Pegloticase Injecatble Suppliers & Bulk Manufacturers

Available Forms: Injectable (IV solution)

Available Strengths: 8 mg/1.2 mL vial

Reference Brands: Krystexxa (US)

Category: Arthritis

Pegloticase injecatble is available in Injectable (IV solution) and strengths such as 8 mg/1.2 mL 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, Pegloticase injecatble is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Pegloticase injecatble 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: Pegloticase injectable is approved in the US for the treatment of severe, refractory gout unresponsive to conventional therapies. In the EU, it is not widely approved; primarily marketed in the US under the brand Krystexxa (by Horizon Therapeutics). Regulatory dossiers demonstrate safety, efficacy, and manufacturing quality supported by clinical trial data. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory submissions, compliance, and registration, visit PharmaTradz. We facilitate efficient market access for pegloticase, ensuring adherence to European and US standards for safe, effective management of refractory gout, helping clients navigate complex regulatory landscapes seamlessly.