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Lumasiran Sodium bulk supplier for pharma manufacturers

Lumasiran Sodium Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 94.5 mg/0.5 mL

Reference Brands: Oxlumo (USA)

Category: Orphan Drugs

Lumasiran Sodium is available in Injection and strengths such as 94.5 mg/0.5 mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Lumasiran Sodium is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Lumasiran Sodium can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Lumasiran is a double-stranded small interfering ribonucleic acid (siRNA) therapeutic developed to treat primary hyperoxaluria type 1 (PH1) by directly addressing the metabolic pathway responsible for excessive oxalate production. It works through RNA interference by specifically targeting the hydroxyacid oxidase 1 (HAO1) messenger RNA in hepatocytes. This action leads to a reduction in the production of the glycolate oxidase (GO) enzyme in the liver.

Lower levels of glycolate oxidase result in decreased conversion of glycolate to glyoxylate, which is a key precursor in the formation of oxalate. By reducing the availability of glyoxylate, lumasiran significantly lowers urinary and plasma oxalate levels, thereby addressing the underlying cause of disease manifestations in patients with PH1, including kidney stone formation and progressive renal damage.

Importantly, the mechanism of action of lumasiran is independent of the specific AGXT gene mutation responsible for PH1. Because glycolate oxidase functions upstream of the deficient alanine:glyoxylate aminotransferase (AGT) enzyme, lumasiran is effective across different genetic variants of the disease. This targeted, gene-silencing approach represents a disease-modifying strategy and a major advancement in the management of primary hyperoxaluria type 1.

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Frequently Asked Questions

Lumasiran sodium is used for the treatment of primary hyperoxaluria type 1 (PH1), a rare inherited metabolic disorder that leads to excessive oxalate production, recurrent kidney stones, nephrocalcinosis, and progressive kidney failure. It is indicated for both pediatric and adult patients to reduce urinary and plasma oxalate levels.

Lumasiran sodium is a synthetic small interfering RNA (siRNA) molecule. It is designed using RNA interference technology to specifically target and silence the HAO1 gene in the liver, which encodes the glycolate oxidase enzyme involved in oxalate production.

The trade name of lumasiran sodium is Oxlumo.

Lumasiran sodium (Oxlumo) is developed and marketed by Alnylam Pharmaceuticals, a biotechnology company specializing in RNA interference–based therapies.

The generic name is lumasiran sodium.

The brand name is Oxlumo.

Lumasiran sodium is manufactured by Alnylam Pharmaceuticals through specialized biopharmaceutical manufacturing facilities in the United States and Europe, in compliance with global regulatory standards for advanced RNA-based therapies.

Yes, Lumasiran Sodium is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Lumasiran Sodium is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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