Doxorubicin Hydrochloride shortage — BE supply status & alternatives

Doxorubicin Hydrochloride

ATC L01DB01

🇦🇺 AUST R 15407 · Pfizer Australia Pty Ltd

In supply · Australia

Zolsketil Pegylated Liposomal

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$138.42details →

✓ 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

Active ingredient (INN)	Doxorubicin Hydrochloride
Brand names	Zolsketil Pegylated Liposomal
ATC level 5	L01DB01
ATC level 4	L01DB
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper
Controlled substance	No
Marketing-authorisation holders	Medac Gesellschaft fuer klinische Spezialpraeparate mbH, PFIZER LABORATORIES DIV PFIZER INC, Pfizer Australia Pty Ltd
Registrations on file	3
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$138.42

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

doxorubicin hydrochloride (as pegylated liposomal) 20 mg/10 mL injection, 10 mL vial

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

10 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 LTDPharmacia And Upjohn CO Wholly Owned Sub Pfizer INCMicrobiopharm Japan CO LTDMeiji Seika Pharma CO LTDTapi Nl BVSynbias Pharma AG+4 more

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

Recalls official enforcement reports

🇺🇸

DOXORUBICIN HYDROCHLORIDE

SUN PHARMACEUTICAL INDUSTRIES INC · May 2026

Class Idetails ↗

🇺🇸

DOXIL

Baxter Healthcare Corporation · Aug 2023

Class IIdetails ↗

🇺🇸

DOXORUBICIN HYDROCHLORIDE

Fresenius Kabi USA, LLC · Nov 2020

Class IIIdetails ↗

🇺🇸

DOXORUBICIN HYDROCHLORIDE

Sun Pharmaceutical Industries, Inc. · Jan 2018

Class IIdetails ↗

Verified timeline regulator events

🇧🇪 15 June 2026

medium reported

🇧🇪 29 May 2026

medium reported

🇺🇸 12 May 2026

high reported

🇨🇦 6 May 2026

high reported

🇧🇪 26 Feb 2026

high reported

🇨🇦 1 May 2025

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
DOXORUBICIN HYDROCHLORIDE 2 MG/ML SOLUTION FOR INFUSION	2 MG	solution	🇬🇧 GB	Medac Gesellschaft fuer klinische Spezialpraeparate mbH	Active
Doxorubicin Hydrochloride	2mg/mL	injection	🇺🇸 US	PFIZER LABORATORIES DIV PFIZER INC	Active
ADRIAMYCIN doxorubicin hydrochloride	10mg	—	🇦🇺 AU	Pfizer 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.