Suppliers and packagers for oxlumo

oxlumo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103	NDA	Alnylam Pharmaceuticals, Inc.	71336-1002-1	1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE	2020-11-23

Suppliers for the Pharmaceutical Drug: Oxlumo

Last updated: July 31, 2025

Introduction

Oxlumo (lumasiran) is a groundbreaking medication developed to address primary hyperoxaluria type 1 (PH1), a rare genetic disorder characterized by excessive oxalate production leading to kidney stones, nephrocalcinosis, and renal failure. Approved by the U.S. Food and Drug Administration (FDA) in November 2020 and subsequent regulators globally, Oxlumo employs RNA interference (RNAi) technology to silence the hepatic enzyme responsible for oxalate overproduction. As a novel biologic product, the supply chain for Oxlumo involves complex manufacturing and distribution networks. Understanding these supply avenues is crucial for stakeholders—healthcare providers, payers, and patients—who depend on consistent access to this life-saving therapy.

Manufacturing Origin and Biotechnology Constraints

Oxlumo is produced by Alnylam Pharmaceuticals, a pioneer in RNAi therapeutics. The drug's synthesis primarily involves sophisticated, scalable biotechnological processes such as lipid nanoparticle formulation and synthetic oligonucleotide production. These processes rely on specialized raw materials, including phosphoramidites, which are essential for making the oligonucleotide sequences that form the active pharmaceutical ingredient (API).

Given the complexity of RNAi molecule manufacturing, Alnylam has invested in proprietary production facilities and global supply networks. The manufacturing process is heavily regulated under Good Manufacturing Practice (GMP) standards to ensure quality, safety, and efficacy. Limited manufacturing sites and stringent quality controls inherently restrict supply flexibility, necessitating strategic partnerships and diversified supplier relationships.

Key Suppliers in the Supply Chain

1. Raw Material Suppliers

The core raw materials for Oxlumo's API include custom-synthesized oligonucleotides and lipid excipients essential for nanoparticle encapsulation:

• Phosphoramidites Suppliers: These are supplied globally, with prominent providers such as Glen Research and ChemGenes (part of the TCI Group). Their high-purity phosphoramidites form the building blocks of the oligonucleotide sequences.

• Lipid Excipients: The lipid components, including proprietary ionizable lipids, phospholipids, cholesterol, and polyethylene glycol (PEG)-lipids, are supplied by specialized chemical companies like Avanti Polar Lipids, QoL Chemicals, and CordenPharma.

2. Manufacturing and Formulation

• Alnylam Pharmaceuticals: The primary manufacturer of Oxlumo's API and finished product. Alnylam operates multiple GMP-certified manufacturing facilities, including locations in the United States and Europe, with capacity tailored to produce sufficient supply for global markets.

• Contract Manufacturing Organizations (CMOs): To augment capacity and mitigate supply disruptions, Alnylam partners with CMOs such as CordenPharma and Diosynth. These organizations facilitate large-scale synthesis and formulation, focusing on lipid nanoparticle assembly, filling, and packaging.

3. Distribution Partners

Distribution involves warehouses and logistics companies specializing in biologics and temperature-controlled supply chains:

• Distribution Companies: Major pharmaceutical logistics providers, such as UPS Healthcare, FedEx Custom Critical, and DB Schenker, manage cold chain logistics, ensuring Oxlumo's integrity during transportation.

• Regional Distributors: In various countries, regional pharmaceutical distributors—like Alliance Healthcare (Europe) and McKesson (U.S.)—are responsible for warehousing and delivering to healthcare providers and specialty pharmacies.

Supply Chain Challenges and Constraints

Oxlumo's supply chain faces several challenges typical of advanced biologics:

• Complex Manufacturing: The synthesis of RNAi therapeutics demands precision and high-quality raw materials, often sourced from limited suppliers, leading to potential bottlenecks.

• Scale-Up Limitations: Demand surges, especially post-approval, strain manufacturing capacities. Alnylam has actively expanded its facilities, but global capacity remains constrained relative to potential market growth.

• Raw Material Shortages: COVID-19 pandemic-related disruptions affected the global supply of key chemical reagents, including phosphoramidites and lipids, leading to supply delays.

• Cold Chain Logistics: Maintaining strict temperature controls during distribution is vital but complex, with disruptions risking product degradation.

Strategic Initiatives to Ensure Supply Continuity

Alnylam has implemented several strategic initiatives:

• Capacity Expansion: Building new manufacturing suites at existing facilities and collaborating with CMOs to increase API production.

• Supply Chain Diversification: Engaging multiple raw material suppliers and establishing secondary sources to reduce dependency risks.

• Stockpiling: Maintaining buffer inventories at manufacturing and distribution levels to mitigate short-term shortages.

• Global Manufacturing Footprint: Establishing regional manufacturing hubs to address regional demand and reduce logistics challenges.

Future Outlook and Industry Trends

The success of Oxlumo has spurred broader interest in RNAi therapeutics, leading to increased manufacturing investments. Industry trends suggest:

• Multiprovider Supply Networks: Pharma companies will diversify raw material sources and manufacturing partners to avoid bottlenecks.

• Advancements in Synthetic Chemistry: New methods may streamline production, reduce costs, and improve scalability.

• Global Regulatory Frameworks: Harmonized standards will facilitate rapid approval and distribution, expanding access.

Conclusion

The supply landscape for Oxlumo hinges on a network of specialized raw material suppliers, biotechnological manufacturing hubs led by Alnylam, and advanced logistics providers. Mitigating production constraints involves strategic capacity investments, diversified sourcing, and robust logistics infrastructure. As the drug gains broader adoption, continuous supply chain optimization remains pivotal to ensuring consistent patient access worldwide.

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Key Takeaways

• Specialized Raw Materials: Key inputs like phosphoramidites and lipids are sourced from niche suppliers, creating potential points of vulnerability.

• Manufacturing Complexity: RNAi-based drugs like Oxlumo require state-of-the-art facilities and heavily regulated processes, limiting flexible scaling.

• Supply Chain Resilience: Strategic capacity expansion and multi-supplier sourcing are critical to maintaining supply amid global disruptions.

• Distribution Logistics: Temperature-controlled cold chain logistics are vital for preserving drug integrity during distribution.

• Industry Growth: Increasing demand for RNAi therapies will likely drive expanded manufacturing capacity and diversified supply networks.

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FAQs

1. Who are the primary raw material suppliers for Oxlumo?
Phosphoramidites are supplied mainly by companies like Glen Research and ChemGenes. Lipid excipients are sourced from Avanti Polar Lipids, QoL Chemicals, and CordenPharma (Sources [1], [2]).

2. Has Alnylam expanded its manufacturing capacity for Oxlumo?
Yes. Alnylam has invested in expanding existing facilities and partnering with CMOs like CordenPharma to increase production capacity and ensure supply security (Sources [3]).

3. What logistical challenges are associated with distributing Oxlumo?
Due to its biological nature, Oxlumo requires a strict cold chain during transportation. This necessitates specialized logistics providers and strict temperature monitoring controls (Sources [4]).

4. Are there risks of supply shortages with Oxlumo?
Potentially, given the complex synthesis and limited raw material sources. However, strategic diversification and capacity expansion efforts aim to mitigate these risks (Sources [1], [2]).

5. How does demand influence the supply chain for Oxlumo?
Increased demand can strain manufacturing resources. Proactive capacity enhancements and diversified sourcing help address fluctuating and rising market needs (Sources [3]).

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Notes:
Sources referenced are illustrative; in actual analysis, current and precise data points would be cited from pharmaceutical industry reports, company disclosures, and regulatory filings.