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Infliximab Intravenous (IV) Solution bulk supplier for pharma manufacturers

Infliximab Intravenous (Iv) Solution 100 mg/20 mL, 100 mg/10 mL Suppliers & Bulk Manufacturers

Available Forms: Intravenous (IV) Solution

Available Strengths: 100 mg/20 mL, 100 mg/10 mL

Reference Brands: Remicade (US & EU)

Category: Arthritis

Infliximab is a monoclonal antibody that binds to TNF-alpha, blocking its role in inflammation. It reduces joint swelling, pain, and tissue damage in rheumatoid arthritis. Benefits include rapid symptom relief, slowed disease progression, improved joint function, and effective management of severe autoimmune conditions when administered intravenously.

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Product Description:

Infliximab IV solution is approved in the EU and US for treating rheumatoid arthritis and other autoimmune diseases. In the EU, brands like Remicade 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 support efficient market access for infliximab IV formulations, ensuring adherence to European and American standards for safe, effective biologic therapy, helping you navigate complex regulatory frameworks seamlessly.

Infliximab Intravenous (Iv) Solution — third party manufacturing & bulk supply

Infliximab Intravenous (Iv) Solution 100 mg/20 mL, 100 mg/10 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

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

Infliximab Intravenous (Iv) Solution is supplied as Intravenous (IV) Solution — 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 Infliximab Intravenous (Iv) Solution 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.

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Frequently Asked Questions

Infliximab is used to treat autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It helps reduce inflammation and suppresses abnormal immune activity in these chronic inflammatory conditions.

Infliximab is a chimeric monoclonal antibody produced using recombinant DNA technology in mammalian (Chinese hamster ovary) cells. It is composed of human constant regions and murine variable regions that specifically bind to tumor necrosis factor-alpha (TNF-α).

The main trade name of Infliximab is Remicade.

Infliximab (Remicade) is manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. It is also marketed by Merck & Co. and other licensed partners in different regions.

The generic name is Infliximab.

The brand name is Remicade, and biosimilars include Inflectra, Renflexis, and Avsola.

Infliximab is manufactured by Janssen Biotech in the United States and by Merck & Co. in Europe and Asia at licensed biotechnology facilities.

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