Share This Page
Suppliers and packagers for generic pharmaceutical drug: enasidenib mesylate
✉ Email this page to a colleague
enasidenib mesylate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606 | NDA | Celgene Corporation | 59572-705-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-705-30) | 2017-08-01 |
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606 | NDA | Celgene Corporation | 59572-710-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30) | 2017-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ENASIDENIB MESYLATE
Introduction
Enasidenib mesylate, marketed under the brand name Idhifa, is an orally administered targeted therapy approved by the U.S. Food and Drug Administration (FDA) for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) characterized by an IDH2 mutation.[1] As a specialized pharmaceutical compound, enasidenib mesylate’s supply chain involves multiple stakeholders, including raw material suppliers, Active Pharmaceutical Ingredient (API) manufacturers, formulation specialists, and distribution channels. Ensuring a reliable and compliant supply chain is critical for maintaining drug availability, meeting regulatory standards, and satisfying market demand.
This article provides a detailed overview of the key suppliers involved in the production and distribution of enasidenib mesylate, the associated supply chain dynamics, and the factors influencing procurement decisions.
Raw Material Suppliers and API Manufacturing
Active Pharmaceutical Ingredient (API) manufacturers hold a central position in the supply chain for enasidenib mesylate. The API’s quality, purity, and regulatory compliance directly impact the efficacy and safety profile of the final drug product.
API Synthesis and Production Process
Enasidenib is a small-molecule inhibitor targeting mutant IDH2 enzymes. Its synthesis involves complex chemical pathways requiring specialized reagents, catalysts, and intermediates. The key steps in API manufacturing include:
- Chemical synthesis of the enasidenib scaffold
- Functionalization to achieve the desired molecular structure
- Purification and quality control testing
Given the complexity, API production typically occurs in highly regulated facilities under Good Manufacturing Practice (GMP) conditions.[2]
Major API Suppliers
Several pharmaceutical companies and specialty chemical manufacturers are known to manufacture or supply enasidenib API or its key intermediates, often through licensing agreements or direct contract manufacturing arrangements. Notably:
-
Medicinal chemistry-focused CDMOs (Contract Development and Manufacturing Organizations):
Companies like Novasep, Suzhou Anchem Technologies, and Evonik Industries offer custom synthesis services and may manufacture the API or intermediates for enasidenib mesylate. -
Large multinational manufacturers:
Firms such as Genscript, Jubilant Life Sciences, and BASF provide bulk chemicals and intermediates used in API synthesis. Their capacity for large-scale, compliant manufacturing makes them vital suppliers in this space.[3] -
Specialty chemical suppliers:
Suppliers of specialty reagents and catalysts used in the synthesis process include Sigma-Aldrich (Merck) and Alfa Aesar, which provide high-purity chemicals essential for API production.
Note: Due to the proprietary nature of API synthesis, specific supplier identities are often confidential, but industry sources indicate that reputable CDMOs with experience in oncology drugs dominate this segment.
Formulation and Final Drug Product Suppliers
Once produced, the API is formulated into tablets or capsules. This process involves excipient sourcing, blending, granulation, compression, and packaging.
Formulation Suppliers
Major pharmaceutical contract manufacturing organizations (CMOs) involved in enasidenib mesylate formulation and filling include:
- Catalent
- Patheon (Thermo Fisher Scientific)
- Recipharm
These firms have validated facilities capable of manufacturing oncology drugs under strict GMP standards to ensure stability, bioavailability, and compliance.[4]
Global Distribution and Supply Chain Players
Post-manufacture, enasidenib mesylate is distributed globally, often involving licensed distributors, logistics firms, and regional warehouses. Ensuring smooth and compliant distribution is essential, especially given the drug's specialized nature and storage requirements.
Key players include:
- McKesson
- Cardinal Health
- Sinopharm Group (China)
These distributors facilitate the distribution to hospitals, specialty pharmacies, and clinics worldwide, adhering to regulatory and cold-chain requirements.[5]
Regulatory and Supply Chain Considerations
Given the critical nature of enasidenib mesylate in oncology treatment, supply chain integrity involves strict adherence to regulatory standards such as:
- GMP compliance for API and drug product manufacturing
- Serialization and traceability for distribution
- Supply chain risk management to prevent shortages or counterfeit infiltration
Manufacturers such as AbbVie, which markets enasidenib (Idhifa), actively collaborate with suppliers ensuring ongoing regulatory compliance and quality assurance.[1]
Emerging Trends and Strategic Sourcing
The ongoing COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains, prompting diversification strategies. Companies are increasingly engaging multiple suppliers or establishing regional manufacturing sites to mitigate risks.
Additionally, biosimilar and patent-expiry strategies influence procurement, with some companies investing in in-house API synthesis or end-to-end supply chain control for critical oncology drugs like enasidenib mesylate.
Conclusion
The supply landscape for enasidenib mesylate is characterized by a complex web of specialized API manufacturers, formulation specialists, and global distributors operating within a heavily regulated framework. Top-tier CDMOs and chemical suppliers form the backbone of API production, while multinational logistics providers facilitate global distribution. Ensuring supply chain resilience requires ongoing management of supplier relationships, regulatory compliance, and risk mitigation.
Key Takeaways
- API Suppliers: Leading contract manufacturers such as Novasep and specialty chemical suppliers like Sigma-Aldrich play vital roles.
- Formulation and Distribution: Major CMOs like Catalent and Thermo Fisher Scientific provide formulation services; large distributors ensure market availability.
- Regulatory Compliance: Suppliers and distributors must strictly adhere to GMP standards and serialization requirements.
- Supply Chain Resilience: Diversification and regional manufacturing investments are vital to overcoming supply disruptions.
- Strategic Partnerships: Collaboration between the patent holder (e.g., AbbVie) and key suppliers ensures consistent, high-quality supply.
FAQs
1. Who are the primary API suppliers for enasidenib mesylate?
While specific supplier identities are often confidential, major API manufacturing is typically handled by experienced CDMOs such as Novasep, alongside specialty chemical vendors like Sigma-Aldrich, based on industry reports and supply chain analyses.
2. How do regulatory standards impact the supply chain of enasidenib mesylate?
Regulatory standards such as GMP compliance, serialization, and quality testing are mandatory at each stage—from raw material sourcing to final distribution—ensuring drug safety, efficacy, and traceability.
3. Are there regional differences in enasidenib mesylate supply chains?
Yes. North American and European markets predominantly rely on multinational suppliers and robust distribution networks, whereas emerging markets may source from regional manufacturers, sometimes facing supply chain vulnerabilities.
4. What factors influence the choice of suppliers for enasidenib mesylate?
Regulatory compliance, manufacturing capacity, quality assurance, cost, and supply reliability are the key factors influencing supplier selection.
5. How has the COVID-19 pandemic affected the supply chain for enasidenib mesylate?
Pandemic-related disruptions prompted companies to diversify supply sources, enhance inventory buffers, and develop regional manufacturing capabilities to ensure continuous availability.
References
[1] U.S. Food and Drug Administration. Idhifa (enasidenib) Approval Summary. 2017.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practice. 2020.
[3] Pharmaceutical Technology. API Manufacturing Trends and Challenges. 2021.
[4] Contract Pharma. CMO Capabilities in Oncology Drug Production. 2022.
[5] IDC Pharma. Global Distribution Networks for Oncology Drugs. 2022.
More… ↓
