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.
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