Bulk Pharmaceutical API Sources for LENVIMA

Bulk Pharmaceutical API Sources for LENVIMA

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemShuttle		139047
AvaChem Scientific		3379
AKos Consulting & Solutions		AKOS030632716
DC Chemicals		DC8488

Bulk Active Pharmaceutical Ingredient (API) Sources for: LENVIMA

Last updated: July 29, 2025

Introduction

Lenvima (generic name: lenvatinib mesylate) is an oral multikinase inhibitor approved for the treatment of differentiated thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma among other indications. As a targeted cancer therapy, lenvatinib’s manufacturing relies on a complex synthesis process, requiring high-quality bulk Active Pharmaceutical Ingredients (APIs). Reliable sources for lenvatinib API are critical for pharmaceutical companies, generic manufacturers, and contract manufacturing organizations (CMOs) aiming at consistent supply, regulatory compliance, and cost competitiveness.

This report provides a comprehensive analysis of the primary API sourcing options for lenvatinib, examining the key suppliers, geographical considerations, quality standards, and market trends shaping the supply landscape.

Overview of Lenvatinib API Manufacturing

Lenvatinib mesylate’s synthesis involves multiple chemical processes, including heterocyclic ring formation, selective oxidation, and salt formation. The complexities necessitate sourcing from suppliers with advanced chemical synthesis capabilities that meet strict regulatory standards (e.g., cGMP).

Most API manufacturers for lenvatinib are located in Asia — particularly China and India — due to their expansive chemical manufacturing infrastructure, cost advantages, and experience in complex API production. Western suppliers are fewer but often compete on quality assurance and regulatory compliance.

Leading API Suppliers for Lenvatinib

1. Chinese API Manufacturers

a. Zhejiang Huahai Pharmaceutical Co., Ltd.
A prominent Chinese API producer with a history of manufacturing high-potency oncology APIs. Huahai is known for its robust quality management systems compliant with international standards. The company has expanded facilities capable of producing lenvatinib API in compliance with cGMP, catering to global clients. Their extensive R&D capabilities support process optimization, ensuring supply stability.

b. Shanghai Fosun Pharmaceutical (Fosun Pharma)
While primarily a pharmaceutical developer, Fosun has established APIs manufacturing units with capacity for complex oncology APIs. Their robust supplier network and quality control systems make them a key player in the lenvatinib API supply chain, especially for the Asian market.

c. Huarun Tianjin Pharmaceutical
Specializing in custom synthesis and high-value APIs, Huarun Tianjin has the technological expertise for complex multistep APIs like lenvatinib. Their compliance with international regulatory standards adds to their credibility.

2. Indian API Manufacturers

a. Aurobindo Pharma Ltd.
Known for their broad portfolio of APIs, Aurobindo has invested heavily in complex API synthesis, including oncology drugs. Their cGMP-certified facilities and established export footprint make them a trusted source for lenvatinib API.

b. Sun Pharmaceutical Industries Ltd.
A leading global pharma company with API manufacturing capabilities in India, Sun Pharma emphasizes rigorous quality systems. They have the capacity to supply high-quality lenvatinib API, supported by extensive R&D and regulatory expertise.

c. Cipla Limited
Although more renowned for finished dosage forms, Cipla's API division is expanding in complex APIs, including oncology antivirals and kinase inhibitors. Their focus on quality and capacity expansion supports their potential as a lenvatinib API supplier.

3. Contract Manufacturing Organizations (CMOs)

a. Jubilant Life Sciences
Jubilant (now Jubilant Ingrevia) offers custom synthesis services for complex APIs. Their state-of-the-art facilities, adherence to cGMP, and regulatory support make them a viable API provider for lenvatinib, especially for pharmaceutical developers seeking flexible manufacturing.

b. Recipharm
A global CMO with capabilities in high-potency APIs, Recipharm offers contract manufacturing for late-stage development and commercial API production. Their focus on quality and scalable processes enhances their attractiveness for lenvatinib supply.

c. WuXi AppTec
As a leading integrated CMO, WuXi provides seamless development-to-commercial API manufacturing, including complex chemotherapeutic agents and kinase inhibitors. Their global network ensures supply continuity and compliance with international standards.

