Irinotecan Hydrochloride shortage — NZ supply status & alternatives

Irinotecan Hydrochloride

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🇦🇺 AUST R 171227 · Fresenius Kabi Australia Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇳🇿 NZ

In supply in Australia

Reading today’s signals…

✓ 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 reference data we hold

Active ingredient (INN)	Irinotecan Hydrochloride
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Fresenius Kabi Australia Pty Ltd, Hospira UK Limited, MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, Wockhardt Bio Pty Ltd +6 more

Registrations on file	24

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

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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

14 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

Scinopharm Taiwan LTDPliva-Lachema AsFermion OyJiangsu Hengrui Pharmaceuticals CO LTDOlon SPALaurus Labs LTD+8 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

May 2023

Latest approval

Shortage status by regulator official notices

🇳🇿

New Zealand

Pharmac · 1d ago

High

🇺🇸

United States

FDA · 1h ago

Medium

Recalls official enforcement reports

🇺🇸

IRINOTECAN HYDROCHLORIDE

Hikma Pharmaceuticals USA Inc. · June 2020

Class IIdetails ↗

🇺🇸

IRINOTECAN HYDROCHLORIDE

Hikma Pharmaceuticals USA Inc. · June 2020

Class IIdetails ↗

🇺🇸

IRINOTECAN HYDROCHLORIDE

Ingenus Pharmaceuticals Llc · June 2018

Class IIdetails ↗

🇺🇸

IRINOTECAN HYDROCHLORIDE

Ingenus Pharmaceuticals Llc · June 2018

Class IIdetails ↗

🇺🇸

IRINOTECAN HYDROCHLORIDE

West-Ward Pharmaceutical Corp. · Sept 2013

Class IIdetails ↗

🇺🇸

IRINOTECAN HYDROCHLORIDE

West-Ward Pharmaceutical Corp. · Sept 2013

Class IIdetails ↗

Verified timeline regulator events

🇳🇿 19 June 2026

high reported

🇳🇿 22 Apr 2026

high reported

🇺🇸 24 Feb 2026

medium reported

🇺🇸 26 Sept 2025

medium reported

🇺🇸 4 Aug 2025

medium reported

Sources official regulators

🇺🇸

FDA

verified 1h ago

verify ↗

🇳🇿

Pharmac

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders24 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
IRINOTECAN KABI irinotecan hydrochloride trihydrate	100 mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
IRINOTECAN KABI irinotecan hydrochloride trihydrate	40 mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
IRINOTECAN HYDROCHLORIDE 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	20MG	solution	🇬🇧 GB	Hospira UK Limited	Active
Irinotecan Hydrochloride Medac	20 MG	solution	🇬🇧 GB	MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH	Active
IRINOTECAN WKT irinotecan hydrochloride	300mg	—	🇦🇺 AU	Wockhardt Bio Pty Ltd	Active
IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION	20 MG	solution	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Irinotecan Hydrochloride	20mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
CAMPTOSAR irinotecan hydrochloride trihydrate	100mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
CAMPTOSAR irinotecan hydrochloride trihydrate	40mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
OMEGAPHARM IRINOTECAN irinotecan hydrochloride trihydrate	100 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
OMEGAPHARM IRINOTECAN irinotecan hydrochloride trihydrate	40 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
CAMPTOSAR irinotecan hydrochloride trihydrate	300mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
MEDITAB IRINOTECAN irinotecan hydrochloride trihydrate	100 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
MEDITAB IRINOTECAN irinotecan hydrochloride trihydrate	40 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
IRINOTECAN KABI irinotecan hydrochloride trihydrate	300mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active

+9 more registrations on file

Mederti Drug Report

Generated 3 July 2026 · Australia market · 2 regulatory sources

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.