Fosdenopterin Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 9.5 mg
Reference Brands: Nulibry (USA/EU)
Category:
Critical Care
Fosdenopterin is available in Injection
and strengths such as 9.5 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, Fosdenopterin 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) |
Fosdenopterin 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:
Fosdenopterin, also known as cyclic pyranopterin monophosphate (cPMP) and marketed under the brand name Nulibry, is a first-in-class therapy for patients with molybdenum cofactor deficiency (MoCD) type A, a rare and life-threatening genetic metabolic disorder. In MoCD type A, a deficiency in the MOCS1 gene leads to insufficient production of the molybdenum cofactor, resulting in the accumulation of toxic sulfite metabolites that cause severe neurological damage early in life. Fosdenopterin acts as a synthetic replacement for cPMP, restoring the activity of critical molybdenum-dependent enzymes such as sulfite oxidase, xanthine dehydrogenase, and aldehyde oxidase. By replenishing cPMP, fosdenopterin helps normalize metabolic pathways, reduce toxic metabolite accumulation, and improve survival outcomes.
The drug is supplied as a lyophilized powder for intravenous injection, typically in 9.5 mg single-dose vials, and is administered once daily according to patient body weight. Fosdenopterin requires careful clinical supervision, and common side effects may include infusion-related reactions, fever, vomiting, diarrhea, gastroenteritis, and respiratory infections. Approved in the USA in 2021 and in the EU in 2022, fosdenopterin represents the first therapy specifically targeting MoCD type A, offering a life-saving option for affected patients.
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