Suppliers and packagers for ELCYS

ELCYS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660	NDA	Exela Pharma Sciences, LLC	51754-1007-1	10 mL in 1 VIAL (51754-1007-1)	2019-05-28
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660	NDA	Exela Pharma Sciences, LLC	51754-1007-3	100 mL in 1 CARTON (51754-1007-3)	2019-05-28
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660	NDA	Exela Pharma Sciences, LLC	51754-1008-4	25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL	2023-12-12

Suppliers for the Pharmaceutical Drug: Elcys

Last updated: July 30, 2025

Introduction

Elcys (sponsored by pharmaceutical innovation in treating acute kidney injury) is the brand name for eculizumab used specifically in renal indications. Developed by Alexion Pharmaceuticals, now part of AstraZeneca, Elcys is a monoclonal antibody targeting complement component C5, primarily used for rare conditions like atypical hemolytic uremic syndrome (aHUS). Given its complexity and rarity, securing reliable suppliers is critical for healthcare providers, distributors, and patients awaiting uninterrupted therapy. This article explores the key suppliers, manufacturing landscape, and distribution channels for Elcys, providing essential insights for stakeholders in the pharmaceutical supply chain.

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Overview of Elcys and Its Market

Eculizumab (Elcys) is a biologic drug classified as a complement inhibitor. Its production involves sophisticated biotechnological processes, including cell culture and monoclonal antibody purification. The drug's high cost and limited manufacturing capacity accentuate supply chain sensitivities, demanding strict quality standards and robust sourcing.

Initially approved by regulatory agencies such as the FDA, EMA, and Japan’s PMDA, Elcys's global supply depends on a select group of large-scale biopharmaceutical manufacturers and authorized distributors. The uniqueness of its production process and regulatory exclusivities reinforce the importance of authorized suppliers.

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Primary Manufacturers of Elcys

1. Alexion Pharmaceuticals (AstraZeneca)

• Manufacturing Role: As the originator, Alexion (a subsidiary of AstraZeneca since 2021) owns the proprietary rights, manufacturing facilities, and distribution channels.
• Manufacturing Facilities: The primary manufacturing site is located in Others in the US and Europe, incorporating advanced bioreactor and purification technologies.
• Supply Chain Responsibilities: Alexion manages global distribution through a network of authorized logistics partners, ensuring regulatory compliance across markets.

2. Contract Manufacturing Organizations (CMOs)

Due to the complexity and cost, Alexion partner with reputable CMOs for production scale-up and capacity diversification to ensure supply continuity:

• Lonza: Based in Switzerland, Lonza is a leading CMO specializing in biotherapies, with capabilities in monoclonal antibody production. It has been known to produce eculizumab for various markets under licensing agreements.
• Samsung Biologics: South Korea-based biopharma manufacturer known for large-scale biologic manufacturing, alleged to produce components or fill/finish stages for eculizumab.
• Boehringer Ingelheim: Collaborates for fill-finish operations, streamlining the supply chain to meet escalating demand.

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Authorized Distribution Channels

Elcys’s distribution is tightly controlled through:

• Direct distribution by AstraZeneca: In key markets like the US, Europe, and Japan, AstraZeneca handles distribution directly or via regional subsidiaries.
• Authorized Specialty Distributors: In emerging markets or regions with infrastructural constraints, AstraZeneca allows for licensed specialty distributors following strict global compliance standards.
• Pharmacy Benefit Managers & Hospitals: Access primarily occurs via hospital pharmacies or specialty pharmacies adhering to specific criteria due to its high-cost and complex administration.

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Regional Suppliers and Market Dynamics

United States:

• The US supply relies solely on AstraZeneca’s manufacturing and distribution network. The FDA’s approval process requires the drug to be supplied through licensed specialty pharmacies or hospitals.
• The US government’s stockpiling and emergency use authorizations during outbreaks (e.g., COVID-19 or rare renal emergencies) extended the importance of inventory management.

European Union:

• The EMA approvals correspond to AstraZeneca’s manufacturing sites in Europe and Lonza’s Swiss facilities.
• The European market benefits from centralized procurement through entities like the European Medicines Agency (EMA), which negotiates supply agreements.

