Sapropterin Dihydrochloride tablet
Form: Tablets
Strength: 100 mg
Reference Brands: Kuvan®(US); Kuvanon®(EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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