Obinutuzumab bulk supplier for pharma manufacturers

Obinutuzumab 25 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 25 mg/mL

Reference Brands: Gazyva (USA), Gazyvaro (EU/UK)

Obinutuzumab is a humanized, glycoengineered monoclonal antibody targeting the CD20 antigen on B-cells. It is used alongside chemotherapy for conditions such as chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL) to enhance B-cell destruction via immune mediated mechanisms.

Ask About Access

Usually answered within 48 hours | GMP documents shared before you commit

Manufacture or export Obinutuzumab? List it or send an offer →

Product Description:

Obinutuzumab is a glycoengineered type II antibody against CD20. Two modifications separate it from rituximab. The sugar structure on its Fc region has been altered to remove fucose, which greatly increases its affinity for the receptor on natural killer cells and therefore the strength of antibody-dependent cell killing. And as a type II antibody it binds CD20 differently, causing direct cell death rather than relying mainly on complement.

It is used for chronic lymphocytic leukaemia with chlorambucil or venetoclax, and for follicular lymphoma with chemotherapy and as maintenance. It is also used as a pretreatment before some bispecific antibodies to reduce cytokine release. Infusion-related reactions during the first dose are common and can be severe, so the initial infusion is split across two days and given slowly with premedication. Tumour lysis syndrome, prolonged neutropenia, hepatitis B reactivation — screening is mandatory — and progressive multifocal leukoencephalopathy are recognised risks.

Sourcing notes. Originator biologic under patent, with different brand names in the United States and Europe for the same product. Cold chain at 2–8 degrees, protect from light, no freezing or shaking. Hepatitis B screening capability at the destination is a practical prerequisite.

How Obinutuzumab is supplied today, and licensing ahead of patent expiry

Obinutuzumab is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Obinutuzumab, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

Ask about Obinutuzumab supply →

Back to Listing

Frequently Asked Questions

Obinutuzumab is used to treat certain types of blood cancers, including chronic lymphocytic leukemia (CLL) and follicular lymphoma. It works by targeting the CD20 protein found on the surface of B-lymphocytes, helping the immune system destroy these cancerous cells.

Obinutuzumab is a humanized monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It specifically binds to the CD20 antigen on B-cells, leading to their destruction.

The trade name of Obinutuzumab is Gazyva in the United States and Gazyvaro in the European Union and the United Kingdom.

Obinutuzumab (Gazyva/Gazyvaro) is developed and manufactured by Genentech, a member of the Roche Group.

The generic name is Obinutuzumab.

The brand names are Gazyva and Gazyvaro.

Obinutuzumab is manufactured by Roche and Genentech at facilities in Switzerland, Germany, and the United States under stringent biologic production standards.

Obinutuzumab is sold as Gazyva and Gazyvaro. It is developed and sold by Roche (Genentech). PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.