Carbamazepine shortage — US supply status & alternatives

Carbamazepine

ATC N03AF01

🇦🇺 AUST R 434691 · Novartis Pharmaceuticals Australia Pty Ltd

In supply · Australia

WHO Essential Medicine

EpitolCarbamazepina Zentiva

In supply · 🇦🇺 Australia · short in🇩🇪 DE🇺🇸 US🇨🇦 CA🇳🇱 NL

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$4.85DPMQ A$34.72details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

Best alternative

Product attributes reference data we hold

Active ingredient (INN)	Carbamazepine
Brand names	Epitol, Carbamazepina Zentiva
ATC level 5	N03AF01
ATC level 4	N03AF
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Novartis Pharmaceuticals Australia Pty Ltd, MILPHARM LIMITED, MEDREICH PLC, CRESCENT PHARMA LIMITED +5 more
Registrations on file	27
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$4.85

AEMP

Dispensed (DPMQ)

A$34.72

incl. fees

Pack

carbamazepine 100 mg tablet, 100

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$1.20

Acquisition

🇫🇷 FR

€1.88

Retail price

🇮🇹 IT

€3.08

Retail price

🇪🇸 ES

€7.96

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

Siegfried Evionnaz SATapi Nl BVTaro Pharmaceutical Industries LTDFis Fabbrica Italiana Sintetici SPAJubilant Biosys LTDAmoli Organics (A Division Of Umedica Laboratories PVT Ltd)+3 more

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

Recalls official enforcement reports

🇺🇸

CARBAMAZEPINE

Amerisource Health Services LLC · Sept 2025

Class IIdetails ↗

🇺🇸

CARBAMAZEPINE

Torrent Pharma Inc. · Dec 2021

Class IIdetails ↗

🇺🇸

CARBAMAZEPINE

The Harvard Drug Group · Aug 2021

Class IIdetails ↗

🇺🇸

Carbamazepine

RemedyRepack Inc. · June 2020

Class IIdetails ↗

🇺🇸

CARBAMAZEPINE

Torrent Pharma Inc. · May 2020

Class IIdetails ↗

🇺🇸

Carbamazepine

American Health Packaging · Aug 2019

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
AVLOIRE carbamazepine	200 mg	—	🇦🇺 AU	Novartis Pharmaceuticals Australia Pty Ltd	Active
AVLOIRE carbamazepine	100 mg	—	🇦🇺 AU	Novartis Pharmaceuticals Australia Pty Ltd	Active
Carbamazepine Milpharm	200 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Carbamazepine Milpharm	400 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Carbamazepine Medreich	100MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
Carbamazepine Medreich	200MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
Carbamazepine Medreich	400MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
Carbamazepine Crescent	100 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Carbamazepine Crescent	200 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Carbamazepine Crescent	400 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Carbamazepine Medreich	200 MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
Carbamazepine Medreich	400 MG	tablet	🇬🇧 GB	MEDREICH PLC	Active
Carbamazepine Sun	100 MG	suspension	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
Carbamazepine Essential Pharma	125MG	carbamazepine	🇬🇧 GB	Essential Pharma Limited	Active
Carbamazepine Essential Pharma	250MG	carbamazepine	🇬🇧 GB	Essential Pharma Limited	Active

+12 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.