Cyclophosphamide shortage — CA supply status & alternatives

Cyclophosphamide

ATC L01AA01

🇦🇺 AUST R 82127 · Baxter Healthcare Pty Ltd

In supply · Australia

EndoxanCyclophosphamid HEXALCiclofosfamide SeacrossENDOXAN cyclophosphamide

In supply · 🇦🇺 Australia · short in🇨🇦 CA🌐 EU🇺🇸 US🇫🇷 FR🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$12.15details →

✓ Can I substitute?

Yes — under S19A

TGA s19A · cyclophosphamide-injection-usp-1-gram-powder-injection-vial-northstar-rx-usa

Product attributes reference data we hold

Active ingredient (INN)	Cyclophosphamide
Brand names	Endoxan, Cyclophosphamid HEXAL, Ciclofosfamide Seacross, ENDOXAN cyclophosphamide
ATC level 5	L01AA01
ATC level 4	L01AA
Therapeutic category	Auto-created by Agence nationale de sécurité du médicament — Disponibilité scraper
Controlled substance	No
Marketing-authorisation holders	Baxter Healthcare Pty Ltd, Accord Healthcare Pty Ltd, BAXTER HEALTHCARE LIMITED, ACCORD-UK LIMITED +7 more
Registrations on file	29
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$12.15

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

cyclophosphamide 500 mg injection, 1 vial

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$1.63

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · cyclophosphamide-injection-usp-1-gram-powder-injection-vial-northstar-rx-usa

TGA Section 19A: overseas-registered 'Cyclophosphamide for injection, USP 1 gram powder for injection vial (NorthStar Rx, USA)' approved for import and supply in Australia during a shortage. Origin: NorthStar Rx, USA. Expires Nov 2026. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-injection-usp-2-grams-vial-sagent-usa

TGA Section 19A: overseas-registered 'Cyclophosphamide for injection, USP 2 grams per vial (Sagent, USA)' approved for import and supply in Australia during a shortage. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-injection-usp-2-grams-powder-injection-vial-northstar-rx-usa

TGA Section 19A: overseas-registered 'Cyclophosphamide for injection, USP 2 grams powder for injection vial (NorthStar Rx, USA)' approved for import and supply in Australia during a shortage. Origin: NorthStar Rx, USA. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-seacross-1000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk-1

TGA Section 19A: overseas-registered 'Cyclophosphamide Seacross 1000mg powder for solution for injection/infusion vial (Seacross Pharmaceuticals, UK)' approved for import and supply in Australia during a shortage. Origin: Seacross Pharmaceuticals, UK. Expires Aug 2026. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-seacross-2000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk-0

TGA Section 19A: overseas-registered 'Cyclophosphamide Seacross 2000mg powder for solution for injection/infusion vial (Seacross Pharmaceuticals, UK)' approved for import and supply in Australia during a shortage. Origin: Seacross Pharmaceuticals, UK. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-seacross-1000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk-0

TGA Section 19A: overseas-registered 'Cyclophosphamide Seacross 1000mg powder for solution for injection/infusion vial (Seacross Pharmaceuticals, UK)' approved for import and supply in Australia during a shortage. Expires Nov 2026. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-seacross-2000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk-1

✓

Section 19A approval in force · cyclophosphamide-seacross-2000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk

TGA Section 19A: overseas-registered 'Cyclophosphamide Seacross 2000mg powder for solution for injection/infusion vial (Seacross Pharmaceuticals, UK)' approved for import and supply in Australia during a shortage. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · cyclophosphamide-seacross-1000mg-powder-solution-injectioninfusion-vial-seacross-pharmaceuticals-uk

TGA Section 19A: overseas-registered 'Cyclophosphamide Seacross 1000mg powder for solution for injection/infusion vial (Seacross Pharmaceuticals, UK)' approved for import and supply in Australia during a shortage. Expires Nov 2026. Verify on TGA Section 19A approvals ↗

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

Ampac Fine Chemicals LLCZhejiang Hisun Pharmaceutical CO LTDBaxter Oncology GMBHBaxter Healthcare CorpJiangsu Hengrui Pharmaceuticals CO LTDHetero Labs LTD+8 more

Manufacturing countries: United States, China, Canada, India, Taiwan · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

CYCLOPHOSPHAMIDE

Sandoz Inc · Sept 2025

Class IIdetails ↗

🇺🇸

Cyclophosphamide

Infusion Options, Inc. · June 2019

Class IIdetails ↗

🇺🇸

Cyclophosphamide

Kroger Specialty Pharmacy, Inc. · Apr 2018

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders29 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
ENDOXAN cyclophosphamide	500mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
ENDOXAN cyclophosphamide	2g	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
ENDOXAN cyclophosphamide	1g	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
Intas	1000 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Accord	2000 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Intas	2000 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Accord	1000 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Intas	500 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Accord	500 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Reach	500 mg	—	🇦🇺 AU	—	Active
Reach	1000 mg	—	🇦🇺 AU	—	Active
CYCLOPHOSPHAMIDE INJECTION 500MG	500MG	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
CYCLOPHOSPHAMIDE INJECTION 1G	1G	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
CYCLOPHOSPHAMIDE TABLETS 50 MG	50 MG	tablet	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
CYCLOPHOSPHAMIDE 200 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION	200 MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active

+14 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.