Ustekinumab Injection Suppliers & Bulk Manufacturers

Available Forms: SQ and IV injection

Available Strengths: SQ:: 45 mg, 90 mg; IV: 130 mg/vial

Reference Brands: Stelara(US)

Category: Immune Disorder

Ustekinumab injection as 45 mg and 90 mg subcutaneous syringes and a 130 mg intravenous vial. An anti-IL-12/23 biologic listed for hospitals, specialist distributors and licensed importers with cold-chain capability.

Product Description:

Ustekinumab is a fully human IgG1 monoclonal antibody. It binds the p40 subunit that interleukin-12 and interleukin-23 share, so neither cytokine can signal through its receptor. This page covers both presentations. The subcutaneous 45 mg and 90 mg prefilled syringes are used for maintenance, often given by the patient or a nurse at home. The intravenous 130 mg vial, at 5 mg/mL, is used once as a weight-based induction infusion in inflammatory bowel disease.

Ustekinumab is approved for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. In psoriasis, dosing is subcutaneous throughout: 45 mg, or 90 mg in heavier patients, at weeks 0 and 4, then every 12 weeks. In Crohn's disease and ulcerative colitis, one IV infusion, diluted in sodium chloride 0.9% and run over at least an hour, is followed by subcutaneous 90 mg maintenance. Tuberculosis screening comes first. Serious infection is the main precaution, and live vaccines are avoided during treatment.

Sourcing notes. This is a biologic and a true cold-chain product. Syringes and vials are stored at 2-8 °C, never frozen, in the carton to protect them from light. Ask for temperature-logged shipping in validated packaging and a written excursion policy. Registration follows the biologics pathway with a full CTD quality file, so check whether your market expects the reference product or accepts a biosimilar. Request the batch CoA, GMP certificate, CoPP and, where national rules require it, lot release evidence. State presentation, quantity, remaining shelf life on arrival and your biologics import licence.