Pembrolizumab Inj 25 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 25 mg/mL

Reference Brands: Keytruda (USA/EU)

Category: Oncology Cancer Care

Pembrolizumab 25 mg/mL concentrate for infusion (100 mg/4 mL vial), an anti-PD-1 monoclonal antibody used in cancer immunotherapy. For hospital oncology pharmacies, tender buyers and licensed importers of cold chain biologicals.

Product Description:

Pembrolizumab is a humanised IgG4 monoclonal antibody that binds the PD-1 receptor on T cells. Many tumours switch off the immune response by engaging PD-1 through its ligands PD-L1 and PD-L2; blocking that contact frees T cells to act against the tumour. It is supplied as a 25 mg/mL concentrate for infusion, the usual vial holding 100 mg in 4 mL. Made by recombinant cell culture, the protein must be diluted before use and handled gently, since shaking can damage it.

Oncologists use pembrolizumab in a growing list of cancers, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma and tumours with high microsatellite instability, alone or with chemotherapy. Some indications need a validated PD-L1 test first. Adults commonly receive 200 mg every three weeks or 400 mg every six weeks over 30 minutes through an in-line filter. Immune-mediated inflammation of the lungs, bowel, liver, kidneys, skin, thyroid or pituitary is the main safety concern.

Sourcing notes. Store vials at 2-8 °C in the carton to protect from light, without freezing or shaking; shipments need validated cold chain packaging and temperature loggers. It is a prescription-only biological for specialist use. Confirm whether the product is the reference medicine or a biosimilar, and that it is registered in your market, since biosimilar CTD dossiers carry comparability data your regulator will review. Ask for the batch certificate of analysis, GMP certificate, CoPP and official batch release where required. Check patent status before ordering.