Product/Composition:- | Adalimumab pen |
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Strength:- | 40 mg/0.8 mL, 40 mg/0.4 mL |
Form:- | Pre-filled Syringe or Pen |
Reference Brands:- | Humira (US & EU) |
MOQ | As per the manufacturer batch size |
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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 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.