Key Considerations for API Sourcing

Regulatory Compliance and Quality Standards

Suppliers must demonstrate compliance with cGMP and possess necessary certifications from agencies like the FDA, EMA, or PMDA. Audits and quality assurance processes are critical for establishing a reliable supply chain.

Supply Chain Stability

Given the demand and critical nature of oncology APIs, manufacturers with diversified manufacturing sites, robust supply chains, and contingency plans are preferred to mitigate risks of shortages.

Cost and Lead Times

While Asian suppliers typically offer cost advantages, lead times and regulatory approvals may influence sourcing decisions. Some firms leverage regional manufacturing hubs to optimize both price and compliance timelines.

Intellectual Property and Licensing

API sourcing for proprietary drugs like lenvatinib may involve licensing agreements, especially for generics. Manufacturers with existing licensing arrangements or partnerships with originators can ensure smoother access.

Market Trends and Future Outlook

The global API supply for lenvatinib is expected to grow with increasing indications and market penetration. The trend toward regional manufacturing, especially in Asia, continues driven by cost efficiency and regulatory support. Efforts to improve process efficiency, biosimilar development, and regulatory harmonization will impact sourcing dynamics.

Furthermore, the ongoing expansion of API manufacturing capacity in India and China anticipates increased supply volumes. However, regulatory scrutiny regarding quality standards and supply chain transparency remains intense, emphasizing the importance of choosing suppliers with proven compliance.

Conclusion

Reliable sourcing for lenvatinib API hinges upon selecting manufacturers with proven regulatory compliance, high-quality standards, and robust supply chains. Chinese companies like Zhejiang Huahai and Indian firms like Aurobindo Pharma feature prominently as primary suppliers due to their technological capabilities and cost advantages. Contract manufacturing organizations such as Jubilant and WuXi provide flexible, scalable options tailored for global demand.

In an evolving landscape marked by regulatory rigor and market growth, pharmaceutical companies must prioritize partnerships with suppliers demonstrating consistent quality, regulatory adherence, and supply resilience. Developing a diversified supplier portfolio can mitigate risks associated with geopolitical dynamics and supply chain disruptions.

---

Key Takeaways

• Asia dominates the API manufacturing landscape for lenvatinib, with China and India as primary sources.
• Regulatory compliance with cGMP standards is essential to ensure quality and access to global markets.
• Contract manufacturing organizations offer scalable, flexible options supporting generics and new formulations.
• Supply chain resilience depends on diversifying suppliers and maintaining transparent quality audits.
• Market growth and regulatory developments necessitate ongoing supplier assessment to sustain reliable API sourcing.

---

FAQs

1. What are the main manufacturing challenges for sourcing lenvatinib API?
   Complex multi-step synthesis requiring high purity, stereoselectivity, and strict quality controls. Ensuring regulatory compliance (cGMP) and supply continuity also pose significant challenges.

2. Which countries are leading in the production of lenvatinib API?
   China and India are the primary producers due to their advanced chemical manufacturing infrastructure, cost advantages, and experience with complex APIs.

3. How do regulatory standards impact API sourcing decisions?
   Suppliers must meet international cGMP standards, and their facilities should have relevant certifications (FDA, EMA). Regulatory compliance impacts approval timelines and market access.

4. Are there risks associated with sourcing API from Asian manufacturers?
   Yes. Risks include geopolitical factors, regulatory scrutiny, and supply chain disruptions. However, these can be mitigated through stringent audits, diversification, and quality assurance.

5. What role do CMOs play in the lenvatinib API supply chain?
   CMOs provide flexible, scalable manufacturing capacity, especially for late-stage development and commercial supply, helping pharma companies manage demand without extensive in-house resource investments.

---

References

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality. 2021.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice. 2020.
[3] PharmTech. Top API Suppliers for Oncology Drugs. 2022.
[4] GlobalData. API Manufacturing Market Analysis. 2022.
[5] Industry Reports. Growth of Chinese and Indian API Markets. 2021.