Etanercept Pen Suppliers & Bulk Manufacturers
Available Forms: Pre-filled Syringe or Pen
Available Strengths: 50 mg/0.5 mL, 50 mg/1 mL
Reference Brands: Enbrel (US & EU)
Category: Arthritis
Etanercept is a recombinant fusion protein that binds to TNF-alpha, blocking its inflammatory effects. It reduces joint inflammation, pain, and tissue damage in rheumatoid arthritis. Benefits include rapid symptom relief, improved joint function, disease progression slowing, and convenient subcutaneous administration, enhancing patient adherence and quality of life. Etanercept Pen is available in Pre-filled Syringe or Pen and strengths such as 50 mg/0.5 mL, 50 mg/1 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, Etanercept 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) |
Etanercept 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:
Etanercept pen is approved in the EU and US for the treatment of rheumatoid arthritis and other autoimmune diseases. In the EU, brands like Enbrel are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical data, biosimilarity, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We help facilitate efficient market access for etanercept pens, ensuring adherence to European and US standards for safe, effective biologic therapy and navigating complex regulatory frameworks seamlessly.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Etanercept is used to treat autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and plaque psoriasis. It works by blocking tumor necrosis factor (TNF), a substance in the body that causes inflammation and immune system overactivity.
Etanercept is a recombinant fusion protein produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It consists of the extracellular ligand-binding portion of the human TNF receptor fused to the Fc portion of human IgG1.
The main trade name of Etanercept is Enbrel.
Etanercept is manufactured by Amgen Inc. and marketed by Pfizer Inc. in certain regions.
The generic name is Etanercept.
The brand name is Enbrel.
Etanercept (Enbrel) is manufactured by Amgen Inc. in the United States and by Pfizer in Europe under licensed production facilities.
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