Dronedarone hydrochloride bulk supplier for pharma manufacturers

Dronedarone Hydrochloride 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. Dronedarone hydrochloride is available in Tablets and strengths such as 400 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, Dronedarone hydrochloride is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Dronedarone hydrochloride 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.

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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.

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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.

Yes, Dronedarone hydrochloride is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Dronedarone hydrochloride is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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