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 is available in Intravenous (IV) and strengths such as 40 mg/4 mL (vial); 100 mg/10 mL (vial). Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Nivolumab is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Nivolumab can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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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.

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Frequently Asked Questions

What is Nivolumab made from? 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.

What is Nivolumab trade name? The trade name of Nivolumab is Opdivo.

What company makes Nivolumab? Nivolumab (Opdivo) is developed and manufactured by Bristol Myers Squibb (BMS).

What is generic name of Nivolumab? The generic name is Nivolumab.

What is brand name of Nivolumab? The brand name is Opdivo.

Where is Nivolumab manufactured? 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).

Yes, Nivolumab is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Nivolumab is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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