Trastuzumab bulk supplier for pharma manufacturers

Trastuzumab Suppliers & Bulk Manufacturers

Available Forms: IV & SQ Injection

Available Strengths: IV : 150 mg/ 7.5 mL (vial); SQ: 600 mg/ 5 mL (syringe)

Reference Brands: Herceptin® (EU & US); Herceptin Hylecta® (subcutaneous formulation)

Trastuzumab (Herceptin®) is a monoclonal antibody used to treat HER2-positive breast and gastric cancer. It targets the HER2 receptor, inhibiting cancer cell growth. Available in intravenous (IV) and subcutaneous (SC) formulations, it comes in 150 mg vials (IV) and 600 mg syringes (SC). Widely used in combination therapy, it improves outcomes for HER2-positive cancers in both the US and EU.

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Product Description:

Trastuzumab is a monoclonal antibody used in oncology, primarily for the treatment of HER2-positive breast cancer and gastric cancer. It works by targeting the HER2 receptor, a protein that is overexpressed in some cancer cells, blocking its signaling and inhibiting cancer cell growth. Available as Herceptin® in both the US and EU, Trastuzumab is offered in intravenous (IV) and subcutaneous (SC) formulations. The IV formulation is commonly administered in 150 mg vials, while the SC formulation is available in 600 mg syringes. Used as part of combination therapy, it improves patient outcomes in HER2-positive cancers.

Trastuzumab — third party manufacturing & bulk supply

Trastuzumab 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

Trastuzumab is supplied as IV & SQ Injection — 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 Trastuzumab 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

Trastuzumab is used in the treatment of HER2-positive breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. It works by targeting the HER2 receptor on cancer cells, inhibiting their growth and survival.

Trastuzumab is a recombinant humanized monoclonal antibody produced by recombinant DNA technology in mammalian (Chinese Hamster Ovary) cells. It specifically binds to the extracellular domain of the HER2 protein.

Trade names include Herceptin, Ogivri, Herzuma, Trazimera, Ontruzant, and Kanjinti.

Trastuzumab was originally developed and marketed by Genentech (a subsidiary of Roche). Several biosimilar versions are now produced by companies such as Mylan, Samsung Bioepis, Amgen, and Celltrion.

The generic name is trastuzumab.

Brand names include Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, and Kanjinti.

Trastuzumab and its biosimilars are manufactured in multiple WHO-GMP and US FDA-approved facilities located in the United States, Switzerland, South Korea, and India for global distribution.