Zonisamide shortage — IT supply status & alternatives

Zonisamide

—

🇦🇺 AUST R 125869 · Amdipharm Mercury Australia Pty Ltd

In supply · Australia

Zonegran

In supply · 🇦🇺 Australia · short in🇮🇹 IT

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$10.41DPMQ A$36.08details →

✓ 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)

Brand names	Zonegran

Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	Amdipharm Mercury Australia Pty Ltd, NCS HealthCare of KY, LLC dba Vangard Labs, UNICHEM PHARMACEUTICALS (USA), INC.

Registrations on file	9

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$10.41

AEMP

Dispensed (DPMQ)

A$36.08

incl. fees

Pack

zonisamide 25 mg capsule, 56

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£4.87

Drug Tariff

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

11 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

Sumitomo Pharma CO LTDDipharma Francis SrlAlivus Life Sciences LTDWockhardt LTDZydus Lifesciences LTDSun Pharmaceutical Industries LTD+5 more

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

Recalls official enforcement reports

🇺🇸

ZONISAMIDE

Glenmark Pharmaceuticals Inc., USA · Apr 2022

Class IIdetails ↗

🇺🇸

ZONISAMIDE

Glenmark Pharmaceuticals Inc., USA · Apr 2022

Class IIdetails ↗

🇺🇸

ZONISAMIDE

Glenmark Pharmaceuticals Inc., USA · Apr 2022

Class IIdetails ↗

🇺🇸

Zonisamide

Direct Rx · Sept 2021

Class IIdetails ↗

🇺🇸

ZONISAMIDE

Glenmark Pharmaceuticals Inc., USA · Aug 2021

Class IIdetails ↗

🇺🇸

ZONISAMIDE

Glenmark Pharmaceuticals Inc., USA · Aug 2021

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
ZONEGRAN zonisamide	25mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
ZONEGRAN zonisamide	50mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
ZONEGRAN zonisamide	100mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
Apotex	25 mg	—	🇦🇺 AU	—	Active
Apotex	100 mg	—	🇦🇺 AU	—	Active
Apotex	50 mg	—	🇦🇺 AU	—	Active
zonisamide	100mg/1	capsule	🇺🇸 US	NCS HealthCare of KY, LLC dba Vangard Labs	Active
Zonisamide	25mg/1	capsule	🇺🇸 US	UNICHEM PHARMACEUTICALS (USA), INC.	Active
Zonisamide	50mg/1	capsule	🇺🇸 US	UNICHEM PHARMACEUTICALS (USA), INC.	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.