MIRALUMA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-20	20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-55	5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL	1990-12-20
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-003-20	20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL	1990-12-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

MIRALUMA (cabozantinib) is an orally administered tyrosine kinase inhibitor launched by Exelixis, Inc., primarily used for treating advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). As with many cancer therapeutics, ensuring a reliable supply chain for MIRALUMA involves identifying key suppliers across various stages of drug manufacturing, from active pharmaceutical ingredient (API) production to formulation, packaging, and distribution. This article provides an in-depth analysis of current suppliers for MIRALUMA, emphasizing their roles, market presence, and strategic importance within the pharmaceutical supply ecosystem.

Overview of MIRALUMA and its Manufacturing Process

MIRALUMA's active ingredient, cabozantinib, is a small-molecule tyrosine kinase inhibitor targeting multiple kinases associated with tumor growth and angiogenesis, including MET, VEGFR2, and AXL. The manufacturing of cabozantinib involves complex synthetic chemistry processes requiring high-purity APIs and sophisticated formulation techniques.

The supply chain encompasses:

API manufacturing: Synthesis and purification of cabozantinib.
Formulation and Finished Dosage Production: Converting APIs into tablets.
Packaging and Distribution: Ensuring stability and compliance with regulatory standards.

Each stage involves specialized suppliers, predominantly based in regions with advanced pharmaceutical manufacturing capabilities such as North America, Europe, and Asia.

Key Suppliers for MIRALUMA

1. Active Pharmaceutical Ingredient (API) Suppliers

The API for MIRALUMA, cabozantinib, is produced by a limited number of high-capacity manufacturers due to its complex synthesis and stringent quality requirements.

Exelixis, Inc. In-House Production

While external suppliers handle much of the API production, Exelixis maintains critical control over API synthesis to ensure consistency and regulatory compliance, especially for clinical trial supplies and initial commercial batches.
Contract Manufacturing Organizations (CMOs)

A significant portion of cabozantinib API is supplied via contract manufacturers. Notably:
- Hercules, Inc. and Jubilant Life Sciences (India):
Jubilant Life Sciences has a prominent role in producing APIs for various kinase inhibitors, including TAC-based compounds. Although not officially confirmed for cabozantinib, their capacity indicates potential involvement.
- Zhejiang Medicine Co., Ltd. (China):
As a leading API manufacturer specializing in small-molecule pharmaceuticals, Zhejiang Medicine offers manufacturing solutions for oncology drugs, including kinase inhibitors.
- Hikma Pharmaceuticals (UK):
Hikma has been involved in the synthesis of APIs under licensed and partner agreements, though specific involvement with cabozantinib remains unconfirmed publicly.

2. Formulation and Finished Dosage Suppliers

The conversion of API into commercial tablets involves multiple pharmaceutical contract manufacturers, many of which are regional or multinational companies specializing in oral solid dosage forms.

Patheon (a Thermo Fisher Scientific Brand)

A major contract manufacturing organization (CMO) with facilities in North America and Europe, Patheon has capabilities for formulation, tablet compression, and packaging of oncological agents like MIRALUMA.
Catalent Pharma Solutions

Catalent supports late-stage development and commercial manufacturing of complex oral dosage forms, providing fill-finish services crucial for MIRALUMA's distribution.
Recipharm

A European-based CMO, Recipharm offers large-scale manufacturing of oral solids, including cancer therapies, with facilities equipped to handle stability-sensitive drugs.

3. Packaging and Distribution

Ensuring the stability and proper handling of MIRALUMA tablets relies on specialized packaging suppliers:

Uhlmann Packaging

Renowned for blistering and bottle manufacturing, Uhlmann provides compliant packaging solutions that meet pharmaceutical standards.
Siemens Healthineers (E-beam sterilization)

Involved in sterilization processes for certain packaging components, though less common for oral solid drugs like MIRALUMA.

Regional and Strategic Considerations

The global nature of MIRALUMA’s supply chain introduces both opportunities and risks:

Asia-Pacific Region: China and India serve as major API manufacturing hubs due to cost advantages and scalable capacities. Companies like Zhejiang Medicine and Jubilant Life Sciences are key players.
North America and Europe: These regions host high-quality formulation and packaging facilities, ensuring adherence to strict regulatory standards.
Supply Chain Risks: Dependence on regional suppliers, geopolitical tensions, and disruptions like the COVID-19 pandemic have prompted many pharmaceutical companies to diversify supplier bases.

Regulatory and Quality Assurance Perspectives

Suppliers involved in MIRALUMA's manufacturing process must comply with Good Manufacturing Practices (GMP), ensuring drug safety, efficacy, and quality. Regulatory authorities like the FDA, EMA, and NMPA (China) monitor supplier compliance thoroughly. Exelixis leverages strict quality audits and supplier qualification processes to secure a reliable supply chain.

Emerging Trends and Future Outlook

As the market for kinase inhibitors expands, suppliers are investing in technological innovations such as continuous manufacturing, advanced chemical synthesis, and digitized supply chain management. This evolution aims to enhance capacity, reduce costs, and mitigate risks associated with supply shortages.

Exelixis's strategic partnerships and supply agreements with CMOs indicate a focus on increasing manufacturing flexibility and geographic diversification, aligning with industry best practices.

Key Takeaways

Limited but Diverse Supplier Base: MIRALUMA’s supply chain hinges on a handful of specialized API manufacturers primarily in Asia and Europe, with formulation and packaging handled by global CMOs.
Strategic Supplier Relationships: Exelixis maintains tight control through quality audits and direct collaborations to secure reliable supply lines despite regional variations.
Supply Chain Risks: The global nature exposes MIRALUMA to geopolitical, logistical, and pandemic-related risks; diversification and contingency planning are critical.
Regulatory Compliance: Suppliers must meet rigorous GMP standards to ensure product quality and regulatory approval.
Emerging Industry Trends: Adoption of innovative manufacturing technologies and supply chain digitization will enhance efficiency and resilience.

FAQs

1. Who are the primary API suppliers for MIRALUMA?
While specific API manufacturers for cabozantinib remain undisclosed, major pharmaceutical regions—including China (Zhejiang Medicine), India (Jubilant Life Sciences), and Europe (Hikma, if involved)—are key contenders in API production, with licensed and contract manufacturing arrangements.

2. Are there alternative suppliers in case of supply disruptions?
Yes. Companies like Zhejiang Medicine and Jubilant Life Sciences are expanding capacities, and Exelixis continuously evaluates alternate sources to mitigate supply risks.

3. How does regulatory compliance influence supplier selection?
Suppliers must adhere to GMP standards enforced by agencies such as the FDA and EMA, ensuring safe, effective, and high-quality drug manufacturing.

4. Are there plans to localize more of the MIRALUMA supply chain?
In response to geopolitical and pandemic challenges, pharma companies are increasingly localizing or diversifying supply chains to regions like North America and Europe.

5. What technological advances are impacting MIRALUMA’s supply chain?
Implementing continuous manufacturing and digital supply chain management improves efficiency, reduces costs, and enhances risk mitigation.

References

Exelixis, Inc. Corporate Website. MIRALUMA (cabozantinib).
U.S. Food and Drug Administration. Drug Approvals and Regulatory Decisions.
Pharma Manufacturing News. Global API Market Analysis.
Contract Pharma. CMO Profiles & Capabilities.
Industry Reports. Global Oncology Drug Supply Chain Trends.

Suppliers and packagers for MIRALUMA

MIRALUMA

Suppliers for the Pharmaceutical Drug: MIRALUMA