Sapropterin Dihydrochloride Tablet 100 mg 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.
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.
Sapropterin Dihydrochloride Tablet — third party manufacturing & bulk supply
Sapropterin Dihydrochloride Tablet 100 mg 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
Sapropterin Dihydrochloride Tablet is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 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 Sapropterin Dihydrochloride Tablet 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 Sapropterin Dihydrochloride Tablet →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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