Clobazam shortage — US supply status & alternatives

Clobazam

ATC N05BA09

🇦🇺 AUST R 316683 · Pharmacor Pty Ltd

In supply · Australia

Epaclob

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🌐 CO🇳🇱 NL

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

ATC level 5
Active ingredient (INN)	Clobazam
Brand names	Epaclob

ATC level 4	N05BA

Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	Pharmacor Pty Ltd, MARTINDALE PHARMACEUTICALS LIMITED, MILPHARM LIMITED, ACCORD HEALTHCARE LIMITED +11 more

Registrations on file	25

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇬🇧 GB

£5.30

Drug Tariff

🇺🇸 US

US$0.48

Acquisition

🇪🇸 ES

€3.90

Retail price

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

9 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

Euroapi Germany GMBHFis Fabbrica Italiana Sintetici SPACambrex Profarmaco Milano SrlPiramal Pharma LTDHonour Lab LTDCentaur Pharmaceuticals Private LTD+3 more

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

Recalls official enforcement reports

🇺🇸

CLOBAZAM

Amerisource Health Services LLC · Jan 2025

Class IIdetails ↗

🇺🇸

CLOBAZAM

Amerisource Health Services LLC · Dec 2024

Class IIdetails ↗

🇺🇸

CLOBAZAM

Micro Labs Limited · Feb 2024

Class IIdetails ↗

🇺🇸

Clobazam Tablets

Breckenridge Pharmaceutical, Inc · Mar 2023

Class IIdetails ↗

🇺🇸

Clobazam Tablets

Breckenridge Pharmaceutical, Inc · Mar 2023

Class IIdetails ↗

🇺🇸

Clobazam Oral Suspension

VistaPharm, Inc. · Jan 2022

Class IIdetails ↗

Sources official regulators

🇺🇸

FDA MedWatch

verified 2h ago

verify ↗

🇨🇦

verified 3h ago

verify ↗

🇳🇱

CBG-MEB

verified 8h ago

verify ↗

🇺🇸

FDA-FE

verified 9h ago

verify ↗

🇮🇹

AIFA

verified 10h ago

verify ↗

🌐

INVIMA

verified 22h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 15 MA holders

Product	Strength	Form	Market	MA holder	Status
CLOBIUM clobazam	10 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Pharmacor	10 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Clobazam Martindale Pharma	5MG	suspension	🇬🇧 GB	MARTINDALE PHARMACEUTICALS LIMITED	Active
Clobazam Martindale Pharma	10MG	suspension	🇬🇧 GB	MARTINDALE PHARMACEUTICALS LIMITED	Active
Clobazam Milpharm	10 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Clobazam Accord	10MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Clobazam Crescent	10 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Clobazam Crescent	20 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
CLOBAZAM 10 MG TABLETS	10 MG	tablet	🇬🇧 GB	BROWN & BURK UK LIMITED	Active
CLOBAZAM 20 MG TABLETS	20 MG	tablet	🇬🇧 GB	BROWN & BURK UK LIMITED	Active
Clobazam Wockhardt	1MG	suspension	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
Clobazam Wockhardt	2MG	suspension	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
Clobazam Thame	5MG	suspension	🇬🇧 GB	SYRI LIMITED	Active
Clobazam Thame	10MG	suspension	🇬🇧 GB	SYRI LIMITED	Active
Clobazam Essential Pharmaceuticals	1 MG	suspension	🇬🇧 GB	ESSENTIAL PHARMACEUTICALS 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.