Sotalol Tablet Generics - Manufacturers & Suppliers
Betapace:(US & EU)
| Product/Composition:- | Sotalol tablet |
|---|---|
| Strength:- | 80 mg, 120 mg, 160 mg, 240 mg |
| Form:- | Tablet |
| Reference Brands:- | Betapace:(US & EU) |
| MOQ | As per the manufacturer batch size |
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Sotalol is a beta-blocker that also blocks potassium channels, helping to slow heart rate and stabilize electrical activity. It reduces arrhythmia episodes, prevents abnormal heart rhythms, and improves cardiac function. Benefits include effective rhythm control, decreased symptoms, and enhanced quality of life in patients with atrial and ventricular arrhythmias.
Sotalol tablets, marketed as Betapace, are approved in the US by the FDA and in the EU via EMA for treating atrial and ventricular arrhythmias. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial results and manufacturing quality, while, in the EU, the EMA ensures compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance facilitates timely approval, safe use, and global availability of sotalol tablets, supporting effective arrhythmia management worldwide.