Daunorubicin shortage — AU supply status & alternatives

Daunorubicin

ATC L01DB02

🇦🇺 AUST R 363250

In shortage · Australia

Pfizer Pfizer DAUNORUBICIN

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇳🇿 NZ

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

• Can I substitute?

No pathway on record

prescriber decision required

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes

Active ingredient (INN)	Daunorubicin
Brand names	Pfizer, Pfizer DAUNORUBICIN
ATC level 5	L01DB02
ATC level 4	L01DB
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Pfizer Australia Pty Ltd, ZENTIVA PHARMA UK LIMITED, HIKMA PHARMACEUTICALS USA INC., HIKMA CANADA LIMITED +2 more
Registrations on file	8
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.

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

7 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

Zhejiang Hisun Pharmaceutical CO LTDMicrobiopharm Japan CO LTDMeiji Seika Pharma CO LTDTapi Nl BVOlon SPADzd (Heze) Pharmaceutical CO LTD+1 more

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

Verified timeline regulator events

🇳🇿 14 May 2026

high reported

🇳🇿 15 Apr 2026

high reported

🇳🇿 28 Jan 2026

high reported

🇨🇦 31 Oct 2025

high reported

🇦🇺 25 Apr 2025

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders8 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
VYXEOS daunorubicin	44 mg	—	🇦🇺 AU	—	Active
Pfizer	18.7 mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
DAUNORUBICIN	—	daunorubicin	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
Daunorubicin Hydrochloride	5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Pfizer DAUNORUBICIN	20mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
Daunorubicin Hydrochloride	—	solution	🇨🇦 CA	HIKMA CANADA LIMITED	Active
DAUNORUBICIN INJECTABLE SOLUTION	—	solution	🇨🇦 CA	GENERIC MEDICAL PARTNERS INC	Active
Daunorubicin Hydrochloride For	—	solution	🇨🇦 CA	TEVA CANADA LIMITED	Cancelled

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.