Mitomycin shortage — AU supply status & alternatives

Mitomycin

—

🇦🇺 AUST R 370360

In shortage · Australia

MITOCIN mitomycin

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇩🇪 DE🇺🇸 US🇧🇪 BE

Critical shortage

Reading today’s signals…

• Can I substitute?

No pathway on record

prescriber decision required

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

July 2026

Sponsor est. via TGA — may differ by brand

Product attributes reference data we hold

Active ingredient (INN)	Mitomycin
Brand names	MITOCIN mitomycin
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Omegapharm, MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, ACCORD HEALTHCARE LIMITED, HIKMA PHARMACEUTICALS USA INC. +1 more
Registrations on file	17
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

6 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

Zhejiang Hisun Pharmaceutical CO LTDTapi Nl BVConcord Biotech LTDChemwerth INCWuxi Fortune Pharmaceutical CO LTDHubei Honch Pharmaceutical CO LTD

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

Recalls official enforcement reports

🇦🇺

Mitomycin C 0.5mg (0.5mg/Ml, 0.05%) In Syringe (Terumo) For Ocular UseBatch: BK260330847Expiry: 15/0

Slade Health Pty Ltd · Apr 2026

Class IIdetails ↗

🇦🇺

MITOMYCIN C 2MG (0.4mg/mL, 0.04%) IN 0.9% SODIUM CHLORIDE IN SYRINGE (TERUMO) FOR OCULAR USEBatch: B

Slade Health Pty Ltd · Jan 2026

Class IIdetails ↗

🇺🇸

Mitomycin Injection Solution

Northern VA Compounders PLLC · Dec 2022

Class IIdetails ↗

🇺🇸

Mitomycin

Pharmacy Innovations · Dec 2022

Class IIdetails ↗

🇺🇸

Mitomycin

Pharmacy Innovations · Dec 2022

Class IIdetails ↗

🇺🇸

Mitomycin Injection

Pharmacy Plus, Inc. dba Vital Care Compounder · Oct 2022

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders17 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
MITOCIN mitomycin	20 mg	—	🇦🇺 AU	—	Active
OMEGAPHARM mitomycin powder for	2mg	—	🇦🇺 AU	Omegapharm	Active
MITOMYCIN 40 MG POWDER AND SOLVENT FOR INTRAVESICAL SOLUTION	40 MG	solution	🇬🇧 GB	MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH	Active
MITOMYCIN 2 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE	2 MG	injection	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
MITOMYCIN 10 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE	10 MG	injection	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
MITOMYCIN 20 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE	20 MG	injection	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
MITOMYCIN 40 MG, POWDER FOR SOLUTION FOR INJECTION/INFUSION	40 MG	injection	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Mitomycin	20mg/1	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Mitomycin	40mg/1	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Mitomycin	20mg/40mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Mitomycin	40mg/80mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
OMEGAPHARM mitomycin powder for	10mg	—	🇦🇺 AU	Omegapharm	Active
OMEGAPHARM mitomycin powder for	20mg	—	🇦🇺 AU	Omegapharm	Active
ACCORD mitomycin powder for	2mg	—	🇦🇺 AU	Omegapharm	Active
ACCORD mitomycin powder for	10mg	—	🇦🇺 AU	Omegapharm	Active

+2 more registrations on file

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.