Sotalol tablet bulk supplier for pharma manufacturers

Sotalol Tablet Suppliers & Bulk Manufacturers

Available Forms: Tablet

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

Reference Brands: Betapace:(US & EU)

Sotalol hydrochloride tablets 80 mg to 240 mg, a beta-blocker with class III antiarrhythmic action for ventricular arrhythmias and atrial fibrillation, for importers, hospital pharmacies and distributors.

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Product Description:

Sotalol is a non-selective beta-blocker that also blocks cardiac potassium channels. This class III action makes it an antiarrhythmic rather than a routine blood pressure medicine. It is excreted almost entirely unchanged by the kidneys, so dosing depends on renal function. This page covers sotalol hydrochloride tablets in 80 mg, 120 mg, 160 mg and 240 mg, usually scored for dose steps.

Sotalol is used for documented life-threatening ventricular arrhythmias and to maintain sinus rhythm in symptomatic atrial fibrillation or flutter. Its benefit comes with a real risk: it prolongs the QT interval and can cause torsades de pointes. Treatment is therefore often started or increased in hospital with ECG monitoring, and the dosing interval is set by creatinine clearance. Potassium and magnesium should be normal first. It is contraindicated in asthma, sinus bradycardia, long QT syndrome and severe renal impairment, and is not combined with other QT-prolonging drugs. It should not be stopped abruptly.

Sourcing notes. Sotalol tablets are a prescription-only generic with pharmacopoeial monographs for substance and tablet. Ask for a CTD or ACTD dossier with bioequivalence data against the reference product, and zone IVb stability where your market needs it. Tablets come in PVC/PVdC or aluminium blisters or HDPE bottles, stored at room temperature away from moisture. The CoA per batch should cover assay, dissolution, related substances and uniformity of dosage units. Request the GMP certificate and a CoPP. Not every strength is registered in every market, so list the strengths you need.

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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Sotalol Tablet is supplied as Tablet — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

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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.