Adalimumab Pen Suppliers & Bulk Manufacturers
Available Forms: Pre-filled Syringe or Pen
Available Strengths: 40 mg/0.8 mL, 40 mg/0.4 mL
Reference Brands: Humira (US & EU)
Category:
Arthritis
Adalimumab is a monoclonal antibody that binds to TNF-alpha, a cytokine involved in inflammation and immune response. It reduces inflammation, tissue damage, and symptoms in rheumatoid arthritis. Benefits include rapid symptom relief, improved joint function, reduced disease progression, and convenient subcutaneous administration, enhancing patient adherence and quality of life.
Adalimumab pen is available in Pre-filled Syringe or Pen
and strengths such as 40 mg/0.8 mL, 40 mg/0.4 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, Adalimumab pen 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) |
Adalimumab pen 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.
Product Description:
Adalimumab pen is approved in the EU and US for rheumatoid arthritis and other autoimmune diseases. In the EU, brands like Humira are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on extensive clinical data, biosimilarity assessments, and pharmacovigilance. Both regions require detailed dossiers for approval and continued safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for adalimumab pens, ensuring adherence to European and American standards for safe, effective biologic therapy, and helping you navigate complex regulatory processes seamlessly.
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