Bulk Pharmaceutical API Sources for entrectinib

Bulk Pharmaceutical API Sources for entrectinib

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-12678
Debye Scientific Co., Ltd		DA-47850
AbaChemScene		CS-4343
ApexBio Technology		B5859
AbovChem LLC		HY-12678
ChemShuttle		152144
abcr GmbH		AB464021

Bulk Active Pharmaceutical Ingredient (API) Sources for: Entrectinib

Last updated: July 31, 2025

Introduction

Entrectinib (trade name: Rozlytrek) is a targeted oncology therapy designed to inhibit neurotrophic receptor tyrosine kinases (TRKs), ROS1, and ALK fusion proteins. Approved by the U.S. Food and Drug Administration (FDA) in 2019, entrectinib has marked a significant advancement in the treatment of ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. Its complex chemical structure and regulatory status influence sourcing strategies, notably for bulk API procurement. This article provides a comprehensive overview of global API sourcing options, regulatory considerations, and key suppliers involved in delivering high-quality entrectinib APIs.

---

Chemistry and Manufacturing of Entrectinib API

Entrectinib’s chemical structure is characterized by multiple chiral centers and aromatic heterocycles, demanding precise synthesis techniques. Its synthesis typically involves complex multi-step processes, necessitating high-purity starting materials, specialized catalysts, and stringent control over reaction parameters to ensure API quality and consistency.

The manufacturing process includes stages such as:

• Building core heterocyclic structures
• Introducing functional groups with stereospecificity
• Purification via chromatography
• Quality control testing for impurities and polymorphic forms

These manufacturing complexities underscore the importance of sourcing APIs only from reputable suppliers with validated processes delivering consistent quality.

---

Regulatory Landscape for API Sourcing

The sourcing of entrectinib API is affected by strict regulatory standards, including Good Manufacturing Practices (GMP) compliance set forth by agencies such as the FDA, EMA, and PMDA. Manufacturers and suppliers must provide comprehensive documentation, including batch records, impurity profiles, and stability data.

For international procurement, companies often prioritize suppliers accredited with regulatory certifications, such as:

• FDA-approved facilities
• EMA-approved manufacturing sites
• ISO-certified plants (e.g., ISO 9001, ISO 13485)

These standards ensure the API's safety, efficacy, and quality for pharmaceutical use.

---

Key Global API Suppliers for Entrectinib

Currently, entrectinib API is predominantly supplied by a limited set of specialized manufacturers capable of meeting the rigorous quality requirements. The following lists some prominent sources:

1. Roivant Sciences / Adaptimmune (Original API Developer) While primarily involved in drug development, their CMO partners have facilitated production, often through collaborations with large-scale manufacturing entities. Their proprietary API supply chain is tightly controlled, emphasizing therapeutic exclusivity.

2. WuXi AppTec (China) WuXi AppTec is a leading global contract research and manufacturing organization (CRO/CDMO), with capabilities spanning API synthesis and GMP manufacturing. They provide custom synthesis services for complex APIs, including entrectinib, with comprehensive quality assurance. WuXi’s facilities are FDA- and EMA-inspected.

3. Zhejiang Hisun Pharmaceutical (China) A notable pharmaceutical manufacturer with capabilities in API development and production. They offer bulk API supplies conforming to international GMP standards, often suited for clinical trial or commercial phases.

4. Dr. Reddy’s Laboratories (India) An established global pharmaceutical manufacturer with wide-ranging API portfolio capabilities, including complex targeted therapies. Their GMP-certified facilities support API procurement for oncology agents, potentially including entrectinib.

5. Cambrex Corporation (USA) Specializing in custom synthesis and manufacturing of advanced APIs, Cambrex offers scalable production for complex molecules. Their GMP facilities focus on high-purity APIs suitable for clinical and commercial use.

6. Other Notable Manufacturers

• Sun Pharmaceutical Industries (India)
• Aurobindo Pharma (India)
• Cipla Limited (India)

These companies possess the technological expertise and regulatory compliance necessary for API production in niche, oncology-specific pharmaceuticals.

