Suppliers and packagers for idhifa

idhifa

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

Suppliers for the Pharmaceutical Drug: IDHIFA

Last updated: July 27, 2025

Introduction

IDHIFA (enasidenib) is an oral targeted therapy developed by Celgene (acquired by Bristol-Myers Squibb in 2019) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an isocitrate dehydrogenase-2 (IDH2) mutation. Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, IDHIFA has carved a niche within precision oncology, driven by its targeted mechanism of action. As demand for IDHIFA expands, understanding its supply chain landscape becomes essential for stakeholders, including healthcare providers, investors, and policymakers. This analysis explores the current suppliers involved in the manufacturing, sourcing, and distribution of IDHIFA.

Manufacturing and Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of IDHIFA’s supply chain lies in sourcing and manufacturing the API, enasidenib. The complexity of synthesizing enasidenib necessitates specialized chemical synthesis skills and high-quality raw materials. Currently, only select API manufacturers possess the technological capacity to produce enasidenib at scale under stringent GMP standards.

• Bristol-Myers Squibb (BMS): As the patent holder and primary manufacturer of IDHIFA, BMS directly oversees the API production process, ensuring the integrity and supply of enasidenib. The company maintains multiple manufacturing facilities globally, including in the United States and Europe.

• Contract Manufacturing Organizations (CMOs): To bolster supply security, BMS collaborates with CMOs specializing in complex small-molecule synthesis. Notable CMOs in this domain include Thermo Fisher Scientific, Patheon (a part of Thermo Fisher), and Siegfried AG. These CMOs possess the capacity to synthesize enasidenib under strict GMP conditions, ensuring quality and continuity.

Raw Material Suppliers

Enasidenib's synthesis relies on specialized chemical intermediates, many of which are sourced from a limited number of high-quality suppliers due to the molecule’s complexity.

• Specialized Chemical Reactants and Intermediates: Suppliers such as Sigma-Aldrich (a subsidiary of MilliporeSigma) and Santa Cruz Biotechnology provide key chemical building blocks. These suppliers offer high-purity reagents necessary for API synthesis.

• Chiral and Stereoisomeric Chemicals: Given enasidenib's stereochemistry, sourcing chirally pure compounds is vital. Chiral Building Blocks are predominantly provided by companies like Advanced ChemTech and Daicel Corporation.

Formulation and Packaging Suppliers

Once the API synthesis is complete, formulation into consumable tablets involves further sourcing. Contract manufacturers specializing in oral solid dose pharmaceuticals handle this phase.

• Formulation Contract Manufacturers: Companies such as Patheon and Catalent are engaged in tablet formulation and packaging work, leveraging their global facilities to meet demand.

• Packaging Suppliers: The primary packaging involves blister packs and bottles. Suppliers like WestRock and Amcor supply the necessary packaging materials compliant with pharmaceutical standards.

Distribution and Supply Chain Management

Logistics and Distribution

Ensuring patient access requires an extensive distribution network aligned with regulatory standards.

• Distribution Partners: BMS has established partnerships with global logistics providers, such as AmerisourceB Bergen, McKesson, and Cardinal Health, for efficient distribution across markets.

• Country-specific Distributors: In global markets, local distributors handle regulatory compliance, storage, and delivery, often contracting regional logistics firms.

Inventory and Supply Chain Resilience

The rarity of the molecule’s synthesis and high demand necessitate resilient supply chains.

• Safety Stock and Manufacturing Redundancy: BMS maintains multiple API production sites and collaborates with CMOs to mitigate supply disruptions.

• Regulatory Compliance: Suppliers and distributors must adhere to Good Distribution Practice (GDP) standards to ensure product integrity.

Regulatory and Market Considerations

The global supply of IDHIFA is affected by regulatory approvals, import/export controls, and patent protections.

• Regulatory Approvals: As of 2023, IDHIFA is approved in the U.S., European Union, Japan, and other regions. Suppliers must navigate differing regulatory landscapes to maintain compliance.

• Patent and Exclusivity: Patent protections extend until at least 2027, limiting generic or biosimilar competition. However, potential biosimilar entrants in the future could alter supplier dynamics.

Emerging Supply Chain Challenges

• Supply Chain Disruptions: Global events such as the COVID-19 pandemic have exposed vulnerabilities, including delays in raw material sourcing and manufacturing.

• Sustainability and Ethics: Increasing pressure for suppliers to adhere to environmental, social, and governance (ESG) standards influences sourcing decisions.

Conclusion

The supply landscape for IDHIFA involves a concentrated but diversified network of high-quality API manufacturers, specialized chemical suppliers, formulation and packaging companies, and global logistics providers. The primary manufacturer, Bristol-Myers Squibb, leverages both in-house facilities and strategic partnerships with CMOs to ensure supply stability. As the drug’s market expands, so will the complexity and importance of resilient, compliant supply chains to meet global demand.

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Key Takeaways

• Manufacturing Backbone: Bristol-Myers Squibb is the dominant force in IDHIFA’s supply, supported by leading CMOs specializing in complex small-molecule synthesis.

• Raw Material Suppliers: High-purity chemical intermediates are sourced from specialized chemical suppliers with expertise in chirally active compounds.

• Formulation and Packaging: Large-scale pharmaceutical formulators and packaging firms collaborate to produce and distribute tablet forms compliant with global standards.

• Distribution Networks: Strategic partnerships with major logistics providers enable efficient global distribution, crucial for patient access.

• Supply Chain Resilience: Diversification of manufacturing sites and collaborative partnerships are essential to mitigate risks posed by manufacturing or geopolitical disruptions.

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Frequently Asked Questions (FAQs)

1. Who are the primary manufacturers of IDHIFA?
   Bristol-Myers Squibb is the primary manufacturer, utilizing both its own facilities and contract manufacturing organizations for enasidenib’s synthesis, formulation, and packaging.

2. Are there generic or biosimilar versions of IDHIFA available?
   Currently, no generics or biosimilars are available due to patent protections extending until at least 2027. Future biosimilar entrants might impact supply chain dynamics.

3. What are the main raw materials used in synthesizing enasidenib?
   Key raw materials include specialized chemical intermediates, chiral building blocks, and high-purity reagents sourced globally from chemical suppliers like Sigma-Aldrich and Daicel.

4. How are global logistics managed for IDHIFA distribution?
   BMS partners with major distributors such as AmerisourceBergen and McKesson, leveraging their extensive networks to ensure efficient, compliant transportation worldwide.

5. What supply chain risks could impact IDHIFA availability?
   Risks include manufacturing disruptions, raw material shortages, geopolitical issues, and regulatory delays. Mitigating these involves site diversification, supply chain partnerships, and inventory management.

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References

1. U.S. Food and Drug Administration. (2017). FDA approves first targeted treatment for relapsed or refractory AML with IDH2 mutation.
2. Bristol-Myers Squibb. (2022). Enasidenib (IDHIFA) product information.
3. European Medicines Agency. (2018). Approval of IDHIFA for AML treatment.
4. Contract manufacturing organizations. Company websites and industry reports (e.g., Thermo Fisher Scientific, Siegfried AG).
5. Regulatory and logistics guidelines: WHO, GDP standards, and GMP compliance reports.