Metronidazole shortage — AU supply status & alternatives

Metronidazole

—

🇦🇺 AUST R 384574 · Interpharma Pty Ltd

In shortage · Australia

WHO Essential Medicine

Metrogyl

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇺🇸 US🇪🇸 ES🇧🇪 BE🇬🇷 GR🇮🇪 IE🇳🇱 NL

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$2.50DPMQ A$17.10details →

• Can I substitute?

No pathway on record

prescriber decision required

Product attributes reference data we hold

Active ingredient (INN)	Metronidazole
Brand names	Metrogyl
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Interpharma Pty Ltd, Medicianz Healthcare Pty Ltd, BAXTER HEALTHCARE LIMITED, ACCORD-UK LIMITED +13 more
Registrations on file	26
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

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

2 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.

High concentration risk

Corden Pharma Bergamo SPAUnichem Laboratories LTD

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

Shortage status by regulator official notices

🇦🇺

Australia

TGA · just now

Critical

🇺🇸

United States

FDA · just now

High

🇨🇦

Canada

Medsafe NZ Full · 3mo ago

High

🇧🇪

FAMHP · 3mo ago

High

🇬🇷

EOF · 1d ago

Medium

🇳🇴

Norway

NOMA · 2mo ago

Resolved

🇪🇸

Spain

AEMPS · 2mo ago

Medium

🇮🇪

Ireland

HPRA · 3mo ago

Medium

Recalls official enforcement reports

🇺🇸

Metronidazole

Sentara Infusion Services · Dec 2022

Class IIdetails ↗

🇺🇸

Metronidazole

Synergy Rx · Feb 2017

Class IIdetails ↗

🇺🇸

Metronidazole

Safecor Health, LLC · July 2016

Class IIdetails ↗

🇺🇸

METRONIDAZOLE

Baxter Healthcare Corp. · Jan 2016

Class Idetails ↗

🇺🇸

METRONIDAZOLE

Baxter Healthcare Corp. · May 2013

Class IIdetails ↗

Sources official regulators

🇺🇸

FDA

verified just now

verify ↗

🇦🇺

TGA

verified just now

verify ↗

🇬🇷

EOF

verified 1d ago

verify ↗

🇳🇿

Medsafe NZ Full

verified 3mo ago

verify ↗

🇳🇴

NOMA

verified 2mo ago

verify ↗

🇪🇸

AEMPS

verified 2mo ago

verify ↗

🇮🇪

HPRA

verified 3mo ago

verify ↗

🇳🇱

CBG-MEB

verified 3mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders26 registrations · 17 MA holders

Product	Strength	Form	Market	MA holder	Status
Noridem	500mg	—	🇦🇺 AU	Interpharma Pty Ltd	Active
Medicianz	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Medsurge	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
METRONIDAZOLE 500MG/100ML INTRAVENOUS INFUSION	500MG	infusion	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Metronidazole Tablets Bp	200MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Metronidazole Tablets Bp	400MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
METRONIDAZOLE 200MG/5ML ORAL SUSPENSION	200MG	suspension	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
METRONIDAZOLE 500MG/100ML SOLUTION FOR INFUSION	500MG	solution	🇬🇧 GB	B BRAUN MELSUNGEN AG	Active
Metrolyl Suppositories	500MG	metrolyl	🇬🇧 GB	SANDOZ LIMITED	Active
Metrolyl Suppositories	1G	metrolyl	🇬🇧 GB	SANDOZ LIMITED	Active
Metrolyl	200MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
Metrolyl	400MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
METRONIDAZOLE 200MG TABLETS BP	200MG	tablet	🇬🇧 GB	PHARMVIT LIMITED	Active
METRONIDAZOLE 400MG TABLETS BP	400MG	tablet	🇬🇧 GB	PHARMVIT LIMITED	Active
Metronidazole 0.75% W/W Gel	0.75%	gel	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active

+11 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.