
Ustekinumab‑Aauz Suppliers & Bulk Manufacturers
Available Forms: Subcutaneous injection, Intravenous infusion
Available Strengths: 45 mg or 90 mg
Reference Brands: Stelara(US & EU); Otulfi (ustekinumab-srlf) is a biosimilar of Stelara
Category: Biosimilars
Ustekinumab‑aauz is available in Subcutaneous injection, Intravenous infusion and strengths such as 45 mg or 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‑aauz 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‑aauz 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-aauz 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 requires comprehensive clinical trial data and safety validation. In the EU, CE marking certifies conformity with MDR. These products undergo validation, stability testing, and audits, with detailed documentation including safety profiles, clinical efficacy data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective biologic therapies globally, supporting management of psoriasis, psoriatic arthritis, and Crohn’s disease for optimal patient outcomes.
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