Trifarotene shortage — BE supply status & alternatives

Trifarotene

—

🇦🇺 AUST R 332220 · Galderma Australia Pty Ltd

Anticipated · Australia

Aklief

Anticipated · 🇦🇺 Australia & also short in🇧🇪 BE

Anticipated shortage

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

July 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Trifarotene
Brand names	Aklief
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper

Controlled substance	No

Marketing-authorisation holders	Galderma Australia Pty Ltd

Registrations on file	1

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

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

4 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

Has Healthcare Advanced Synthesis SAOlon SPATaro Pharmaceutical Industries LTDMaithri Drugs Private LTD

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

Verified timeline regulator events

🇧🇪 28 June 2026

medium reported

🇧🇪 24 June 2026

medium reported

🇦🇺 18 June 2026

low reported

🇦🇺 16 June 2026

Shortage resolved

🇧🇪 1 June 2026

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders1 registration · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
AKLIEF trifarotene	50 microgram	—	🇦🇺 AU	Galderma Australia Pty Ltd	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.