Bifidobacterium species Capsule

Form: Capsules

Strength: 1-10 billion CFUs

Reference Brands: Align(US & EU)

Category: Nutraceuticals

Bifidobacterium species capsules are regulated as dietary supplements in the US and food supplements in the EU, supporting gut health and immune function. Regulatory approval requires dossiers including safety data, ingredient sourcing, manufacturing practices, and efficacy evidence. In the US, the FDA evaluates safety and labeling, while the EMA ensures regional safety and quality compliance. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability, helping consumers worldwide maintain balanced microbiomes, improve digestion, and boost immunity through high-quality probiotic formulations.