Saccharomyces boulardii: capsules

Form: Capsules

Strength: 250 mg

Reference Brands: Florastor(US)

Category: Nutraceuticals

Saccharomyces boulardii capsules, marketed as Florastor, are approved in the US by the FDA and in the EU via EMA as dietary supplements for supporting gastrointestinal health. Regulatory approval requires dossiers including safety data, ingredient sourcing, manufacturing standards, and efficacy evidence. The FDA reviews safety and quality, while the EMA ensures compliance with regional safety and manufacturing regulations. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and global availability, helping millions worldwide maintain gut balance, prevent diarrhea, and support immune health through high-quality probiotic supplementation.