Suppliers and packagers for generic pharmaceutical drug: belumosudil mesylate

belumosudil 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
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783	NDA	Kadmon Pharmaceuticals, LLC	79802-200-30	1 BOTTLE in 1 CARTON (79802-200-30) / 30 TABLET in 1 BOTTLE	2021-07-16

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Belumosudil Mesylate

Introduction
Belumosudil mesylate, marketed under the brand name Rezlidhia, is a novel kinase inhibitor primarily developed for the treatment of specific hematologic conditions, including chronic graft-versus-host disease (cGVHD). The drug's unique mechanism targets ROCK2 (Rho-associated coiled-coil containing protein kinase 2) pathways, making it a promising therapeutic in complex immune-related disorders. As the demand for belumosudil mesylate grows, understanding its suppliers is crucial for stakeholders across pharmaceutical manufacturing, distribution channels, and clinical procurement. This comprehensive analysis explores the key manufacturers, authorized suppliers, and distribution networks associated with belumosudil mesylate.

Manufacturers and Developers of Belumosudil Mesylate

1. Kadmon Holdings, Inc.

Kadmon Holdings is the pioneering entity behind the development of belumosudil mesylate. Originally focusing on innovative therapies for immune and fibrotic diseases, Kadmon designed belumosudil to address unmet needs in post-transplant and hematologic patient populations. The drug received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2021 for the treatment of cGVHD after demonstrating promising efficacy and safety data in clinical trials [1].

2. Commercial Manufacturing Partners

Given the highly specialized synthesis and formulation requirements for kinase inhibitors, Kadmon contracts with third-party contract manufacturing organizations (CMOs) to produce belumosudil mesylate at scale. These partnerships ensure quality control, regulatory compliance, and capacity for global distribution. While specific manufacturing partners remain confidential or are protected under agreements, leading CMOs in the pharmaceutical industry with experience in small-molecule kinase inhibitors are involved. These may include established players such as Lonza, Catalent, or Samsung Biologics, depending on regional needs and manufacturing scope.

3. Licensing and Collaboration Agreements

In 2022, Kadmon entered strategic licensing arrangements with regional distributors and pharmaceutical companies to facilitate the distribution of belumosudil mesylate outside the United States. Such collaborations can involve local manufacturing licenses, supply chain management, and regulatory support. Notably, collaborations with regional entities in Europe, Asia, and Latin America expand access and ensure adherence to country-specific regulatory standards.

Authorized Suppliers and Distribution Channels

4. Global Distribution Networks

Rezlidhia (belumosudil mesylate) is supplied via specialized distribution networks that serve hospitals, Oncology and Hematology clinics, and specialty pharmacies. The drug’s distribution is tightly controlled due to its targeted indication and the need for cold chain management during transit. Major pharmaceutical logistics providers, such as McKesson Specialty Health, CVS Specialty, and regional distributors, handle the logistics and ensure timely delivery. These entities act as intermediaries between Kadmon and end-users, maintaining regulatory compliance and inventory management.

5. Regional Regulatory Approvals and Local Suppliers

In jurisdictions outside the U.S., the drug's availability depends on regional approvals and agreements with local suppliers. Kadmon’s licensing partners often designate regional manufacturers or authorized importers responsible for local distribution. For example, in the European Union, the drug’s distribution involves licensed entities compliant with EMA (European Medicines Agency) standards. Similarly, in Japan and China, local pharmaceutical importers authorized by Kadmon administer the supply chain.

6. Specialty Pharmacies and Clinical Supply Providers

In clinical contexts, drug supply is managed through specialized vendors like PAREXEL, BioScrip, and other clinical trial supply companies. These suppliers manage inventory, ensure cold chain stability, and facilitate timely delivery to research sites. During restricted access or compassionate use programs, these entities become primary sources of the drug.

Key Stakeholders and Supply Chain Dynamics

• Kadmon Holdings, Inc. (Developer, licensor, primary supplier licensee).
• Contract manufacturing organizations (CMOs).
• Regional licensing and distribution partners.
• Global logistics and cold chain providers.
• Regional regulatory agencies (e.g., FDA, EMA, PMDA).
• Specialty pharmacies and clinical trial suppliers.

Kadmon’s strategic partnerships and licensing agreements are crucial in ensuring broad and compliant access worldwide. The supply chain’s complexity underscores the importance of robust quality assurance, adherence to regulatory standards, and supply chain integrity.

Challenges and Considerations in the Supply of Belumosudil Mesylate

• Regulatory Hurdles: Variations in regional drug approvals affect supply timelines. Engagement with local authorities is essential for continuous authorization.
• Manufacturing Capacity: Kinase inhibitors require precise synthesis processes to maintain potency and purity. Scaling manufacturing without compromising quality remains a challenge.
• Supply Chain Security: Cold chain management and inventory control are critical, especially given the drug’s targeted therapeutic use. Disruptions can impact patient access.
• Market Competition: As more therapies emerge for related indications, manufacturing and supply strategies must adapt to meet competitive pressures.

Future Outlook and Supply Chain Optimization

Kadmon’s ongoing efforts to expand manufacturing capacity, streamline licensing agreements, and strengthen regional partnerships will shape the future supply of belumosudil mesylate. Technological innovations in synthesis and formulation could reduce production costs and lead times. Additionally, forming strategic alliances with global logistics firms will enhance supply resilience, ensuring consistent patient access worldwide.

Key Takeaways

• Kadmon Holdings is the primary developer and licensor of belumosudil mesylate, relying on contracted CMOs for manufacturing.
• Global distribution is managed through licensed partners, regional importers, and specialized logistics providers ensuring compliance and cold chain integrity.
• The drug’s supply chain faces challenges from regulatory variability, manufacturing complexities, and logistics demands, necessitating strategic management.
• Partnerships and licensing agreements are critical for expanding access, especially outside the U.S., where regional regulatory and market dynamics influence supply options.
• Future growth hinges on manufacturing advancements, regional licensing, and supply chain innovations to meet increasing demand.

FAQs

1. Who are the main manufacturers of belumosudil mesylate?
Kadmon Holdings, Inc. is the primary developer and licensor, with manufacturing outsourced to contract manufacturing organizations (CMOs) specializing in small-molecule kinase inhibitors. Specific CMO identities are typically confidential.

2. How is belumosudil mesylate distributed globally?
Distribution is managed through licensed regional partners, specialty pharmacies, and global logistics providers. Cold chain integrity and regulatory compliance are priorities throughout the supply chain.

3. Can I directly purchase belumosudil mesylate from the manufacturer?
Direct purchase by end-users is uncommon; procurement occurs through hospitals, specialty pharmacies, or clinical trial supply services authorized to handle the drug.

4. Are there regional differences in the supply of belumosudil mesylate?
Yes. Regional approvals, licensing agreements, and local manufacturing capabilities influence availability in specific countries or territories.

5. What are the future prospects for the supply of belumosudil mesylate?
Enhanced manufacturing capacity, expanded licensing agreements, and integrated supply chain optimization are expected to improve global access and reduce potential shortages.

Sources
[1] FDA Drug Approval Announcements, Kadmon’s Rezlidhia (belumosudil) approval details.