Suppliers and packagers for generic pharmaceutical drug: LUMASIRAN SODIUM

LUMASIRAN SODIUM

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: LUMASIRAN SODIUM

Last updated: July 27, 2025

Introduction

Lumasiran sodium, marketed under the brand name Oxlumo, is a groundbreaking RNA interference (RNAi) therapeutic approved for the treatment of primary hyperoxaluria type 1 (PH1). This rare genetic disorder results in the overproduction of oxalate, leading to kidney stones, renal failure, and systemic oxalosis. Since its approval by the FDA in November 2020, Lumasiran sodium has garnered significant attention within the pharmaceutical and biotech sectors for its innovative mechanism and targeted approach. Consequently, identifying reliable suppliers of Lumasiran sodium is crucial for healthcare providers, pharmaceutical companies, and distributors aiming to ensure a steady, high-quality supply chain.

Manufacturers and Technology Originators

Alnylam Pharmaceuticals Inc., headquartered in Cambridge, Massachusetts, developed Lumasiran sodium as part of their advanced RNAi therapeutic portfolio. Their proprietary platform technology, known as Alnylam 5x19, facilitated the design and synthesis of Lumasiran, targeting hepatocyte-specific delivery of siRNA molecules. Alnylam retains full manufacturing rights and is the primary producer, ensuring control over quality, regulatory compliance, and supply integrity.

Manufacturing Facilities
Alnylam’s manufacturing of Lumasiran sodium involves GMP-compliant facilities, often located in North America and Europe. These facilities are equipped with state-of-the-art bioprocessing capabilities designed for complex oligonucleotide synthesis, purification, and formulation.

Global Suppliers and Distributors

1. Alnylam Pharmaceuticals Inc.

As the originator, Alnylam is the primary supplier of Lumasiran sodium. The company’s global distribution network ensures availability across North America, Europe, and select markets in Asia. They operate through a combination of direct sales and authorized distributors specializing in rare disease therapeutics.

2. Authorized Distributors and Wholesalers

In regions where regional distribution is regulated or where direct sourcing from Alnylam isn’t feasible, licensed pharmaceutical wholesalers serve as secondary suppliers. These companies hold distribution rights granted by Alnylam, maintaining strict compliance with storage and handling standards for biologics and RNAi therapies.

Prominent distributors include:

• McKesson Corporation
• AmerisourceBergen Corporation
• Cardinal Health

These entities facilitate the transportation and inventory management of Lumasiran sodium in North America.

3. Regional and Local Suppliers

In select countries, regional biotech companies or licensed pharmacies might acquire Lumasiran sodium through authorized channels for hospital use, especially in markets where Alnylam has local partnerships or authorized importers.

Supply Chain Challenges and Considerations

• Special Handling Requirements: Lumasiran sodium’s complex biological nature necessitates stringent cold chain logistics, with storage temperatures typically maintained at -20°C or lower.
• Limited Production Capacity: As a specialized biologic, manufacturing capacity is finite and prioritized for approved markets, which may lead to supply constraints.
• Regulatory Approvals: Suppliers must adhere to local regulatory requirements, including licensing, importation, and distribution approvals, potentially impacting availability in certain regions.

Emerging and Contract Manufacturing Partnerships

While Alnylam maintains direct control over primary manufacturing, there are ongoing collaborations with contract manufacturing organizations (CMOs) to expand capacity and support global distribution efforts. These CMOs often operate under strict confidentiality and quality agreement clauses.

Future Supply Dynamics

Alnylam’s strategic investments in expanding manufacturing capacity, including potential new facilities, are expected to mitigate supply constraints. Additionally, their emphasis on quality control and regulatory compliance aims to reassure stakeholders of the safety and reliability of supply.

Market and Competitive Landscape

Alternatives to Lumasiran sodium are under clinical development, such as Ortuma (Lumasiran’s competitors or adjunct therapies), but none have yet compromised the primary supplier dominance. As the RNAi platform matures, multiple suppliers may emerge, increasing competition and supply diversity.

Key Takeaways

• Primary Supplier: Alnylam Pharmaceuticals is the sole developer and primary producer of Lumasiran sodium, with extensive global distribution channels.
• Distribution Partners: Major pharmaceutical wholesalers like McKesson, AmerisourceBergen, and Cardinal Health serve as secondary suppliers, ensuring access across regions.
• Supply Chain Integrity: The complex biological nature requires cold chain logistics and strict handling procedures, which challenge consistent supply.
• Capacity Expansion: Ongoing investments in manufacturing capacity by Alnylam are essential to meet increasing demand.
• Regulatory Impact: Compliance with regional regulatory frameworks remains critical for supplier operation and drug availability.

FAQs

1. Who are the main suppliers of Lumasiran sodium globally?
Alnylam Pharmaceuticals Inc. remains the primary supplier, supported by authorized regional distributors and major pharmaceutical wholesalers like McKesson, AmerisourceBergen, and Cardinal Health.

2. Can other manufacturers produce Lumasiran sodium?
Currently, Alnylam retains exclusive manufacturing rights. Although contract manufacturing organizations support capacity expansion, no third-party producers are authorized for commercial sale without Alnylam’s direct involvement.

3. What are the logistical challenges involved in supplying Lumasiran sodium?
Its biological complexity necessitates strict cold-chain logistics, maintaining storage temperatures around -20°C. This requirement adds complexity and cost to global distribution.

4. Are there any regional restrictions on Lumasiran sodium supply?
Yes. Regulatory approvals, import restrictions, and regional licensing influence supply availability, with some markets relying on direct imports and authorized local distributors.

5. What is the outlook for future supply of Lumasiran sodium?
Alnylam’s ongoing capacity expansion and strategic partnerships aim to stabilize and increase supply, ensuring broader access as the drug’s adoption grows.

References

1. FDA Approval of Oxlumo (Lumasiran). U.S. Food and Drug Administration. (2020).
2. Alnylam Pharmaceuticals Official Website. Product information and manufacturing details.
3. Global Supply Chain Considerations for Biologics. Journal of Pharmaceutical Sciences, 2021.
4. Market Analysis of Rare Disease Therapeutics. IQVIA Reports, 2022.
5. Regulatory Landscape for RNAi Therapeutics. European Medicines Agency, 2022.

Note: Data references are illustrative. For actual supply chain details, consulting directly with Alnylam or authorized distributors is recommended.