Infliximab for IV Infusion 100 mg per vial Suppliers & Bulk Manufacturers

Available Forms: Powder for concentrate for IV infusion

Available Strengths: 100 mg per vial

Reference Brands: Remicade (US & EU)

Category: Arthritis

Infliximab 100 mg vials for intravenous infusion, an anti-TNF monoclonal antibody for rheumatology, gastroenterology and dermatology units, for hospital buyers, importers and tender authorities.

Product Description:

Infliximab is a chimeric monoclonal antibody that binds tumour necrosis factor alpha (TNF-α) and so damps down the inflammation behind several immune-mediated diseases. It is a biological medicine, and much of today's supply is biosimilar. The intravenous form is a single-use vial holding 100 mg, most often a freeze-dried powder reconstituted with 10 mL of water for injection and diluted in 250 mL of sodium chloride 0.9%.

Infliximab is used in rheumatoid arthritis with methotrexate, and in Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Induction doses are given at weeks 0, 2 and 6, then maintenance every 8 weeks. Each infusion runs over about two hours through an in-line low-protein-binding filter. Patients are screened for tuberculosis and hepatitis B first. Serious infection is the main risk, live vaccines are avoided, and it is not used in moderate to severe heart failure.

Sourcing notes. Infliximab needs a cold chain: unopened vials are kept at 2-8 °C and never frozen, so ask for validated shipping with temperature loggers and a clear excursion policy. The dossier should be a biologic or biosimilar file in CTD format, with comparability data against the reference product, immunogenicity data and a risk management plan. Each vial delivers 100 mg; confirm whether you are buying powder or ready-made concentrate. Request a CoA per batch, the GMP certificate, a CoPP and national lot release where required. State the shelf life required on arrival and pack size.