Clozapine shortage — AU supply status & alternatives

Clozapine

ATC N05AH02

🇦🇺 AUST R 310800 · Pharmacor Pty Ltd

In shortage · Australia

Clozapina StadaClozapina AccordCLOPINE SUSPENSION clozapine

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇧🇪 BE🌐 MY

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$27.75details →

✓ Can I substitute?

Yes — approved substitute available

TGA s19A · versacloz-clozapine-50-mgml-oral-suspension-trupharma-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Jan 2027

Product attributes reference data we hold

Active ingredient (INN)	Clozapine
Brand names	Clozapina Stada, Clozapina Accord, CLOPINE SUSPENSION clozapine
ATC level 5	N05AH02
ATC level 4	N05AH
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Pharmacor Pty Ltd, VIATRIS PRODUCTS LIMITED
Registrations on file	17
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$27.75

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

clozapine 25 mg tablet, 100

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$4.56

Acquisition

🇮🇹 IT

€5.38

Retail price

🇫🇷 FR

€1.03

Retail price

🇪🇸 ES

€14.17

Retail price

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · versacloz-clozapine-50-mgml-oral-suspension-trupharma-usa

TGA Section 19A: overseas-registered 'VERSACLOZ clozapine 50 mg/mL oral suspension (TruPharma, USA)' approved for import and supply in Australia during a shortage. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

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

12 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

Global Calcium Private LTDCambrex Profarmaco Milano SrlMatrix Pharmacorp Private LTDMedichem SAShanghai Zhongxi Sunve Pharmaceutical CO LTDWuhan Shiji Pharmaceutical CO LTD+6 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders17 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
Pharmacor	25 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Akm	25 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Pharmacor	200 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
CLOZITOR clozapine	200 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Pharmacor	50 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Akm	50 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
CLOZITOR clozapine	50 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Pharmacor	100 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Akm	100 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
CLOZITOR clozapine	100 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Akm	200 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
CLOZITOR clozapine	25 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Clozapine Viatris	25 MG	tablet	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
Clozapine Viatris	100 MG	tablet	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active
Clozapine Viatris	200 MG	tablet	🇬🇧 GB	VIATRIS PRODUCTS LIMITED	Active

+2 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.