Midazolam shortage — US supply status & alternatives

Midazolam

ATC N05CD08

🇦🇺 AUST R 342690 · Clinect Pty Ltd

Limited supply · Australia

WHO Essential Medicine

Baxter

In declared shortage · 🇦🇺 Australia & also short in🇮🇹 IT🇺🇸 US🇨🇦 CA🌐 EU🇫🇷 FR🇧🇪 BE🇳🇱 NL🇳🇴 NO

Limited supply

Limited Availability

Reading today’s signals…

🇦🇺 AUAEMPA$24.54DPMQ A$39.96details →

Product attributes reference data we hold

Active ingredient (INN)	Midazolam
Brand names	Baxter
ATC level 5	N05CD08
ATC level 4	N05CD
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
WHO Essential Medicine	Yes · 1.3. Preoperative medication and sedation for short-term procedures (2023)
Controlled substance	No
Marketing-authorisation holders	Clinect Pty Ltd, ACCORD-UK LIMITED, HAMELN PHARMA LTD, AURUM PHARMACEUTICALS LIMITED +7 more
Registrations on file	25
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$24.54

AEMP

Dispensed (DPMQ)

A$39.96

incl. fees

Pack

midazolam 5 mg/mL injection, 10 x 1 mL ampoules

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£5.15

Drug Tariff

🇪🇸 ES

€2.65

Retail price

🇺🇸 US

US$0.68

Acquisition

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

6 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.

Moderate concentration risk

Wavelength Enterprises LTDCambrex Profarmaco Milano SrlCohance Lifesciences LTDSolara Active Pharma Sciences LTDGlobal Calcium Private LTDSupriya Lifescience LTD

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

Shortage status by regulator official notices

🇺🇸

United States

FDA · 1h ago

Critical

🇦🇺

Australia

TGA · 1h ago

Critical

🇮🇹

Italy

AIFA · 1d ago

Critical

🇫🇷

France

ANSM · 5h ago

High

🇨🇦

Canada

HC · 7h ago

High

🌐

EMA · 1d ago

High

🇳🇱

Netherlands

CBG-MEB · 2h ago

Medium

🇳🇴

Norway

NOMA · 3d ago

Medium

Recalls official enforcement reports

🇺🇸

Midazolam

RXQ Compounding LLC · June 2019

Class IIdetails ↗

🇺🇸

Midazolam

RXQ Compounding LLC · June 2019

Class IIdetails ↗

🇺🇸

Midazolam

Avella of Deer Valley, Inc. Store 38 · June 2018

Class IIdetails ↗

🇺🇸

Midazolam

Avella of Deer Valley, Inc. Store 38 · June 2018

Class IIdetails ↗

🇺🇸

Midazolam

Avella of Deer Valley, Inc. Store 38 · June 2018

Class IIdetails ↗

🇺🇸

Midazolam

Avella of Deer Valley, Inc. Store 38 · June 2018

Class IIdetails ↗

Sources official regulators

🇺🇸

FDA

verified 1h ago

verify ↗

🇦🇺

TGA

verified 1h ago

verify ↗

🇳🇱

CBG-MEB

verified 2h ago

verify ↗

🇮🇹

AIFA

verified 3h ago

verify ↗

🇫🇷

ANSM

verified 5h ago

verify ↗

🇨🇦

verified 7h ago

verify ↗

🌐

EMA

verified 1d ago

verify ↗

🇳🇴

NOMA

verified 3d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
ZYAMIS midazolam	2.5 mg	—	🇦🇺 AU	Clinect Pty Ltd	Active
ZYAMIS midazolam	5 mg	—	🇦🇺 AU	Clinect Pty Ltd	Active
ZYAMIS midazolam	7.5 mg	—	🇦🇺 AU	Clinect Pty Ltd	Active
ZYAMIS midazolam	10 mg	—	🇦🇺 AU	Clinect Pty Ltd	Active
MIDAZOLAM 5MG/ML SOLUTION FOR INJECTION OR INFUSION	5MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE	1 MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active
MIDAZOLAM 1MG/ML, SOLUTION FOR INJECTION/INFUSION	1MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
MIDAZOLAM 2MG/ML, SOLUTION FOR INJECTION/INFUSION	2MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
MIDAZOLAM 5MG/ML, SOLUTION FOR INJECTION/INFUSION	5MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
MIDAZOLAM 1MG/ML INJECTION	1MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Midazolam Injection Bp	2MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
MIDAZOLAM 1MG/ML INJECTION IN A PREFILLED SYRINGE	1MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
MIDAZOLAM 5MG/ML SOLUTION FOR INJECTION/INFUSION	5MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
MIDAZOLAM 2MG/ML SOLUTION FOR INJECTION/INFUSION	2MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
MIDAZOLAM 1MG/ML SOLUTION FOR INJECTION OR INFUSION	1MG	injection	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active

+10 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.