Dronedarone shortage — IT supply status & alternatives

Dronedarone

ATC C01BD07

In supply · Australia

Dronedarone Aurobindo

In supply · 🇦🇺 Australia · short in🇮🇹 IT

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Dronedarone
Brand names	Dronedarone Aurobindo
ATC level 5	C01BD07
ATC level 4	C01BD
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	ASCEND LABORATORIES LTD

Registrations on file	1

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇺🇸 US

US$13.19

Acquisition

🇮🇹 IT

€46.54

Retail price

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

17 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Low concentration risk

Wisdom Pharmaceutical CO LTDSanofi Winthrop IndustrieUnimark Remedies LTDAlivus Life Sciences LTDChemwerth INCAlkem Laboratories LTD+11 more

Manufacturing countries: China, France, India · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇮🇹

Italy

AIFA · 3d ago

Medium

Recalls official enforcement reports

🇺🇸

Dronedarone Hcl

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Verified timeline regulator events

🇮🇹 2 July 2026

medium reported

🇮🇹 10 Sept 2025

medium reported

Sources official regulators

🇮🇹

AIFA

verified 3d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders1 registration · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
Asn-Dronedarone	—	tablet	🇨🇦 CA	ASCEND LABORATORIES LTD	Active

Mederti Drug Report

Generated 7 July 2026 · Australia market · 1 regulatory source

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.