Gliclazide shortage — AU supply status & alternatives

Gliclazide

ATC A10BB09

🇦🇺 AUST R 337483

In shortage · Australia

Apx

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇮🇹 IT🇧🇪 BE🇳🇱 NL

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$3.92DPMQ A$22.68details →

✓ Can I substitute?

Yes — under S19A

TGA s19A · gliclazide-80-mg-tablets-crescent-pharma-uk

⇄ Best alternative

Metformin

◷ Expected back

Aug 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Gliclazide
Brand names	Apx
ATC level 5	A10BB09
ATC level 4	A10BB
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Sandoz Pty Ltd, Servier Laboratories Australia Pty Ltd, Alphapharm Pty Ltd, Lupin Australia Pty Limited +7 more
Registrations on file	22
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$3.92

AEMP

Dispensed (DPMQ)

A$22.68

incl. fees

Pack

gliclazide 60 mg modified release tablet, 60

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.76

Drug Tariff

🇮🇹 IT

€7.37

Retail price

🇫🇷 FR

€2.95

Retail price

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · gliclazide-80-mg-tablets-crescent-pharma-uk

TGA Section 19A: overseas-registered 'Gliclazide 80 mg Tablets (Crescent Pharma, UK)' approved for import and supply in Australia during a shortage. Origin: Crescent Pharma, UK. Expires Sept 2026. Verify on TGA Section 19A approvals ↗

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

Cosma SPA

Manufacturing countries: Italy · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇦🇺

Australia

TGA · 1h ago

Critical

🇨🇦

Canada

HC · 1h ago

High

🇧🇪

FAMHP · 2h ago

Medium

🇮🇹

Italy

AIFA · 7h ago

Medium

🇬🇷

EOF · 1mo ago

Resolved

🇳🇱

Netherlands

CBG-MEB · 1mo ago

Medium

Verified timeline regulator events

🇦🇺 19 Oct 2026

high reported

🇮🇹 15 Aug 2026

medium reported

🇦🇺 22 June 2026

critical reported

🇦🇺 24 Apr 2026

Shortage resolved

🇦🇺 17 Apr 2026

low reported

🇬🇷 14 Apr 2026

Shortage resolved

Sources official regulators

🇨🇦

verified 1h ago

verify ↗

🇦🇺

TGA

verified 1h ago

verify ↗

🇧🇪

FAMHP

verified 2h ago

verify ↗

🇮🇹

AIFA

verified 7h ago

verify ↗

🇬🇷

EOF

verified 1mo ago

verify ↗

🇳🇱

CBG-MEB

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders22 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
Arx	80 mg	—	🇦🇺 AU	—	Active
Sandoz Mr	30 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Sandoz Mr	60 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Diamicron	60 mg	—	🇦🇺 AU	Servier Laboratories Australia Pty Ltd	Active
Ardix Gliclazide	60 mg	—	🇦🇺 AU	Servier Laboratories Australia Pty Ltd	Active
Mr Viatris	30 mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Lupin Mr	60 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
Gh Mr	60 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
Gliclazide Tablets Bp	80MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Gliclazide Accord	30MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Gliclazide Accord	60MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Gliclazide Accord-Uk	30MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Gliclazide Accord-Uk	60MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
GLICLAZIDE 80MG TABLETS	80MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Gliclazide Teva	30 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active

+7 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.