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 is a recombinant enzyme that converts uric acid into allantoin, which is easily excreted by the kidneys. It rapidly reduces serum uric acid levels, effectively treating severe refractory gout. Benefits include quick gout attack relief, prevention of urate crystal formation, and improved quality of life in patients unresponsive to other therapies.
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.
|
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) |
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.
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