Quetiapine shortage — EU supply status & alternatives

Quetiapine

—

🇦🇺 AUST R 346814 · Accord Healthcare Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🌐 EU🇨🇦 CA🇮🇹 IT🇧🇪 BE🇬🇷 GR🇳🇱 NL🇵🇹 PT

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$4.00DPMQ A$18.60details →

✓ 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

Active ingredient (INN)	Quetiapine
Therapeutic category	Auto-created by CBG-MEB (Netherlands) scraper
Controlled substance	No
Marketing-authorisation holders	Accord Healthcare Pty Ltd, Sandoz Pty Ltd
Registrations on file	30
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$4.00

AEMP

Dispensed (DPMQ)

A$18.60

incl. fees

Pack

quetiapine 25 mg tablet, 60

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.05

Drug Tariff

🇺🇸 US

US$0.17

Acquisition

🇫🇷 FR

€28.48

Retail price

🇮🇹 IT

€60.00

Retail price

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

38 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

Iol Chemicals And Pharmaceuticals LTDSynthimed Labs Private LTDMacleods Pharmaceuticals LTDCohance Lifesciences LTDLupin LTDRaks Pharma PVT LTD+32 more

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

Shortage status by regulator official notices

🌐

EMA · 3d ago

High

🇨🇦

Canada

HC · just now

Medium

🇮🇹

Italy

AIFA · 1d ago

Medium

🇵🇹

INFARMED · 1d ago

Medium

🇬🇷

EOF · 1d ago

Medium

🇧🇪

FAMHP · 1d ago

Medium

🇳🇱

Netherlands

CBG-MEB · 2d ago

Medium

Recalls official enforcement reports

🇺🇸

QUETIAPINE

The Harvard Drug Group · Feb 2020

Class IIIdetails ↗

🇺🇸

QUETIAPINE

The Harvard Drug Group · Feb 2020

Class IIIdetails ↗

🇺🇸

QUETIAPINE

The Harvard Drug Group · Feb 2020

Class IIIdetails ↗

🇺🇸

QUETIAPINE

The Harvard Drug Group · Feb 2020

Class IIIdetails ↗

🇺🇸

QUETIAPINE

Ascend Laboratories LLC · Nov 2018

Class IIdetails ↗

Sources official regulators

🇨🇦

verified just now

verify ↗

🇮🇹

AIFA

verified 1d ago

verify ↗

🇵🇹

INFARMED

verified 1d ago

verify ↗

🇬🇷

EOF

verified 1d ago

verify ↗

🇧🇪

FAMHP

verified 1d ago

verify ↗

🇳🇱

CBG-MEB

verified 2d ago

verify ↗

🌐

EMA

verified 3d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
SERAPINE XR quetiapine	50 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Sandoz XR	150 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SERAPINE XR quetiapine	150 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SERAPINE XR quetiapine	200 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SEROTIAPINE XR quetiapine	300 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SYQUET XR quetiapine	150 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Sandoz XR	50 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SEROTIAPINE XR quetiapine	150 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Sandoz XR	200 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Sandoz XR	300 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SYQUET XR quetiapine	300 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Sandoz XR	400 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SYQUET XR quetiapine	400 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SERAPINE XR quetiapine	300 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
SEROTIAPINE XR quetiapine	400 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active

+15 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.