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: February 19, 2026

Who are the primary suppliers of lumasiran sodium?

Lumasiran sodium is marketed primarily by Alnylam Pharmaceuticals under the brand name Oxlumo. It is a recently approved RNA interference (RNAi) therapeutic used to treat primary hyperoxaluria type 1 (PH1). The production chain includes synthesis of the active pharmaceutical ingredient (API), formulation, and distribution.

API Manufacturing and Supply Chain

Manufacturers of Lumasiran Sodium API

Lumasiran sodium is a synthetic RNA molecule that requires specific chemical synthesis, stabilization, and formulation.

Manufacturer	Role	Location	Notes
Alnylam Pharmaceuticals	Developer and sole API producer	USA	Has proprietary manufacturing facilities for the API.
Custom synthesis firms (e.g., Array BioPharma, GenScript, Biosynthesis)	Contract manufacturing organizations (CMOs)	Various	May produce intermediates or supply bulk API under contract, but specific partnerships are not publicly disclosed.

API Production Capacity & Limitations

• Alnylam's API production capacity is limited by the complexity of RNA synthesis and formulation processes.
• Raw material availability, such as nucleotides and phosphoramidite reagents, can limit production scaling.
• Regulatory constraints and quality standards impact manufacturing throughput.

Formulation and Final Product Supply

• Alnylam manages formulation, filling, and packaging in-house or via authorized contract manufacturers.
• Distribution is direct to hospitals and specialty pharmacies globally, with primary markets in the U.S. and Europe.

Contract Manufacturing & Supply Agreements

• To secure a consistent supply, Alnylam maintains exclusive agreements predominantly with specialized CMOs.
• Long-term supply agreements are typical in RNAi therapeutics to ensure large-scale distribution.

Distributors and Logistics

• Logistics providers include global freight carriers specializing in cold chain management, critical for RNAi drugs.
• Distributors interface with hospitals, clinics, and pharmacies to deliver Oxlumo.

Market Competition and Supply Risks

• Currently, Alnylam holds exclusive rights over lumasiran sodium.
• Market entry barriers for competitors include complex synthesis, proprietary formulations, and regulatory approvals.
• Supply chain risks include raw material shortages, manufacturing delays, or regulatory changes impacting production.

Summary of Key Suppliers and Stakeholders

Stakeholder	Role	Location	Notes
Alnylam Pharmaceuticals	Sole API producer, marketer	USA	Manages manufacturing, formulation, distribution.
Contract synthesis firms	CMOs	Various	Possible production of intermediates or bulk API.
Logistics providers	Cold chain logistics	Global	Ensures stability during distribution.

Closing notes

Lumasiran sodium's supply hinges on Alnylam's manufacturing and contractual relationships. The company's control over the API development and production process creates barriers for new entrants. Supply chain robustness depends on raw material availability, manufacturing capacity, and logistics.

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Key Takeaways

• Alnylam Pharmaceuticals is the primary and likely sole producer of lumasiran sodium API and final formulations.
• Contract manufacturers and logistics providers support scaling and distribution.
• Supply chain stability depends on raw material procurement, manufacturing capacity, and regulatory consistency.
• Market concentration reduces competition but elevates risk for supply disruptions.
• Entry barriers for competitors include complex synthesis, proprietary formulations, and regulatory approval hurdles.

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FAQs

1. Who are the main suppliers of lumasiran sodium?
   Alnylam Pharmaceuticals is the primary supplier, handling API synthesis, formulation, and distribution.

2. Are there any known contract manufacturers for lumasiran sodium?
   Yes, various CMOs may be involved in intermediate or bulk API production, but specifics are confidential.

3. What are the primary risks to lumasiran sodium's supply chain?
   Raw material shortages, manufacturing delays, regulatory changes, and logistical disruptions.

4. Can new competitors enter the market for lumasiran sodium?
   Market barriers include complex RNA synthesis, proprietary technology, and regulatory approval processes.

5. What are the key logistical considerations for distributing lumasiran sodium?
   Cold chain management is critical due to the RNA-based formulation's temperature sensitivity.

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References

1. Alnylam Pharmaceuticals. (2023). Oxlumo (lumasiran) prescribing information. [FDA website]
2. U.S. Food and Drug Administration. (2020). Approval letter for Oxlumo.
3. European Medicines Agency. (2021). EMA approval for Oxlumo.
4. Johnson, et al. (2022). RNAi Therapeutics Manufacturing Processes. Journal of Pharmaceutical Science.
5. GlobalData. (2023). RNAi Therapeutics Market Report.