Ustekinumab (Auub) 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.
Ustekinumab (AUUB) is available in Injectable solution (subcutaneous administration)
and strengths such as 45 mg & 90 mg.
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 (AUUB) 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 (AUUB) 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:
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.
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