Fondaparinux Sodium shortage — EU supply status & alternatives

Fondaparinux Sodium

—

🇦🇺 AUST R 80279 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🌐 EU🇺🇸 US🌐 CO🌐 IS

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$26.78DPMQ A$115.63details →

✓ 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)	Fondaparinux Sodium

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, Sandoz Inc., DR REDDY'S LABORATORIES LTD

Registrations on file	9

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$26.78

AEMP

Dispensed (DPMQ)

A$115.63

incl. fees

Pack

fondaparinux sodium 2.5 mg/0.5 mL injection, 2 x 0.5 mL syringes

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

11 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

Apitoria Pharma Private LTDDr Reddys Laboratories LTDJiangsu Hengrui Pharmaceuticals CO LTDFormosa Laboratories INCScinopharm Taiwan LTDHangzhou Zhongmei Huadong Pharmaceutical CO LTD+5 more

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

Shortage status by regulator official notices

🌐

EMA · 3d ago

High

🌐

INVIMA · just now

Medium

🇺🇸

United States

FDA · 1h ago

Medium

🌐

IMA · 1h ago

Resolved

🌐

NDI-TH · 1d ago

Resolved

Recalls official enforcement reports

🇺🇸

FONDAPARINUX SODIUM

AuroMedics Pharma LLC · Sept 2022

Class IIdetails ↗

🌐

Quixidar

Glaxo Group Ltd. · Mar 2008

Class Unifieddetails ↗

Verified timeline regulator events

🌐 25 June 2026

medium reported

🌐 1 June 2026

Shortage resolved

🇺🇸 29 Sept 2025

medium reported

🇺🇸 29 Sept 2025

medium reported

🌐 25 Sept 2025

medium reported

🌐 30 Jan 2025

Shortage resolved

Sources official regulators

🌐

INVIMA

verified just now

verify ↗

🇺🇸

FDA

verified 1h ago

verify ↗

🌐

IMA

verified 1h ago

verify ↗

🌐

NDI-TH

verified 1d ago

verify ↗

🌐

EMA

verified 3d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
ARIXTRA fondaparinux sodium	2.5mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ARIXTRA fondaparinux sodium	7.5mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ARIXTRA fondaparinux sodium	10.0mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ARIXTRA fondaparinux sodium	5.0mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Fondaparinux Sodium	2.5mg/.5mL	injection	🇺🇸 US	Sandoz Inc.	Active
Fondaparinux Sodium	5mg/.4mL	injection	🇺🇸 US	Sandoz Inc.	Active
Fondaparinux Sodium	7.5mg/.6mL	injection	🇺🇸 US	Sandoz Inc.	Active
Fondaparinux Sodium	10mg/.8mL	injection	🇺🇸 US	Sandoz Inc.	Active
FONDAPARINUX SODIUM INJECTION	—	solution	🇨🇦 CA	DR REDDY'S LABORATORIES 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.