Pegloticase Injecatble 8 mg/1.2 mL vial 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.
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.
Pegloticase Injecatble — third party manufacturing & bulk supply
Pegloticase Injecatble 8 mg/1.2 mL vial is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Indicative minimum order quantity
Pegloticase Injecatble is supplied as Injectable (IV solution) — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.
Manufacturers of Pegloticase Injecatble listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Pegloticase Injecatble →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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