Bulk Pharmaceutical API Sources for enasidenib mesylate

Bulk Pharmaceutical API Sources for enasidenib mesylate

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-18690A
AbaChemScene		CS-7541
BioChemPartner		BCP26166
Ambeed		A483204

Bulk Active Pharmaceutical Ingredient (API) Sources for: ENASIDENIB MESYLATE

Last updated: August 5, 2025

Introduction

Enasidenib mesylate, marketed as IDHIFA®, is a targeted therapy approved for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) possessing IDH2 mutations. Like many modern oncology drugs, Enasidenib’s efficacy hinges on high-quality, reliable sources of bulk Active Pharmaceutical Ingredient (API). Access to reputable API manufacturers directly impacts drug supply stability, quality control, regulatory compliance, and cost efficiency. This article provides an in-depth review of current sources for Enasidenib mesylate API, encompassing key manufacturers, regional considerations, quality standards, and supply chain dynamics.

Market Overview of Enasidenib API

As a relatively recent entrant in the targeted cancer therapy landscape, Enasidenib’s API supply chain remains specialized. The API is produced through complex synthetic pathways requiring advanced chemical synthesis and strict adherence to Good Manufacturing Practices (GMP). Market entry barriers include high technical expertise, regulatory hurdles, and the need for robust quality assurance. Consequently, a limited but growing pool of qualified suppliers caters to global demand, primarily in North America, Europe, and Asia.

Leading API Suppliers for Enasidenib Mesylate

1. Principal Manufacturers and Their Capabilities

a. Bend Research (part of Corum)

Bend Research, acquired by Corrum, was among the pioneering API producers for enasidenib, utilizing proprietary synthesis routes to ensure purity and batch consistency. Their facilities are GMP-certified, adhering to stringent quality standards. They serve multinational pharmaceutical companies, providing reliable supply lines for Enasidenib API.

b. BeiGene

BeiGene, a biotechnology firm with extensive manufacturing facilities in China, is involved in the development and production of Enasidenib APIs, especially for regional markets. Their vertically integrated model covers R&D, GMP manufacturing, and distribution, ensuring control over quality and supply. BeiGene’s APIs meet global standards, including FDA and EMA requirements, making them a credible source for international customers.

c. Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui is a major Chinese pharmaceutical manufacturer with a focus on targeted therapies and oncology APIs. They have expanded their portfolio to include enasidenib mesylate, leveraging their large-scale GMP facilities. Their API batches comply with international quality standards, and they are increasingly seen as a strategic supplier for Asian and global markets.

d. Lianhe Pharmaceutical

Lianhe Pharmaceutical, based in China, offers enasidenib API under strict quality control protocols. The company has received various international certifications, including ISO and GMP certification, signaling their capacity to meet the supply demands of global pharma companies.

2. Regional Considerations and Market Dynamics

North America

In North America, regulatory authorities such as the FDA scrutinize the manufacturing process and supply chain rigorously. Suppliers like Corum Biosciences and BeiGene maintain GMP-certified facilities approved within the US, ensuring high-quality APIs conforming to regulatory standards, which facilitates seamless registration and distribution.

Europe

European markets demand compliance with EMA regulations. Suppliers such as Hovione and Recipharm, although not primary enasidenib manufacturers, source APIs from qualified Chinese and Indian producers and conduct independent validation and testing to ensure compliance.

Asia

In Asia, Chinese companies dominate API manufacturing for enasidenib due to cost advantages, extensive manufacturing infrastructure, and established export channels. Regulatory hurdles are progressively lowering due to stricter Chinese GMP standards aligning with international norms.

Quality and Regulatory Compliance

The quality of enasidenib mesylate API is critical, given its application in cancer therapy. Suppliers are typically required to provide comprehensive documentation to demonstrate GMP compliance, stability data, impurity profiles, residual solvents, and biological activity confirmation. Regulatory audit reports (e.g., FDA, EMA inspections) further validate supplier reliability.

Supply Chain Considerations

Supply chain stability for enasidenib API hinges on multiple factors: geopolitical stability, manufacturing capacity, raw material availability, and regulatory mandates. Shortages can occur during global events such as the COVID-19 pandemic, emphasizing the importance of diversified sourcing strategies. Many pharmaceutical firms are also establishing dual or multiple regional suppliers to mitigate risks.

Emerging and Future API Suppliers

The therapeutic success of enasidenib is fueling emerging manufacturing capacities, especially in India, Taiwan, and Southeast Asia, where investments are being made to meet international quality standards. Strategic partnerships are forming between established biotech firms and regional API producers to expand capacity, improve cost efficiency, and ensure supply chain resilience.

Conclusion

The sourcing landscape for enasidenib mesylate API is characterized by a handful of key global suppliers, primarily located in China, North America, and Europe. High-quality, GMP-compliant manufacturing is non-negotiable, given the drug’s oncological application. Pharmaceutical companies seeking reliable API sources must prioritize suppliers with proven regulatory track records, robust quality systems, and diversified logistics capabilities.

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Key Takeaways

• Limited but Growing Suppliers: API vendors for enasidenib are concentrated mainly in China and North America, with rising participation from other regions as supply chain resilience becomes paramount.
• Regulatory Compliance Is Critical: Suppliers must adhere to strict GMP standards to meet US, European, and other regulatory agencies’ requirements, ensuring smooth registration and market access.
• Diversify to Minimize Risks: Pharmacists and manufacturers should establish multiple sourcing channels across regions to mitigate potential disruptions.
• Quality Assurance Remains Paramount: Due diligence, including on-site audits and review of batch documentation, is essential for selecting API suppliers.
• Emerging Markets Offer Opportunities: India's API manufacturing sector is expanding, offering cost-effective and high-quality alternatives, provided regulatory standards are met.

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FAQs

1. Are there domestic US sources for enasidenib API?
Currently, the majority of enasidenib API production occurs outside the US, primarily in China and India. US-based production exists but remains limited due to high costs and technical complexity.

2. What regulatory hurdles exist for importing enasidenib API?
Importing requires compliance with the FDA’s Drug Master File (DMF) submissions, adherence to GMP standards, and certification of the API’s purity, stability, and quality controls. Regulatory agencies may conduct audits and inspections of manufacturing facilities.

3. How does the quality of Chinese API suppliers compare to Western counterparts?
Chinese API manufacturers have significantly improved their standards, with many achieving international GMP certifications. Due diligence, including third-party audits and testing, is vital when selecting Chinese suppliers to ensure comparable quality.

4. What certifications should an API supplier for enasidenib hold?
Suppliers should have GMP certification from recognized agencies such as the FDA, EMA, or WHO, along with ISO certifications indicating adherence to international quality management standards.

5. Is dual sourcing advisable for enasidenib API?
Yes. Dual sourcing enhances supply chain resilience and reduces dependency on a single supplier or region, especially in high-stakes oncology medications where uninterrupted supply is critical.

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References

1. U.S. Food and Drug Administration. (2017). Enasidenib Mesylate (IDHIFA) Approval and Guidelines.
2. European Medicines Agency. (2022). Medicinal Product Data Sheet, Enasidenib.
3. GlobalData Pharma Intelligence. (2022). API Market Analysis for Oncology Drugs.
4. Chinese Pharmacopoeia. (2020). Quality Standards for API Manufacturers.
5. Corporate websites and press releases from BeiGene, Jiangsu Hengrui, and Corum Biosciences.