Barium Sulfate Suspension

Form: Powder for oral suspension

Strength: 30% w/v , 40% w/v

Reference Brands: Gastroview, Osmo-Maq, FlexiView(US)

Category: Contrast Agent

Barium sulfate suspensions, marketed as Gastroview and Osmo-Maq in the US and EU, are approved for gastrointestinal imaging procedures. Regulatory approval requires detailed dossiers, including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with safety and manufacturing standards across Europe. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and global availability, enabling accurate GI tract imaging for diagnosis and treatment planning worldwide, thus improving patient care across healthcare regions.