Sapropterin Dihydrochloride Tablet Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 100 mg
Reference Brands: Kuvan®(US); Kuvanon®(EU)
Category:
Orphan Drugs
Sapropterin dihydrochloride enhances BH4 levels, a cofactor for phenylalanine hydroxylase, improving phenylalanine metabolism. It lowers blood phenylalanine levels, prevents neurological damage, and supports normal growth in phenylketonuria (PKU) patients. Benefits include improved metabolic control, dietary flexibility, and enhanced quality of life.
Sapropterin Dihydrochloride tablet is available in Tablets
and strengths such as 100 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, Sapropterin Dihydrochloride tablet 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) |
Sapropterin Dihydrochloride tablet 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:
Sapropterin Dihydrochloride tablets, marketed as Kuvan®, are approved for treating phenylketonuria (PKU) in the US and EU. In the US, FDA approval includes a comprehensive dossier supporting safety, efficacy, and manufacturing standards. Similarly, the European Medicines Agency (EMA) has reviewed and approved Kuvan® based on rigorous assessments. These approvals ensure high-quality, stability, and consistent dosing. For pharmaceutical companies and stakeholders, detailed regulatory dossiers are available that outline clinical data, manufacturing practices, and compliance with international standards. For more insights on regulatory processes and dossiers, visit PharmaTradz.
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