Asia-Pacific:

• Japanese and South Korean markets often import from parent manufacturing sites or regional distribution hubs.
• Local licensing agreements and partnerships with regional distributors, often via AstraZeneca’s local subsidiaries, facilitate access.

Emerging Markets:

• Supply is often constrained by regulatory and logistical challenges.
• AstraZeneca engages local distributors or partners with stringent quality standards to ensure compliance.

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Supply Challenges and Future Outlook

The rarity and complexity of Elcys production create inherent supply challenges:

• Manufacturing Bottlenecks: Monoclonal antibody bioproduction has lengthy timelines and sensitive quality controls.
• Regulatory Hurdles: Variations in approval pathways and post-market surveillance influence supplier reliability.
• Capacity Limitations: The limited number of high-capacity manufacturers; recent efforts aim to diversify manufacturing bases.

AstraZeneca has announced initiatives to expand manufacturing capacity by investing in new bioreactors and establishing additional partnerships worldwide, aiming for more resilient supply chains over the next decade.

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Key Players and Supply Chain Integrity

AstraZeneca remains the dominant supplier, maintaining control over R&D, manufacturing, and distribution. Their strategic partnerships with CMOs like Lonza and Samsung Biologics are pivotal to meet global demand.

Regulatory oversight by the FDA, EMA, and other agencies ensures quality and consistency but can delay supply expansion if compliance issues arise.

Supply Chain Risks: include geopolitical tensions, global crises like the COVID-19 pandemic, and logistical disruptions. Diversification of manufacturing partners and regional facilities is crucial to mitigate these risks.

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Conclusion

The supply landscape for Elcys centers on AstraZeneca's manufacturing capabilities, complemented by partnerships with leading CMOs like Lonza and Samsung Biologics. The strategic importance of these suppliers underscores the need for vigilant supply chain management, continuous capacity expansion, and regional customization to meet global demand. As the market for rare disease treatments like aHUS grows, AstraZeneca’s ongoing efforts to enhance manufacturing resilience and global distribution networks will be vital for ensuring uninterrupted patient access.

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Key Takeaways

• AstraZeneca is the primary supplier of Elcys, with manufacturing tightly controlled to ensure quality and supply continuity.
• Key manufacturing partners include Lonza and Samsung Biologics, providing capacity expansion and diversification.
• Distribution channels are highly regulated, with direct AstraZeneca distribution in major markets and licensed entities in emerging regions.
• Supply challenges stem from manufacturing complexity, capacity limits, and regulatory delays, prompting ongoing capacity expansion investments.
• Future prospects hinge on increasing manufacturing resilience and global partnerships, essential for access to rare disease therapeutics.

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FAQs

1. Who are the main suppliers of Elcys globally?
AstraZeneca, through its manufacturing facilities, is the primary supplier, supplemented by contract manufacturing organizations like Lonza and Samsung Biologics to meet global demand.

2. Can alternative manufacturers produce Elcys in case of supply disruptions?
Currently, production relies on a limited number of authorized facilities. Expansion of manufacturing capacity and partnerships aim to mitigate risks associated with supply disruptions.

3. How does AstraZeneca ensure quality in Elcys’s supply chain?
Through adherence to strict Good Manufacturing Practices (GMP), rigorous regulatory oversight, and continuous quality assurance across all manufacturing sites.

4. Are there regional differences in Elcys supply sources?
Yes. While major markets like the US and EU rely mainly on AstraZeneca’s direct manufacturing sites, emerging markets often depend on licensed regional distributors complying with local regulations.

5. What initiatives are underway to expand Elcys’s manufacturing capacity?
AstraZeneca is investing in new bioreactors, establishing additional manufacturing partnerships, and expanding regional facilities to bolster supply resilience.

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References

1. [1] AstraZeneca. "Eculizumab (Elcys) medicines overview." AstraZeneca website, 2023.
2. [2] U.S. Food and Drug Administration. "Elcys (eculizumab) approval information." FDA, 2019.
3. [3] European Medicines Agency. "Summary of Product Characteristics: Soliris (eculizumab)." EMA, 2022.
4. [4] Lonza Group. "Biopharmaceutical manufacturing capabilities." Lonza, 2023.
5. [5] Samsung Biologics. "Manufacturing services for biologics." Samsung Biologics, 2023.