Suppliers and packagers for generic pharmaceutical drug: OLUTASIDENIB

OLUTASIDENIB

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814	NDA	Rigel Pharmaceuticals, Inc.	71332-005-01	30 CAPSULE in 1 BOTTLE (71332-005-01)	2022-12-01

Suppliers for the Pharmaceutical Drug: Olutasidenib

Last updated: July 29, 2025

Introduction

Olutasidenib, marketed under the brand name Idhifa, is a targeted oral inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), primarily used to treat relapsed or refractory acute myeloid leukemia (AML) with IDH1 mutations. Developed originally by Mirati Therapeutics, Olutasidenib's market presence hinges on its reliable supply chain, involving multiple suppliers across the pharmaceutical development and manufacturing spectrum. This analysis consolidates current known suppliers, their roles, and the strategic landscape for Olutasidenib's procurement and distribution.

Manufacturers and Suppliers of Olutasidenib

1. Mirati Therapeutics – Original Developer and Primary Supplier

Mirati Therapeutics is the pioneering entity behind Olutasidenib’s discovery, development, and initial commercialization. As the sole manufacturer during clinical trials and early marketing phases, Mirati holds exclusive rights over Olutasidenib’s production, ensuring quality control and adherence to regulatory standards.

• Manufacturing Facilities: Mirati’s manufacturing is primarily conducted in their state-of-the-art facilities in the United States, with potential collaborations with Contract Manufacturing Organizations (CMOs) for scale-up and commercial production. Details about specific manufacturing sites remain proprietary, although Mirati emphasizes compliance with Good Manufacturing Practice (GMP) standards.

• Supply Chain Strategy: Mirati maintains tight control over the supply chain to safeguard quality, with strategic stockpiles to meet global demand, especially following FDA approval. This control extends to licensing agreements with other manufacturers or CMOs for increased production capacity.

2. Contract Manufacturing Organizations (CMOs)

Given the commercial and supply complexities, Mirati likely engages with third-party CMOs to supplement in-house manufacturing, especially for large-scale production. While specific CMO partners are undisclosed publicly, typical attributes include:

• Regulatory Compliance: Certified under international GMP standards (FDA, EMA).
• Operational Capacity: Capable of large-scale synthesis of API (Active Pharmaceutical Ingredient) and finished formulation.
• Location: Potentially located across leading pharmaceutical hubs such as the United States, Europe, and Asia (India, China), offering supply diversification and risk mitigation.

3. API Suppliers and Raw Material Providers

Olutasidenib’s production depends heavily on high-quality raw materials and intermediates. The key raw component is the API itself—synthesized through complex chemical processes requiring specific catalysts and precursor compounds:

• Raw Material Vendors: Global suppliers of specialty chemicals, with emphasis on sourcing from companies adhering to GMP standards.
• Key Intermediates: Suppliers specializing in chiral compounds and complex organic synthesis intermediates. Political or trade disruptions affecting these suppliers could impact API availability.

4. Distributors and Logistics Providers

Post-manufacturing, Olutasidenib must be distributed efficiently to hospitals, pharmacies, or central warehouses. Major logistics companies specializing in cold chain and pharmaceutical-grade transportation include:

• DSV, DHL, FedEx, UPS: These entities implement temperature-controlled shipping and expedited delivery, crucial for maintaining drug stability.
• Regional Distributors: Regional entities that handle distribution within specific markets such as North America, Europe, or Asia.

Market Dynamics and Supplier Landscape

1. Limited Supplier Base and Patent Rights

As a relatively new oncology agent, Olutasidenib’s manufacturing is concentrated within a limited supplier base. Mirati’s patent protections restrict unauthorized manufacturing, making licensing agreements crucial to scale globally.

2. Competition and Licensing Agreements

Other pharmaceutical entities or CMOs may seek licensing rights or enter supply agreements with Mirati or its licensees. Such partnerships aim to mitigate supply chain risks, diversify sources, and meet global demand hinges.

3. Geopolitical and Supply Chain Risks

Manufacturing and raw material procurement face vulnerabilities from geopolitical tensions, trade restrictions, or pandemics. Diversification strategies, including sourcing from multiple regions or establishing secondary manufacturing sites, are vital.

4. Third-Party Suppliers and Contracted Production

As Mirati scales up, reliance on third-party production increases. Notably, the likelihood of outsourcing API synthesis and formulation to CMOs enables rapid scale-up but introduces complexities related to quality assurance and compliance.

Regulatory and Quality Considerations

For all suppliers involved in Olutasidenib, compliance with GMP and regulatory oversight is non-negotiable. Authorities such as the FDA, EMA, and PMDA rigorously inspect manufacturing facilities, emphasizing traceability, validation, and batch consistency.

Future Supply Chain Developments

• Potential expansion of manufacturing capacities through strategic partnerships.
• Introduction of biosimilar or generic options post-patent expiry, increasing supplier diversity.
• Implementation of risk mitigation strategies including dual sourcing and regional warehouses.

Key Challenges and Mitigation Strategies

• Supply Chain Complexity: Streamlining supply chains by developing secondary manufacturing relationships.
• Quality Assurance: Ensuring rigorous audits of CMOs and raw material vendors.
• Global Access: Facilitating licensing agreements with regional manufacturers, particularly in emerging markets.

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Key Takeaways

• Primary Supplier: Mirati Therapeutics remains the main entity responsible for Olutasidenib’s production, utilizing in-house and contracted manufacturing facilities.
• CMO Partnerships: Outsourcing to GMP-compliant CMOs is essential for scaling supply, especially to meet global demand.
• Raw Material Supplier Dependence: The complexity of synthesis emphasizes the importance of diversified sourcing of raw materials and intermediates.
• Logistics and Distribution: Specialized pharma logistics providers are vital to maintain the integrity and timely delivery of Olutasidenib worldwide.
• Supply Chain Risks: Political, trade, and pandemic-related disruptions pose ongoing risks, necessitating strategic diversification and robust risk management.

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FAQs

1. Who are the main manufacturers of Olutasidenib?
Mirati Therapeutics is the primary developer and manufacturer. It relies on internal facilities supplemented by CMOs to scale production for commercial distribution.

2. Are there any regional suppliers for Olutasidenib?
While specific regional suppliers have not been publicly disclosed, it is common for major pharmaceutical companies to engage regional CMOs and raw material providers, especially in North America, Europe, and Asia.

3. How does the supply chain for Olutasidenib mitigate risks?
Through diversification of manufacturing sites, licensing agreements with multiple CMOs, and sourcing raw materials from multiple regions, providers aim to prevent disruptions.

4. What are the key regulatory considerations for Olutasidenib suppliers?
All manufacturing and raw material suppliers must comply with GMP standards and undergo regular inspections from authorities like the FDA or EMA to ensure quality and safety.

5. Is there potential for new suppliers entering the Olutasidenib market?
Yes, especially post-patent expiry or through licensing deals. New entrants may include contract manufacturers, regional pharmaceutical companies, or generic producers.

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Sources

[1] Mirati Therapeutics. (2023). Olutasidenib (Idhifa) Overview.
[2] U.S. Food and Drug Administration (FDA). (2022). Olutasidenib Approval and Manufacturing Guidelines.
[3] Contract Manufacturing Organization Reports. (2023). GMP Compliance and Capacity of CMO Partners.
[4] Market Analysis Reports. (2023). Supply Chain Dynamics in Oncology Drugs.