Nivolumab bulk supplier for pharma manufacturers

Nivolumab Suppliers & Bulk Manufacturers

Available Forms: Intravenous (IV)

Available Strengths: 40 mg/4 mL (vial); 100 mg/10 mL (vial)

Reference Brands: Opdivo® (EU & US)

Nivolumab 10 mg/mL concentrate for infusion in 40 mg/4 mL and 100 mg/10 mL vials, an anti-PD-1 antibody used in several advanced cancers. For hospital oncology pharmacies, cancer centres, tender buyers and licensed importers.

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Product Description:

Nivolumab is a fully human IgG4 antibody against the programmed death-1 (PD-1) receptor. By occupying the receptor, it stops tumour cells using the PD-1 pathway as a brake on cytotoxic T cells, so an existing anti-tumour response can resume. The vials on this page hold a 10 mg/mL concentrate: 40 mg in 4 mL and 100 mg in 10 mL. Two vial sizes let pharmacies make up doses with less waste. It is infused undiluted or diluted in sodium chloride 0.9% or glucose 5%.

It is used in advanced and resected melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial, oesophageal and gastric cancers, among others, sometimes with ipilimumab or chemotherapy. Flat doses of 240 mg every two weeks or 480 mg every four weeks, over 30 minutes through an in-line filter, are common. Immune-related pneumonitis, colitis, hepatitis, nephritis and endocrine disorders can appear even after the last dose. Patients carry an alert card and have regular blood tests.

Sourcing notes. Nivolumab is a prescription-only biological for hospital oncology units. Vials are kept at 2-8 °C, protected from light and never frozen, so quotes should include validated insulated shippers with continuous temperature recording. When enquiring, give the split between 40 mg and 100 mg vials, total quantity and destination. A non-reference product needs its own biosimilar approval, so check registration and patent position. Request the batch certificate of analysis, GMP certificate for the biologics site, a CoPP and any lot release certificate. Dossiers follow CTD format.

Nivolumab — third party manufacturing & bulk supply

Nivolumab 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.

Indicative minimum order quantity

Nivolumab is supplied as Intravenous (IV) — 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 Nivolumab listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Nivolumab is used in the treatment of various types of cancer, including melanoma, non–small cell lung cancer (NSCLC), renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and colorectal cancer. It works as an immune checkpoint inhibitor by blocking the PD-1 receptor, thereby enhancing the immune system’s ability to detect and destroy cancer cells.

Nivolumab is a fully human IgG4 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It specifically binds to the programmed death-1 (PD-1) receptor on T cells to inhibit its interaction with PD-L1 and PD-L2.

The trade name of Nivolumab is Opdivo.

Nivolumab (Opdivo) is developed and manufactured by Bristol Myers Squibb (BMS).

The generic name is Nivolumab.

The brand name is Opdivo.

Nivolumab is manufactured by Bristol Myers Squibb at its biopharmaceutical production facilities in the United States and Europe, including facilities in Devens (Massachusetts, USA) and Cruiserath (Ireland).