Methadone shortage — MY supply status & alternatives

Methadone

—

🇦🇺 AUST R 377467 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

WHO Essential Medicine

In supply · 🇦🇺 Australia · short in🌐 MY

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.06DPMQ A$23.39details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)

Therapeutic category	Auto-created by National Pharmaceutical Regulatory Agency — Safety Alerts scraper

WHO Essential Medicine	Yes · 24.5.3. Medicines for opioid use disorders (2023)

Controlled substance	No

Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, AFT Pharmaceuticals Pty Ltd, ACCORD-UK LIMITED, THORNTON & ROSS LIMITED +9 more

Registrations on file	26

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$3.06

AEMP

Dispensed (DPMQ)

A$23.39

incl. fees

Pack

methadone hydrochloride 5 mg tablet, 20

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.17

Acquisition

🇬🇧 GB

£4.30

Drug Tariff

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

1 API manufacturer

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.

Very high concentration risk

Specgx LLC

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🌐

NPRA · 9d ago

Medium

Recalls official enforcement reports

🇺🇸

Methadone

Liberty Drug & Surgical · June 2015

Class IIdetails ↗

Verified timeline regulator events

🌐 1 Jan 2022

medium reported

Sources official regulators

🌐

NPRA

verified 9d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders26 registrations · 13 MA holders

Product	Strength	Form	Market	MA holder	Status
ASPEN METHADONE INJECTION methadone hydrochloride	10mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
OPOD-D METHADONE SYRUP methadone hydrochloride	25mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ASPEN METHADONE LIQUID methadone hydrochloride	5 mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
AFT methadone hydrochloride	5 mg	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
AFT methadone hydrochloride	10 mg	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
METHADONE 1 MG/ML ORAL SOLUTION SUGAR FREE	1 MG	solution	🇬🇧 GB	ACCORD-UK LIMITED	Active
Methadone Mixture	1MG	methadone	🇬🇧 GB	THORNTON & ROSS LIMITED	Active
METHADONE 1MG/ML ORAL SOLUTION BP-SUGAR FREE	1MG	solution	🇬🇧 GB	THORNTON & ROSS LIMITED	Active
Methadone Hydrochloride Dtf	1MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Methadone Hydrochloride Sugar Free	1MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
METHADONE 10MG/ML INJECTION	10MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
METHADONE 5 MG TABLETS	5 MG	tablet	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
METHADONE 50MG/ML INJECTION	50MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
METHADONE 1MG/ML ORAL SOLUTION	1MG	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Methadone Alkaloid	1 MG	solution	🇬🇧 GB	ALKALOID-INT DOO	Active

+11 more registrations on file

Mederti Drug Report

Generated 1 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.