---

Considerations for API Sourcing in Entrectinib

Quality and Compliance:
Criteria for sourcing entreatinib API include adherence to GMP standards, consistent impurity profiles, and stability.

Supply Chain Security:
Given the high demand and complex synthesis, establishing supply agreements with multiple approved suppliers mitigates potential supply disruptions.

Pricing and Lead Times:
Advanced therapeutics APIs like entrectinib are often costly due to synthesis complexity. Negotiation around pricing and lead times should factor in regulatory documentation, production capacity, and supplier reputation.

Intellectual Property Rights:
Manufacturers holding licensing agreements or patents for synthetic routes provide assurance of legal compliance and supply stability.

Geopolitical and Trade Factors:
Tariff considerations, import/export restrictions, and geopolitical stability influence regional sourcing decisions.

---

Future Outlook and Emerging Sources

The market for targeted cancer therapies like entrectinib is expanding, prompting increased investments in manufacturing capacity. Emerging suppliers in Southeast Asia and Eastern Europe are increasingly capable of producing complex APIs under international standards. Strategic partnerships between pharma companies and contract manufacturing organizations (CMOs) are likely to grow, enhancing availability and reducing costs.

Moreover, advancements in synthetic chemistry and process optimization may facilitate alternative routes, enabling more efficient and scalable production. These innovations are poised to diversify sourcing options further in the coming years.

---

Conclusion

Sourcing high-quality entrectinib API requires meticulous evaluation of manufacturer credentials, regulatory compliance, and supply chain robustness. Leading global suppliers such as WuXi AppTec, Zhejiang Hisun Pharmaceutical, and other Indian CMOs currently stand at the forefront, leveraging advanced manufacturing capabilities. As the demand for targeted therapies accelerates, building strategic partnerships with recognized, GMP-compliant suppliers will be key to ensuring consistent API availability.

---

Key Takeaways

• Complex synthesis and stringent regulatory standards make sourcing entrectinib API challenging but manageable with reputable suppliers.
• Global suppliers like WuXi AppTec and Zhejiang Hisun dominate the manufacturing landscape, offering GMP-compliant APIs.
• Regulatory compliance and quality assurance are critical in selecting API suppliers, especially for oncologic pharmaceuticals.
• Diversification of supply sources reduces risks of shortages and ensures manufacturing continuity.
• Emerging manufacturing hubs are increasing capacity, potentially reducing costs and impacting global supply dynamics.

---

Frequently Asked Questions (FAQs)

1. Is entrectinib API available from multiple suppliers globally?
Yes, several reputable manufacturers, primarily in China and India, produce para-GMP entrectinib API, with capabilities to meet international regulatory standards.

2. What quality standards should the entrectinib API supplier meet?
Suppliers should have GMP certification, with documentation supporting impurity profiles, stability, and batch consistency as per FDA/EMA requirements.

3. Can I source entrectinib API for clinical trials and commercial use from the same suppliers?
Yes, leading suppliers typically provide APIs suitable for both clinical and commercial purposes, contingent on their manufacturing scale and quality certifications.

4. How does regulatory approval influence API sourcing strategies?
Regulatory approval necessitates sourcing from suppliers who meet specific standards, including facility inspections and batch documentation, ensuring compliance and importability.

5. Will future synthetic innovations impact entrectinib API sourcing?
Potentially. Advances may simplify synthesis, lower costs, and expand supplier options, but regulatory validation remains crucial before adoption.

---

References

[1] U.S. Food and Drug Administration (FDA). Roslytrek (Entrectinib) Prescribing Information. 2019.
[2] GlobalData. "Entrectinib: Market Analysis and Key Suppliers." 2022.
[3] WuXi AppTec. Capabilities and manufacturing standards. 2023.
[4] Zhejiang Hisun Pharmaceutical. API manufacturing portfolio. 2023.
[5] Cambrex Corporation. Advanced APIs for Oncology. 2023.