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

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.

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.