L-Ornithine L-Aspartate powder

Form: Powder for Reconstitution for oral use

Strength: 5 g, 10 g, or 15 g

Reference Brands: Liv.52, HepaMerz(EU)

Category: Gastrointestinal Drugs

L-Ornithine L-Aspartate powder is used extensively in Europe for managing hepatic encephalopathy and supporting liver function. In the EU, it is regulated as a medicinal product with dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans submitted to EMA. In the US, it is mainly available as compounded or compounded formulations, with limited commercial products approved. Dossiers should include comprehensive clinical and safety data, manufacturing details, and quality controls. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence facilitates timely approval, safe use, and wider availability, supporting liver health management worldwide.