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Ustekinumab (AUUB) bulk supplier for pharma manufacturers

Ustekinumab (Auub) 45 mg & 90 mg Suppliers & Bulk Manufacturers

Available Forms: Injectable solution (subcutaneous administration)

Available Strengths: 45 mg & 90 mg

Reference Brands: Stelara(US & EU); Wezlana (ustekinumab-auub) is a biosimilar of Stelara

Category: Biosimilars

Welzana, a biosimilar of Stelara (ustekinumab), works by blocking interleukins 12 and 23, reducing inflammation. It effectively treats psoriasis, psoriatic arthritis, and Crohn's disease. Benefits include similar efficacy to the original, lower cost, and supporting long-term disease management when administered under medical supervision.

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Product Description:

Ustekinumab (AUUB) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality compliant with GMP and MDR standards. In the US, FDA approval involves rigorous clinical validation, safety assessments, and GMP compliance. In the EU, CE marking certifies conformity with MDR regulations. The product undergoes validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective biologic therapies for psoriasis, psoriatic arthritis, and Crohn's disease worldwide, supporting healthcare and patient management effectively.

Ustekinumab (Auub) — third party manufacturing & bulk supply

Ustekinumab (Auub) 45 mg & 90 mg 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

Ustekinumab (Auub) is supplied as Injectable solution (subcutaneous administration) — 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 Ustekinumab (Auub) 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

Ustekinumab (AUUB) is listed as Injectable solution (subcutaneous administration) in 45 mg & 90 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Ustekinumab (AUUB) is referenced against Stelara(US & EU); Wezlana (ustekinumab-auub) is a biosimilar of Stelara. Reference brands are shown for identification only and remain the property of their respective trademark owners.

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