Golimumab bulk supplier for pharma manufacturers

Golimumab Suppliers & Bulk Manufacturers

Available Forms: injection (prefilled syringe)

Available Strengths: 50 mg / 0.5 mL, 100 mg / 1 mL

Reference Brands: Simponi (USA/EU)

Golimumab is a human monoclonal antibody that acts as a tumor necrosis factor-alpha (TNF-α) inhibitor. It works by binding to and neutralizing TNF-α, a pro-inflammatory cytokine involved in autoimmune and inflammatory processes. Golimumab is used in the treatment of immune-mediated disorders such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. It is available as subcutaneous injections (prefilled syringe or autoinjector) and intravenous infusion formulations.

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Product Description:

Golimumab is a fully human monoclonal antibody against tumour necrosis factor alpha. It binds both the soluble and the membrane-bound forms of TNF, preventing them from activating their receptors and so interrupting the cytokine cascade that drives joint destruction and bowel inflammation. Being fully human rather than chimeric, it provokes anti-drug antibodies less readily than infliximab.

It is used for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis. Its practical distinction is dosing frequency: the subcutaneous injection is given once a month, against every one or two weeks for adalimumab and etanercept — a meaningful difference for patients on lifelong treatment. An intravenous formulation for infusion every eight weeks exists as a separate product. The TNF class risks apply in full: serious bacterial, fungal and opportunistic infection, tuberculosis reactivation requiring screening before treatment, hepatitis B reactivation, demyelinating disease and a warning about lymphoma.

Sourcing notes. Originator biologic. A biosimilar, Gotenfia, has since been authorised in the EU, so both originator and biosimilar supply routes exist there; confirm the position in each destination market. Cold chain. Prefilled syringe, autoinjector and intravenous vial are separate registrations with different buyers.

Golimumab — third party manufacturing & bulk supply

Golimumab 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

Golimumab is supplied as injection (prefilled syringe) — 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 Golimumab 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

Golimumab is listed as injection (prefilled syringe) in 50 mg / 0.5 mL, 100 mg / 1 mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Golimumab is referenced against Simponi (USA/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.