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