Amisulpride shortage — AU supply status & alternatives

Amisulpride

ATC N05AL05

In shortage · Australia

SULPRIX amisulpride

In declared shortage · 🇦🇺 Australia & also short in🇮🇹 IT🇧🇪 BE

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$4.75DPMQ A$19.35details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Aug 2026

Sponsor est. via TGA

Product attributes reference data we hold

Brand names	SULPRIX amisulpride

ATC level 5	N05AL05

ATC level 4	N05AL

Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper

Controlled substance	No

Marketing-authorisation holders	DHP HEALTHCARE LIMITED, ACCORD-UK LIMITED, Generics (UK) Limited, MILPHARM LIMITED +1 more

Registrations on file	11

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$4.75

AEMP

Dispensed (DPMQ)

A$19.35

incl. fees

Pack

amisulpride 100 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£3.17

Drug Tariff

🇮🇹 IT

€24.63

Retail price

🇫🇷 FR

€41.79

Retail price

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

Icrom SrlCosma SPA

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

Verified timeline regulator events

🇮🇹 15 Sept 2026

medium reported

🇮🇹 31 Aug 2026

medium reported

🇧🇪 1 July 2026

medium reported

🇦🇺 29 Apr 2026

critical reported

🇦🇺 16 Apr 2026

Shortage resolved

🇦🇺 26 Feb 2026

Shortage resolved

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders11 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
AMISULPRIDE 50 MG TABLETS	50 MG	tablet	🇬🇧 GB	DHP HEALTHCARE LIMITED	Active
AMISULPRIDE 100 MG TABLETS	100 MG	tablet	🇬🇧 GB	DHP HEALTHCARE LIMITED	Active
AMISULPRIDE 200 MG TABLETS	200 MG	tablet	🇬🇧 GB	DHP HEALTHCARE LIMITED	Active
AMISULPRIDE 400 MG TABLETS	400 MG	tablet	🇬🇧 GB	DHP HEALTHCARE LIMITED	Active
AMISULPRIDE 50MG TABLETS	50MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AMISULPRIDE 100MG TABLETS	100MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AMISULPRIDE 200MG TABLETS	200MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AMISULPRIDE 400MG FILM-COATED TABLETS	400MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AMISULPRIDE 400 MG FILM-COATED TABLETS	400 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
AMISULPRIDE 400MG TABLETS	400MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
AMISULPRIDE 100MG/ML ORAL SOLUTION	100MG	solution	🇬🇧 GB	FOCUS PHARMACEUTICALS LIMITED	Active

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.