Lurasidone Hydrochloride shortage — CA supply status & alternatives

Lurasidone Hydrochloride

—

🇦🇺 AUST R 324801 · Servier Laboratories Australia Pty Ltd

In supply · Australia

Latomno®

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇬🇷 GR

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$14.52DPMQ A$29.50details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Lurasidone Hydrochloride

Brand names	Latomno®

Therapeutic category	Auto-created by National Organisation for Medicines — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Servier Laboratories Australia Pty Ltd, Sandoz Pty Ltd, Pharmacor Pty Ltd, Lupin Australia Pty Limited +2 more

Registrations on file	28

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$14.52

AEMP

Dispensed (DPMQ)

A$29.50

incl. fees

Pack

lurasidone hydrochloride 40 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

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

32 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

Micro Labs LTDApitoria Pharma Private LTDSolara Active Pharma Sciences LTDZydus Lifesciences LTDDr Reddys Laboratories LTDAlivus Life Sciences LTD+26 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Aug 2024

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 3h ago

Medium

🇬🇷

EOF · 8h ago

Medium

Recalls official enforcement reports

🇺🇸

LURASIDONE HYDROCHLORIDE

SUN PHARMACEUTICAL INDUSTRIES INC · Jan 2024

Class IIdetails ↗

🇺🇸

LURASIDONE HYDROCHLORIDE

SUN PHARMACEUTICAL INDUSTRIES INC · Jan 2024

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 30 June 2026

medium reported

🇬🇷 2 Mar 2026

medium reported

🇨🇦 1 Mar 2026

medium reported

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇬🇷

EOF

verified 8h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders28 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
ARDIX LURASIDONE lurasidone hydrochloride	80 mg	—	🇦🇺 AU	Servier Laboratories Australia Pty Ltd	Active
MSN-LURASIDONE lurasidone hydrochloride	80 mg	—	🇦🇺 AU	—	Active
LURASIDONE SANDOZ lurasidone hydrochloride	40 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
LURASIDONE SANDOZ lurasidone hydrochloride	80 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
PHARMACOR LURASIDONE lurasidone hydrochloride	40 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
LURACOR lurasidone hydrochloride	80 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
LURACOR lurasidone hydrochloride	40 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
LURACOR lurasidone hydrochloride	20 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
LURASIDONE LAPL lurasidone hydrochloride	40 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
LURASIDONE LUPIN lurasidone hydrochloride	80 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
LURASIDONE LUPIN lurasidone hydrochloride	20 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
LURASIDONE LAPL lurasidone hydrochloride	20 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
LURASIDONE LAPL lurasidone hydrochloride	80 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
ALEMBIC LURASIDONE lurasidone hydrochloride	40 mg	—	🇦🇺 AU	Alembic Pharmaceuticals Australia Pty Ltd	Active
ALEMBIC LURASIDONE lurasidone hydrochloride	20 mg	—	🇦🇺 AU	Alembic Pharmaceuticals Australia Pty Ltd	Active

+13 more registrations on file

Mederti Drug Report

Generated 2 July 2026 · Australia market · 2 regulatory sources

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.