Amiodarone shortage — IT supply status & alternatives

Amiodarone

ATC C01BD01

🇦🇺 AUST R 233673 · Juno Pharmaceuticals Pty Ltd

In supply · Australia

Cordarone

In supply · 🇦🇺 Australia · short in🇺🇸 US🇮🇹 IT🌐 MY

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$4.00DPMQ A$18.60details →

✓ 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

Brand names	Cordarone

ATC level 5	C01BD01

ATC level 4	C01BD

Therapeutic category	Auto-created by Agence nationale de sécurité du médicament — Disponibilité scraper

Controlled substance	No

Marketing-authorisation holders	ACCORD-UK LIMITED, HAMELN PHARMA LTD, Juno Pharmaceuticals Pty Ltd, AURUM PHARMACEUTICALS LIMITED +8 more

Registrations on file	19

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$4.00

AEMP

Dispensed (DPMQ)

A$18.60

incl. fees

Pack

amiodarone hydrochloride 200 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£4.37

Drug Tariff

🇺🇸 US

US$0.39

Acquisition

🇮🇹 IT

€4.52

Retail price

🇫🇷 FR

€8.18

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

9 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

Cambrex Profarmaco Milano SrlPmc IsochemTaro Pharmaceutical Industries LTDAlivus Life Sciences LTDPiramal Pharma LTDCtx Life Sciences PVT LTD+3 more

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

Shortage status by regulator official notices

🇺🇸

United States

ANSM Ruptures · 3mo ago

High

🇮🇹

Italy

AIFA · 2h ago

Medium

🌐

NPRA · 2d ago

Medium

🇫🇷

France

ANSM · 2mo ago

Resolved

Recalls official enforcement reports

🇺🇸

AMIODARONE HYDROCHLORIDE

Mylan Institutional LLC · Aug 2020

Class Idetails ↗

🇺🇸

AMIODARONE HYDROCHLORIDE

AuroMedics Pharma LLC · Nov 2019

Class IIIdetails ↗

🇺🇸

AMIODARONE HYDROCHLORIDE

AuroMedics Pharma LLC · Nov 2019

Class IIIdetails ↗

🇺🇸

AMIODARONE HYDROCHLORIDE

AuroMedics Pharma LLC · Nov 2019

Class IIIdetails ↗

🇺🇸

NEXTERONE

Baxter Healthcare Corporation · Nov 2017

Class Idetails ↗

🇺🇸

Amiodarone

SSM Health Care St. Louis DBA SSM St. Clare Health Center · Aug 2017

Class IIdetails ↗

Verified timeline regulator events

🇮🇹 26 June 2026

medium reported

🇮🇹 31 May 2026

medium reported

🇮🇹 10 Dec 2025

medium reported

🇮🇹 9 Dec 2025

medium reported

🇮🇹 30 Nov 2025

Shortage resolved

🇮🇹 26 Nov 2025

medium reported

Sources official regulators

🇮🇹

AIFA

verified 2h ago

verify ↗

🌐

NPRA

verified 2d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 3mo ago

verify ↗

🇫🇷

ANSM

verified 2mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
AMIODARONE 30 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE	30 MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active
Amiodarone Hydrochloride	20 MG	solution	🇬🇧 GB	HAMELN PHARMA LTD	Active
Amiodarone Hydrochloride	50 MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
JUNO amiodarone hydrochloride	150mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
AMIODARONE 30MG/ML INJECTION	30MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Amiodarone Hydrochloride	100MG	tablet	🇬🇧 GB	Aurobindo Pharma Limited	Active
Amiodarone Hydrochloride	200MG	tablet	🇬🇧 GB	Aurobindo Pharma Limited	Active
Amiodarone Hydrochloride	200 MG	tablet	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
AMIODARONE 100MG TABLETS	100MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
AMIODARONE 200MG TABLETS	200MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
AMIODARONE 100MG TABLETS BP	100MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
AMIODARONE 200MG TABLETS BP	200MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
AMIODARONE 100 MG TABLETS	100 MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
AMIODARONE 200 MG TABLETS	200 MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
AMIODARONE 150 MG/3 ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION	150 MG	injection	🇬🇧 GB	IBIGEN SRL	Active

+4 more registrations on file

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.