Ustekinumab Injection Suppliers & Bulk Manufacturers

Available Forms: SQ and IV injection

Available Strengths: SQ:: 45 mg, 90 mg; IV: 130 mg/vial

Reference Brands: Stelara(US)

Category: Immune Disorder

Ustekinumab Injection is available in SQ and IV injection and strengths such as SQ:: 45 mg, 90 mg; IV: 130 mg/vial. 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 Injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Ustekinumab Injection 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 injection, marketed as Stelara, is approved in the US by the FDA and in the EU via EMA for Crohn’s disease, psoriatic arthritis, and psoriasis. Regulatory approval requires comprehensive dossiers including clinical trial data, manufacturing details, safety, efficacy, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality data, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Ensuring thorough regional compliance is essential for the safe, effective, and timely approval of ustekinumab injectable products worldwide, supporting optimal patient outcomes in autoimmune disease management.