada possess the specialized capacity for complex APIs like crizotinib. Often, these entities perform custom synthesis or scale-up for global clients.

3. Contract Manufacturing and Synthesis

Many pharmaceutical companies rely on contract manufacturing organizations for bulk API production, especially for complex compounds like crizotinib. These CMOs often have proprietary synthesis routes, quality systems aligned with international standards, and can scale production as per client requirements.

Market Dynamics and Trends

a. Supply Chain Concentration and Risks

Most crizotinib API production is concentrated among Chinese and Indian manufacturers, raising concerns about supply chain disruptions, regulatory scrutiny, and geopolitical factors. Recent global events, such as supply chain interruptions during the COVID-19 pandemic, have spotlighted the need for diversified sourcing options.

b. Quality and Regulatory Compliance

Regulatory agencies such as the FDA, EMA, and NMPA prioritize API quality and manufacturing transparency. API suppliers with current Good Manufacturing Practices (cGMP), comprehensive quality documentation, and successful inspections are preferred.

c. Cost and Pricing Dynamics

Cost competitiveness is a significant driver. Indian manufacturers generally offer lower prices, while Chinese and European suppliers may justify premium pricing through higher quality or regulatory compliance. Price elasticity influences procurement strategies amid market pressures for affordable cancer therapies.

d. Supply Flexibility and Lead Times

Manufacturers capable of rapid scale-up, punctual delivery, and reliable supply are favored, especially given the urgency of oncology treatments. Integration of APIs into global supply chains demands strict adherence to delivery timelines.

Quality Considerations in Selecting API Suppliers

• Regulatory Certifications: ISO, GMP, FDA approval, and evidence of compliant manufacturing practices.
• Purity and Standards: API purity typically >99%, with detailed batch testing certificates.
• Traceability: Robust documentation and lot tracing for regulatory audits.
• Stability Data: Demonstrated stability of API during storage and transportation.
• Environmental and Ethical Standards: Chemical waste management, labor practices, and sustainability.

Logistics and Procurement Strategies

Companies should develop a comprehensive supplier qualification process, including on-site audits, sample testing, and verification of regulatory compliance. Establishing multiple sourcing arrangements mitigates supply risk.

Advanced procurement involves long-term purchasing agreements, inventory buffering, and collaboration with CMOs to manage demand fluctuations effectively.

Emerging Trends and Future Outlook

• Synthetic Route Innovations: New synthetic processes may reduce costs and improve yield, influencing future API availability.
• Regulatory Stringency: Enhanced regulation may favor suppliers with superior compliance records over lower-cost alternatives.
• Global Supply Chain Diversification: To counteract concentration risks, companies are exploring alternative sources in Southeast Asia, South America, and emerging markets.
• Vertical Integration: Some pharmaceutical firms are investing directly in API manufacturing to secure supply and control quality.

Key Takeaways

• The majority of crizotinib API is sourced from Chinese and Indian manufacturers, offering cost-effective bulk options but requiring due diligence on quality.
• Regulatory compliance and quality assurance are paramount; suppliers with cGMP certification and proven batch consistency should be prioritized.
• Supply chain resilience depends on diversification, robust qualification processes, and strategic supplier relationships.
• Market and geopolitical factors influence pricing power and sourcing strategies; keeping abreast of regulatory updates helps ensure ongoing supply.
• Innovation in synthesis processes and capacity expansion forecasts will shape future supply landscapes.

Conclusion

Secure, high-quality bulk API sourcing for crizotinib hinges on aligning cost, regulatory compliance, and supply reliability. globalization has broadened options, but risk mitigation requires thorough supplier qualification and diversification strategies. As demand for targeted oncology treatments like crizotinib persists, developing resilient supply chains will be crucial for manufacturers, wholesalers, and healthcare providers aiming to deliver effective therapies efficiently.

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FAQs

1. What are the primary regions for sourcing crizotinib API?
Mainly China and India, with some European and North American CMOs providing specialized manufacturing services.

2. How can I verify the quality of a crizotinib API supplier?
Check for certifications like cGMP, ISO, and regulatory approvals; review batch testing reports; and conduct on-site audits if possible.

3. What factors influence the choice between different API suppliers?
Cost, quality standards, regulatory compliance, supply stability, lead times, and supplier reputation.

4. Are there alternative synthetic routes for crizotinib API?
Yes, ongoing research explores more efficient routes to reduce costs and environmental impact, potentially broadening future supply options.

5. How does geopolitical risk affect crizotinib API sourcing?
Concentration in certain regions exposes supply chains to geopolitical and policy risks; diversification can mitigate this.

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References

[1] U.S. Food & Drug Administration (FDA). Crizotinib (Xalkori) Drug Approval. 2011.
[2] Pharmaproducts and API manufacturer directories.
[3] Industry reports on global API market trends.
[4] World Health Organization (WHO). Good Manufacturing Practices guidelines.
[5] European Medicines Agency (EMA). Regulatory requirements for APIs.