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.
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.
Sotalol Tablet — third party manufacturing & bulk supply
Sotalol Tablet is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Sotalol Tablet listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Sotalol Tablet →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Sotalol hydrochloride is used to treat and manage certain types of heart rhythm disorders, including ventricular arrhythmias and atrial fibrillation or atrial flutter. It helps maintain a normal, steady heartbeat and reduces the risk of serious rhythm-related complications by regulating the electrical activity of the heart.
Sotalol is made from the active pharmaceutical ingredient sotalol hydrochloride, which has both beta-adrenergic blocking properties and antiarrhythmic activity that works on cardiac ion channels.
Common trade names include Betapace, Betapace AF, and Sotylize (oral solution brand in some markets).
The original branded versions were marketed by companies such as Bayer and Berlex in the past, and today sotalol hydrochloride products are manufactured by multiple global generic pharmaceutical companies.
The complete generic name is sotalol hydrochloride.
Major brand names include Betapace and Betapace AF.
Sotalol hydrochloride products are manufactured in the USA, EU, UK, India, and other countries by GMP-certified pharmaceutical manufacturers for regulated cardiovascular markets.
Related Products
Trandolapril
Strength:
0.5 mg, 1 mg, 2 mg
Form: Tablets
Reference Brands: Mavik (USA), Gopten (EU)
View Details
Tirofiban Hydrochloride
Strength:
2.5 mg/mL
Form: Injection
Reference Brands: Aggrastat (USA)
View Details
Selexipag
Strength:
200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg
Form: Tablets / Injection
Reference Brands: Uptravi (USA/EU)
View Details
Edoxaban
Strength:
15 mg, 30 mg, 60 mg
Form: Tablets
Reference Brands: Savaysa (USA), Lixiana (EU)
View DetailsQuick Response Guaranteed | Verified Suppliers
