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Ustekinumab‑aekn bulk supplier for pharma manufacturers

Ustekinumab‑Aekn Suppliers & Bulk Manufacturers

Available Forms: Subcutaneous injection (pre-filled syringes, pens); Intravenous Infusion

Available Strengths: Intravenous Infusion(130 mg/26 mL), Subcutaneous injection (pre-filled syringes, pens)

Reference Brands: Stelara(US & EU); Selarsdi- biosimilar of Stelara

Category: Biosimilars

Selardi, a biosimilar of Stelara (ustekinumab), acts by inhibiting interleukins 12 and 23, reducing inflammation. It effectively treats psoriasis, psoriatic arthritis, and Crohn's disease. Benefits include comparable efficacy, lower cost, and supporting long-term disease management, increasing broad patient access when used under medical supervision.

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📘 Sourcing Guide

Product Description:

Selardi, a biosimilar of Stelara (ustekinumab), is regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP, EMA, and FDA standards. In the US, FDA approval involves comprehensive clinical validation and safety data. In the EU, CE marking certifies conformity with MDR standards. These biosimilars undergo validation, stability testing, and audits, supported by detailed documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality biosimilar therapies supporting affordable treatment for psoriasis, psoriatic arthritis, and Crohn’s disease worldwide.

Ustekinumab‑Aekn — third party manufacturing & bulk supply

Ustekinumab‑Aekn 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Ustekinumab‑Aekn listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'

The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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Frequently Asked Questions

Ustekinumab-aekn is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults. It helps reduce inflammation by targeting and inhibiting specific proteins in the immune system that cause inflammatory responses.

Ustekinumab-aekn is a human monoclonal antibody produced using recombinant DNA technology in a mammalian cell line. It is a biosimilar to Ustekinumab, designed to closely match the structure, efficacy, and safety of the original biologic product.

The trade name for Ustekinumab-aekn is Wezlana.

Ustekinumab-aekn (Wezlana) is manufactured by Amgen Inc.

The generic name of this product is Ustekinumab-aekn.

The brand name of Ustekinumab-aekn is Wezlana.

Ustekinumab-aekn (Wezlana) is manufactured by Amgen in the United States, with additional production and packaging facilities in Europe for global distribution.

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