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. Ustekinumab‑aekn is available in Subcutaneous injection (pre-filled syringes, pens); Intravenous Infusion and strengths such as Intravenous Infusion(130 mg/26 mL), Subcutaneous injection (pre-filled syringes, pens). Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Ustekinumab‑aekn is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Ustekinumab‑aekn can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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