Infliximab Intravenous (Iv) Solution 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. Infliximab Intravenous (IV) Solution is available in Intravenous (IV) Solution and strengths such as 100 mg/20 mL, 100 mg/10 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, Infliximab Intravenous (IV) Solution 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) |
Infliximab Intravenous (IV) Solution 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:
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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