Clarithromycin shortage — IE supply status & alternatives

Clarithromycin

ATC J01FA09

🇦🇺 AUST R 408831 · Sandoz Pty Ltd

Anticipated · Australia

ClaripenBiaxin XlClarithromycineClaripen Granules ForClaritromicina Zentiva

Anticipated · 🇦🇺 Australia & also short in🇨🇦 CA🇮🇪 IE

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$3.25DPMQ A$17.85details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Clarithromycin
Brand names	Claripen, Biaxin Xl, Clarithromycine, Claripen Granules For, Claritromicina Zentiva
ATC level 5	J01FA09
ATC level 4	J01FA
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No
Marketing-authorisation holders	Sandoz Pty Ltd, HAMELN PHARMA LTD, KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO, SANDOZ LIMITED +4 more
Registrations on file	15
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$3.25

AEMP

Dispensed (DPMQ)

A$17.85

incl. fees

Pack

clarithromycin 250 mg tablet, 14

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£14.38

Drug Tariff

🇺🇸 US

US$0.34

Acquisition

🇫🇷 FR

€9.46

Retail price

🇪🇸 ES

€4.68

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.

How long have past shortages lasted? from 1 resolved event

◷

~2 months

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

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

8 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

Synthimed Labs Private LTDHec Pharm CO LTDZhejiang Better Pharmaceuticals CO LTDCentury Pharmaceuticals LTDTapi Nl BVAlembic Pharmaceuticals LTD+2 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

May 2023

Latest approval

Shortage status by regulator official notices

🇦🇺

Australia

TGA Recalls · 3mo ago

High

🇬🇧

United Kingdom

MHRA · 1mo ago

Resolved

🇨🇦

Canada

HC · 2h ago

Medium

🇮🇪

Ireland

HPRA · 1mo ago

Medium

🇸🇬

Singapore

HSA-SG · 4mo ago

Resolved

Verified timeline regulator events

🇮🇪 31 Jan 2026

medium reported

🇨🇦 29 Oct 2025

medium reported

🇨🇦 18 Aug 2025

Shortage resolved

🇦🇺 24 Apr 2025

high reported

🇸🇬 19 Mar 2025

Shortage resolved

🇬🇧 22 May 2024

Shortage resolved

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇦🇺

TGA Recalls

verified 3mo ago

verify ↗

🇬🇧

MHRA

verified 1mo ago

verify ↗

🇮🇪

HPRA

verified 1mo ago

verify ↗

🇸🇬

HSA-SG

verified 4mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders15 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
ESOMEPRAZOLE SANDOZ Hp7 amoxicillin	500 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
CLARITHROMYCIN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION	500 MG	solution	🇬🇧 GB	HAMELN PHARMA LTD	Active
CLARITHROMYCIN 250 MG FILM-COATED TABLETS	250 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
CLARITHROMYCIN 500 MG FILM-COATED TABLETS	500 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
CLARITHROMYCIN 125MG/5ML SUSPENSION	125MG	suspension	🇬🇧 GB	SANDOZ LIMITED	Active
CLARITHROMYCIN 250MG/5ML SUSPENSION	250MG	suspension	🇬🇧 GB	SANDOZ LIMITED	Active
CLARITHROMYCIN 250MG TABLETS	250MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
CLARITHROMYCIN 500MG TABLETS	500MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
CLARITHROMYCIN 500 MG, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION	500 MG	solution	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
CLARITHROMYCIN 250MG FILM-COATED TABLETS	250MG	tablet	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
CLARITHROMYCIN 500MG FILM-COATED TABLETS	500MG	tablet	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
CLARITHROMYCIN 250MG FILM COATED TABLETS	250MG	tablet	🇬🇧 GB	STRANDHAVEN LIMITED	Active
CLARITHROMYCIN 500MG FILM COATED TABLETS	500MG	tablet	🇬🇧 GB	STRANDHAVEN LIMITED	Active
CLARITHROMYCIN 250 MG FILM COATED TABLETS	250 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
CLARITHROMYCIN 500 MG FILM COATED TABLETS	500 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	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.