Etanercept Pen 50 mg/0.5 mL, 50 mg/1 mL 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.
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.
Etanercept Pen — third party manufacturing & bulk supply
Etanercept Pen 50 mg/0.5 mL, 50 mg/1 mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Indicative minimum order quantity
Etanercept Pen is supplied as Pre-filled Syringe or Pen — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Etanercept Pen listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Etanercept Pen →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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