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Dronedarone hydrochloride bulk supplier for pharma manufacturers

Dronedarone Hydrochloride 400 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 400 mg

Reference Brands: Multaq (USA/EU)

Category: Heart Disorder

Dronedarone hydrochloride is a class III antiarrhythmic medication used to maintain normal heart rhythm in adults with a history of atrial fibrillation or atrial flutter. It helps reduce the risk of hospitalization due to these rhythm disorders. The drug is given orally as a 400 mg tablet taken twice daily with food. It works by blocking multiple cardiac ion channels to stabilize electrical activity in the heart. Dronedarone is an alternative to amiodarone with a modified chemical structure aimed at reducing certain toxicities.

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📘 Sourcing Guide

Product Description:

Dronedarone hydrochloride is a small‑molecule antiarrhythmic medication indicated primarily for adults with a history of paroxysmal or persistent atrial fibrillation or atrial flutter who are in normal sinus rhythm and at risk of recurrence. It is used to help maintain normal heart rhythm and reduce the risk of hospitalization due to arrhythmia. Dronedarone belongs to the class III antiarrhythmic group and exhibits multichannel blocking effects on potassium, sodium, and calcium channels, and has additional antiadrenergic properties. Compared with its related drug amiodarone, dronedarone lacks iodine moieties, which is intended to reduce the risk of thyroid and pulmonary toxicities associated with amiodarone. The medication is supplied in 400 mg film‑coated tablets, typically taken twice daily with meals to improve absorption. While it can be effective in rhythm control, dronedarone must be used cautiously due to potential side effects, including liver injury and interactions with other medications. It is contraindicated in certain patients, such as those with severe heart failure or permanent atrial fibrillation. In the United States, it is marketed under the brand Multaq, and similar branded and generic forms are available in the European Union and United Kingdom.

Dronedarone Hydrochloride — third party manufacturing & bulk supply

Dronedarone Hydrochloride 400 mg 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.

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 Dronedarone Hydrochloride 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.

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Frequently Asked Questions

Dronedarone hydrochloride is used to help maintain normal heart rhythm and reduce the risk of hospitalization in adults with a history of atrial fibrillation or atrial flutter who are currently in normal sinus rhythm.

Dronedarone is a synthetic antiarrhythmic compound formulated as dronedarone hydrochloride that works by blocking multiple cardiac ion channels to stabilize electrical activity in the heart.

The primary trade name for dronedarone is

Dronedarone (Multaq) is manufactured and marketed by pharmaceutical companies licensed for its distribution; originally developed by Sanofi and now also produced as generic formulations by various manufacturers.

The generic name of Multaq is

The brand name of dronedarone is

Dronedarone hydrochloride tablets are manufactured in regulated pharmaceutical facilities by companies authorized to produce and distribute the drug in different regions.

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