Product/Composition:- | Sapropterin Dihydrochloride tablet |
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Strength:- | 100 mg |
Form:- | Tablets |
Reference Brands:- | Kuvan®(US); Kuvanon®(EU) |
MOQ | As per the manufacturer batch size |
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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 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.