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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)

Category: Oncology Cancer Care

Nivolumab (brand name Opdivo®) is a monoclonal antibody used in oncology to treat various cancers by blocking the PD-1 receptor, which enhances the immune system’s ability to fight cancer. It is used for melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), head and neck cancers, and more. Nivolumab is available in intravenous (IV) form in strengths of 40 mg/4 mL and 100 mg/10 mL. It is available in both the US and EU.

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📘 Sourcing Guide

Product Description:

Nivolumab (brand name Opdivo®) is a monoclonal antibody used in oncology as an immune checkpoint inhibitor. It works by targeting and blocking the PD-1 receptor on T-cells, which prevents cancer cells from evading the immune system. By doing so, Nivolumab enhances the body's immune response, allowing T-cells to identify and attack cancer cells more effectively. Nivolumab is indicated for the treatment of several cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and others. It is administered as an intravenous (IV) infusion in two available strengths: 40 mg/4 mL and 100 mg/10 mL.

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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Nivolumab listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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).

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