Heparin Sodium shortage — US supply status & alternatives

Heparin Sodium

ATC B01AB01

🇦🇺 AUST R 394930 · Interpharma Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇬🇷 GR

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Heparin Sodium
ATC level 5	B01AB01
ATC level 4	B01AB

Controlled substance	No

Marketing-authorisation holders	Interpharma Pty Ltd, BAXTER HEALTHCARE LIMITED, LABORATORIOS FARMACEUTICOS ROVI S.A., WOCKHARDT UK LIMITED +7 more

Registrations on file	26

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.

Other markets

🇺🇸 US

US$1.16

Acquisition

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

21 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

Scientific Protein Laboratories LLCPfizer INCBiochem Sioux City INCSmithfield Bioscience INCBiochem Oss BVShenzhen Hepalink Pharmaceutical Group CO LTD+15 more

Manufacturing countries: United States, Netherlands, China, Spain, Austria, Italy, India · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

HEPARIN SODIUM IN SODIUM CHLORIDE

Baxter Healthcare Corporation · Aug 2024

Class Idetails ↗

🇺🇸

HEPARIN SODIUM

Sagent Pharmaceuticals Inc · Feb 2023

Class IIdetails ↗

🇺🇸

HEPARIN SODIUM

Pfizer Inc. · Dec 2022

Class IIdetails ↗

🇺🇸

Heparin Sodium

SCA Pharmaceuticals · July 2020

Class Idetails ↗

🇺🇸

Heparin Sodium

SCA Pharmaceuticals · July 2020

Class Idetails ↗

🇺🇸

Heparin Sodium

SCA Pharmaceuticals · July 2020

Class Idetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders26 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
Heparin INTERPHARMA heparin sodium	5000 IU	—	🇦🇺 AU	Interpharma Pty Ltd	Active
Heparin Sodium Bp	1000 IU	infusion	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Heparin Sodium Bp	2000 IU	infusion	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Heparin Sodium Bp	2500 IU	infusion	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Heparin Sodium Bp	5000 IU	infusion	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Heparin Sodium Rovi	000 IU	injection	🇬🇧 GB	LABORATORIOS FARMACEUTICOS ROVI S.A.	Active
HEPARIN SODIUM 1,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION	—	injection	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
HEPARIN SODIUM 25,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION	—	injection	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
HEPARIN SODIUM 5,000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION	—	injection	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
HEPARIN SODIUM 1000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION	—	injection	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES.	—	solution	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
Heparin Sodium 5	—	injection	🇬🇧 GB	PANPHARMA	Active
HEPARIN SODIUM 10 IU/ML I.V. FLUSH SOLUTION	10 IU	solution	🇬🇧 GB	KENT PHARMA UK LIMITED	Active
HEPARIN SODIUM 100 IU/ML. I.V FLUSH SOLUTION	100 IU	solution	🇬🇧 GB	KENT PHARMA UK LIMITED	Active
HEPARIN SODIUM 1000IU/ML AMPOULE SOLUTION FOR INFUSION	1000IU	solution	🇬🇧 GB	KENT PHARMA UK LIMITED	Active

+11 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.