Mebeverine Tablets and capsules

Form: Tablets and capsules

Strength: 135 mg tablets and 200 mg Capsules

Reference Brands: Duspatalin(EU)

Category: Gastrointestinal Drugs

Mebeverine tablets and capsules, marketed as Duspatalin, are approved in the EU and available as generics. In the US, they are sold as OTC or prescription-only in some formulations. Regulatory approval requires dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the EU, EMA guidelines oversee safety and quality, while in the US, FDA regulations apply. For dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and worldwide availability, aiding patients with irritable bowel syndrome and intestinal spasms across regions.