Stiripentol shortage — CA supply status & alternatives

Stiripentol

—

🇦🇺 AUST R 280985

Anticipated · Australia

DIACOMIT stiripentol

Anticipated · 🇦🇺 Australia & also short in🇨🇦 CA

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$293.00DPMQ A$651.12details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Oct 2026

Sponsor est. via TGA

Product attributes reference data we hold

Brand names	DIACOMIT stiripentol

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

Controlled substance	No

Registrations on file	2

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$293.00

AEMP

Dispensed (DPMQ)

A$651.12

incl. fees

Pack

stiripentol 250 mg capsule, 60

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

5 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.

Moderate concentration risk

Metrochem Api Private LTDSs Pharma LLCMsn Life Sciences Private LTDAlp Pharm Beijing CO LTDTorrent Pharmaceuticals LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations

Product	Strength	Form	Market	MA holder	Status
DIACOMIT stiripentol	250 mg	—	🇦🇺 AU	—	Active
DIACOMIT stiripentol	500 mg	—	🇦🇺 AU	—	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.