Azithromycin shortage — AU supply status & alternatives

Azithromycin

ATC J01FA10 · Macrolide antibiotic

🇦🇺 AUST R 334520 · AFT Pharmaceuticals Pty Ltd

In shortage · Australia

WHO Essential Medicine

Z-PakAzasite ZithromaxAzitromicina EgAzitromicina Alter+2 more

In declared shortage · 🇦🇺 Australia & also short in🇺🇸 US🇨🇦 CA🇮🇪 IE🌐 MY

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$3.98DPMQ A$35.52details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Claritromicina

◷ Expected back

Feb 2027

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Azithromycin
Brand names	Z-Pak, Azasite, Zithromax, Azitromicina Eg, Azitromicina Alter, Azitromicina Sandoz +1 more
ATC level 5	J01FA10
ATC level 4	J01FA
Drug class	Macrolide antibiotic
Therapeutic category	Anti-infective
Strength	250mg · 500mg · 1g
Dosage form	tablet · capsule · oral suspension · powder for infusion
Route of administration	oral · intravenous
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	AFT Pharmaceuticals Pty Ltd, Medicianz Healthcare Pty Ltd, ACCORD-UK LIMITED, TEVA UK LIMITED +5 more
Registrations on file	18
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$3.98

AEMP

Dispensed (DPMQ)

A$35.52

incl. fees

Pack

azithromycin 500 mg tablet, 3

tablet

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.81

Drug Tariff

🇺🇸 US

US$0.39

Acquisition

🇪🇸 ES

€5.62

Retail price

🇮🇹 IT

€6.32

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

Kopran Research Laboratories LTDCentury Pharmaceuticals LTDTapi Nl BVWockhardt LTDAlembic Pharmaceuticals LTDJubilant Biosys LTD+11 more

Manufacturing countries: India, United States, China, Israel · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

May 2022

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA · just now

Critical

🇦🇺

Australia

TGA · just now

Critical

🇨🇦

Canada

HC · just now

High

🌐

NPRA · 5h ago

Medium

🇮🇪

Ireland

HPRA · 1mo ago

Medium

Recalls official enforcement reports

🇺🇸

AZITHROMYCIN

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

🇺🇸

Azithromycin

Kroger Specialty Pharmacy, Inc. · Apr 2018

Class IIdetails ↗

🇺🇸

Azithromycin

PD-Rx Pharmaceuticals, Inc. · Apr 2015

Class IIdetails ↗

🇺🇸

Azithromycin

Health Innovations Pharmacy, Inc · Feb 2015

Class IIdetails ↗

Verified timeline regulator events

🇦🇺 1 Aug 2026

high reported

🇦🇺 1 Aug 2026

high reported

🇨🇦 28 Apr 2026

medium reported

🇺🇸 9 Apr 2026

medium reported

🇮🇪 26 Jan 2026

medium reported

🇺🇸 20 Jan 2026

medium reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA

verified just now

verify ↗

🇦🇺

TGA

verified just now

verify ↗

🌐

NPRA

verified 5h ago

verify ↗

🇮🇪

HPRA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
Aft	500 mg	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
Tih	500 mg	—	🇦🇺 AU	—	Active
Viatris	500 mg	—	🇦🇺 AU	—	Active
Medsurge	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Medicianz	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
AZITHROMYCIN 250MG FILM COATED TABLETS	250MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AZITHROMYCIN 500MG FILM-COATED TABLETS	500MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AZITHROMYCIN 250MG FILM-COATED TABLETS	250MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
AZITHROMYCIN 500 MG FILM-COATED TABLETS	500 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
AZITHROMYCIN 200MG/5ML POWDER FOR SUSPENSION	200MG	suspension	🇬🇧 GB	TEVA UK LIMITED	Active
AZITHROMYCIN 250MG CAPSULES	250MG	capsule	🇬🇧 GB	TEVA UK LIMITED	Active
AZITHROMYCIN 250MG TABLETS	250MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
AZITHROMYCIN 500MG TABLETS	500MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
AZITHROMYCIN 200 MG/5 ML POWDER FOR ORAL SUSPENSION	200 MG	suspension	🇬🇧 GB	SANDOZ LIMITED	Active
AZITHROMYCIN 500MG FILM COATED TABLETS	500MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active

+3 more registrations on file

Mederti Drug Report

Generated 2 July 2026 · Australia market · 5 regulatory sources

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.