Sapropterin Dihydrochloride Tablet Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 100 mg
Reference Brands: Kuvan®(US); Kuvanon®(EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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