Lansoprazole shortage — AU supply status & alternatives

Lansoprazole

ATC A02BC03

🇦🇺 AUST R 324704

In shortage · Australia

WHO Essential Medicine

Apo-Lansoprazole Odt

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇪🇸 ES🇳🇿 NZ🇧🇪 BE

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$3.42DPMQ A$21.68details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Omeprazole

Closely related · pharmacological alternative

◷ Expected back

Jan 2027

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Lansoprazole
Brand names	Apo-Lansoprazole Odt
ATC level 5	A02BC03
ATC level 4	A02BC
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, TEVA UK LIMITED, Generics (UK) Limited, SUN PHARMA UK LIMITED +3 more
Registrations on file	14
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$3.42

AEMP

Dispensed (DPMQ)

A$21.68

incl. fees

Pack

lansoprazole 15 mg orally disintegrating tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.46

Acquisition

🇬🇧 GB

£0.76

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.

How long have past shortages lasted? from 7 resolved events

◷

2–8 months

Historical pattern from resolved shortage records — not a prediction of this event.

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

22 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

Wockhardt LTDMacleods Pharmaceuticals LTDChromo Laboratories India Private LTDTapi Nl BVUnion Quimico Farmaceutica SA (Uquifa Sa)Moehs Iberica Sl+16 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

May 2024

Latest approval

Shortage status by regulator official notices

🇦🇺

Australia

TGA · 3h ago

Critical

🇳🇿

New Zealand

Pharmac · 8h ago

High

🇨🇦

Canada

HC · 2h ago

Medium

🇧🇪

FAMHP · 4h ago

Medium

🇪🇸

Spain

AEMPS · 4mo ago

Medium

Recalls official enforcement reports

🇺🇸

LANSOPRAZOLE

Dr. Reddy's Laboratories, Inc. · July 2022

Class IIdetails ↗

🇺🇸

LANSOPRAZOLE

Dr. Reddy's Laboratories, Inc. · July 2022

Class IIdetails ↗

🇺🇸

LANSOPRAZOLE

Dr. Reddy's Laboratories, Inc. · Apr 2022

Class IIdetails ↗

🇺🇸

LANSOPRAZOLE

Dr. Reddy's Laboratories, Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

LANSOPRAZOLE

Dr. Reddy's Laboratories, Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

LANSOPRAZOLE

Zydus Pharmaceuticals (USA) Inc · Dec 2020

Class IIdetails ↗

Verified timeline regulator events

🇦🇺 14 Aug 2026

medium reported

🇳🇿 12 June 2026

high reported

🇨🇦 11 June 2026

medium reported

🇦🇺 5 June 2026

high reported

🇧🇪 5 June 2026

medium reported

🇦🇺 29 May 2026

Shortage resolved

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇦🇺

TGA

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 4h ago

verify ↗

🇳🇿

Pharmac

verified 8h ago

verify ↗

🇪🇸

AEMPS

verified 4mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders14 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Noumed	30 mg	—	🇦🇺 AU	—	Active
LANSOPRAZOLE 15 MG GASTRO-RESISTANT CAPSULES	15 MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
LANSOPRAZOLE 30MG GASTRO-RESISTANT CAPSULES	30MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
LANSOPRAZOLE 30 MG GASTRO-RESISTANT CAPSULES	30 MG	capsule	🇬🇧 GB	TEVA UK LIMITED	Active
LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS	15 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
LANSOPRAZOLE 30 MG ORODISPERSIBLE TABLETS	30 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS.	15 MG	tablet	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
LANSOPRAZOLE 15 MG ORO-DISPERSIBLE TABLETS	15 MG	tablet	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
LANSOPRAZOLE 30 MG ORO-DISPERSIBLE TABLETS	30 MG	tablet	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
LANSOPRAZOLE 15MG GASTRO-RESISTANT CAPSULES	15MG	capsule	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
LANSOPRAZOLE 15MG ORODISPERSIBLE TABLETS	15MG	tablet	🇬🇧 GB	LUPIN HEALTHCARE (UK) LIMITED	Active
LANSOPRAZOLE 30MG ORODISPERSIBLE TABLETS	30MG	tablet	🇬🇧 GB	LUPIN HEALTHCARE (UK) LIMITED	Active
Lansoprazole	15mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Lansoprazole	30mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active

Mederti Drug Report

Generated 1 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.