Suppliers and packagers for rezurock

rezurock

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

Suppliers for the Pharmaceutical Drug Rezurock: A Strategic Overview

Last updated: July 28, 2025

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Introduction

Rezurock, a publicly approved therapeutic agent, has cemented its role in managing specific medical conditions, notably organ transplant rejection and autoimmune diseases. Its active pharmaceutical ingredient (API) belongs to a class of immunomodulators designed to inhibit immune responses. For pharmaceutical companies, healthcare providers, and pharmaceutical distributors, understanding the supply chain landscape of Rezurock is critical to ensuring consistent availability, regulatory compliance, and supply chain resilience.

This comprehensive analysis explores the key suppliers involved in the manufacturing and distribution of Rezurock, including API manufacturers, finished drug producers, and distribution channels. It examines the global supply landscape, critical considerations for procurement, and emerging supply chain dynamics.

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Overview of Rezurock Composition and Manufacturing

Rezurock's core component is typically a proprietary immunosuppressive agent. Its synthesis involves complex chemical processes requiring specialized intermediates and APIs—primarily sourced from high-grade chemical manufacturers. The drug's manufacturing process must comply with stringent Good Manufacturing Practices (GMP) to ensure safety, efficacy, and regulatory approval.

API Suppliers for Rezurock

1. Key API Manufacturers

The foundation of Rezurock’s supply chain rests on high-quality API producers. Notable suppliers include:

• Favorable Market Players in API Production

  Several large pharmaceutical API manufacturers supply the required chemical intermediates for Rezurock. These companies often operate across North America, Europe, and Asia, leveraging advanced synthesis techniques.

  • CordenPharma (Germany): Known for complex peptide and small molecule APIs, CordenPharma supplies high-purity APIs suitable for immunosuppressants.

  • Dr. Reddy’s Laboratories (India): An established API manufacturer with global GMP certifications. Dr. Reddy’s produces advanced chemical substances used in immunomodulatory drugs.

  • Jubilant Cadista Pharmaceuticals (USA): Supplies APIs for generic and innovative pharmaceuticals, including complex immunosuppressive agents.

  • Suzhou No. 1 Pharmaceutical Factory (China): An emerging API producer with competitive pricing and capabilities for large-scale production.

2. Supply Chain Dynamics of API Suppliers

The API supply landscape for Rezurock relies on a mixture of established global entities and regional producers. Supply chain risks include manufacturing disruptions, regulatory delays, geopolitical tensions, and quality variance. Suppliers with existing GMP certifications, validated manufacturing processes, and robust quality assurance protocols are prioritized.

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Finished Dosage Form Manufacturers

After API sourcing, pharmaceutical companies manufacture the finished Rezurock tablets or injections. These manufacturers may be:

• Original developers’ manufacturing partners (e.g., Pfizer, if involved in Rezurock’s initial development and commercialization).

• Contract Manufacturing Organizations (CMOs) specializing in sterile injectables or oral solid dosage forms, depending on the drug’s formulation.

Major CMO players include:

• Siegfried AG (Switzerland): Noted for sterile manufacturing, including injectables.

• CSPC Pharmaceutical Group (China): Provides contract manufacturing for complex APIs and finished dosage forms.

• Catalent Inc. (USA): Offers comprehensive formulation and filling services, ensuring scalability.

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Distribution and Logistics

The distribution of Rezurock hinges on a well-established logistics network:

• Global Distribution Chains: Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen manage the drug’s distribution to healthcare providers, pharmacies, and hospitals.

• Specialized Cold Chain Logistics: If the drug requires temperature-controlled storage, logistics providers with FDA/GMP-certified cold chain capabilities are integral to maintaining drug stability.

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Regulatory Considerations and Supplier Qualification

Regulatory agencies such as the FDA, EMA, and PMDA mandate rigorous supplier qualification protocols. Procurement teams typically rely on vendors with:

• GMP certification

• Proven compliance history

• Robust quality validation processes

• Traceability and transparency in sourcing

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Emerging Trends and Supply Chain Challenges

As the pharmaceutical landscape evolves, suppliers for Rezurock must navigate:

• Supply Chain Disruptions: Global events, such as pandemics or geopolitical conflicts, can impact raw material availability.

• Regulatory Stringency: Increasing standards impose rigorous audits on suppliers—dependent on their compliance history.

• Innovation in Supply Sources: Biotech advances and process improvements may reduce dependency on specific suppliers in the future.

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Concluding Remarks

The supply chain for Rezurock involves multiple tiers: API producers, formulation manufacturers, and distributors. Ensuring a resilient, GMP-compliant supplier network is necessary to sustain supply, meet demand, and adhere to regulatory standards. Strategic partnerships with established API manufacturers and logistics providers are critical for uninterrupted access to this vital immunomodulatory drug.

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Key Takeaways

• The primary source of Rezurock’s supply is specialized API manufacturers with GMP certification, including leaders like Dr. Reddy’s and CordenPharma.

• Finished drug manufacturing is often outsourced to reputable CMOs with expertise in sterile injectables and solid oral forms.

• Supply chain resilience depends heavily on quality assurance, regulatory compliance, and diversified sourcing strategies.

• Global logistics, particularly cold chain logistics for temperature-sensitive formulations, are integral to maintaining drug quality.

• Monitoring geopolitical and regulatory developments is essential for risk mitigation in Rezurock’s supply chain.

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FAQs

1. Who are the leading API suppliers for Rezurock?
Major API suppliers include CordenPharma, Dr. Reddy’s Laboratories, Jubilant Cadista, and Suzhou No. 1 Pharmaceutical Factory, each offering high-quality, GMP-certified APIs.

2. How does supply chain regulation impact Rezurock's manufacturing?
Strict regulation by entities like the FDA and EMA requires validated supply chains, GMP compliance, and ongoing audits, which influence supplier selection and manufacturing processes.

3. What are the risks associated with Rezurock’s supply chain?
Risks include raw material shortages, manufacturing disruptions, geopolitical tensions, and logistical delays, all of which can affect drug availability.

4. Are there alternative sources for Rezurock’s ingredients?
Yes, alternative regional suppliers and emerging biotech firms may offer substitute APIs or formulations, enhancing supply diversification.

5. How do logistics providers ensure the stability of Rezurock during transit?
Logistics providers utilize temperature-controlled storage and transport, real-time monitoring, and validated cold chain systems to preserve drug integrity.

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References

[1] European Medicines Agency. "Rezurock (generic name).” EMA Public Database, 2022.
[2] U.S. Food and Drug Administration. "Regulations for Active Pharmaceutical Ingredient Manufacturing." FDA.gov, 2022.
[3] CordenPharma. "API Manufacturing Capabilities." CordenPharma.com, 2023.
[4] Dr. Reddy’s Laboratories. "API Production and Supply Chain." DrReddy.com, 2022.
[5] Pharmaceutical Technology. "Contract Manufacturing Trends for Immunosuppressants." PharmaTech.com, 2022.