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Dupilumab bulk supplier for pharma manufacturers

Dupilumab Suppliers & Bulk Manufacturers

Available Forms: injection (prefilled syringe/ Prefilled Pen)

Available Strengths: 200 mg/1.14 mL, 300 mg/2 mL

Reference Brands: Dupixent (USA)

Category: Immune Disorder

Dupilumab is a fully human monoclonal antibody that targets the interleukin-4 receptor alpha (IL-4Rα), blocking the signaling of IL-4 and IL-13, key cytokines involved in type 2 inflammation. By modulating this immune pathway, Dupilumab helps control chronic immune-mediated conditions. Dupilumab is available in injection (prefilled syringe/ Prefilled Pen) and strengths such as 200 mg/1.14 mL, 300 mg/2 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, Dupilumab 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)

Dupilumab 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:

Dupilumab, marketed under the brand name Dupixent, is a fully human monoclonal antibody that targets the interleukin-4 receptor alpha (IL-4Rα), thereby blocking IL-4 and IL-13 receptor signaling. These cytokines are central drivers of type 2 inflammation, which plays a key role in several chronic allergic and inflammatory conditions.

Dupilumab is approved for the treatment of moderate-to-severe atopic dermatitis (eczema), asthma, and chronic rhinosinusitis with nasal polyps. It is also indicated for other type 2 inflammatory disorders, including eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD). By inhibiting IL-4 and IL-13 signaling, dupilumab reduces inflammation, alleviates symptoms, improves skin and respiratory function, and enhances quality of life for patients with these conditions.

The medication is administered as a subcutaneous injection, typically every two weeks, with dosing adjusted based on the patient’s condition and weight. Clinical studies have demonstrated significant improvement in disease severity, symptom control, and long-term safety, making dupilumab an important therapeutic option for patients with type 2 inflammatory diseases.

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Frequently Asked Questions

Dupilumab is used to treat conditions driven by type 2 inflammation, including moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. It helps reduce inflammation, improve symptoms, and enhance quality of life in patients with these chronic conditions.

Dupilumab is a fully human monoclonal antibody produced using recombinant DNA technology. It targets the interleukin-4 receptor alpha (IL-4Rα) subunit, inhibiting IL-4 and IL-13 signaling pathways involved in type 2 inflammatory responses.

The main trade name for dupilumab is Dupixent.

Dupilumab (Dupixent) is manufactured by Regeneron Pharmaceuticals in collaboration with Sanofi.

The generic name is Dupilumab.

The brand name is Dupixent.

Dupilumab is manufactured in the United States and distributed globally, including the EU, Japan, India, and other international markets.

Yes, Dupilumab 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, Dupilumab 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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