Sotalol Tablet Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 80 mg, 120 mg, 160 mg, 240 mg

Reference Brands: Betapace:(US & EU)

Category: Heart Disorder

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 tablet is available in Tablet and strengths such as 80 mg, 120 mg, 160 mg, 240 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Sotalol tablet is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Sotalol tablet can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description:

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.