Polymyxin B Sulfate shortage — CA supply status & alternatives

Polymyxin B Sulfate

—

In supply · Australia

Odan-Spor

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

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

Brand names
Active ingredient (INN)	Polymyxin B Sulfate

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	Henry Schein, Bausch & Lomb Incorporated, Bausch & Lomb Incoporated, XGen Pharmaceuticals DJB, Inc. +2 more

Registrations on file	14

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.

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

12 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

Xellia Pharmaceuticals ApsHangzhou Zhongmei Huadong Pharmaceutical CO LTDBiotika AsAlp Pharm Beijing CO LTDYancheng Youhua Pharmaceutical And Chemical Technology CO LTDShandong Luxi Pharmaceutical CO LTD+6 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

July 2025

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 3h ago

High

🇺🇸

United States

ANSM Ruptures · 3mo ago

High

Verified timeline regulator events

🇺🇸 26 Jan 2022

high reported

🇨🇦 17 Jan 2017

high reported

🇨🇦 15 Apr 2016

high reported

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇺🇸

ANSM Ruptures

verified 3mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders14 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate	400; 5; 5000[iU]/g; mg/g; [iU]/g	ointment	🇺🇸 US	Henry Schein	Active
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate	400; 5; 50000[iU]/g; mg/g; [iU]/g	ointment	🇺🇸 US	Henry Schein	Active
Polymyxin B Sulfate and Trimethoprim	10000; 1[USP'U]/mL; mg/mL	solution	🇺🇸 US	Bausch & Lomb Incorporated	Active
Bacitracin Zinc and Polymyxin B Sulfate	500; 10000[USP'U]/g; [USP'U]/g	ointment	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin and Polymyxin B Sulfates and Hydrocortisone	10; 3.5; 10000mg/mL; mg/mL; [USP'U]/mL	solution	🇺🇸 US	Bausch & Lomb Incoporated	Active
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc	400; 3.5; 10000[USP'U]/g; mg/g; [USP'U]/g	ointment	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone	400; 10; 3.5; 10000[USP'U]/g; mg/g; mg/g; [USP'U]/g	ointment	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin And Polymyxin B Sulfates And Gramicidin	.025; 1.75; 10000mg/mL; mg/mL; [USP'U]/mL	solution	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin and Polymyxin B Sulfates and Dexamethasone	1; 3.5; 10000mg/g; mg/g; [USP'U]/g	ointment	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin Polymyxin B Sulfates and Dexamethasone	1; 3.5; 10000mg/mL; mg/mL; [USP'U]/mL	suspension	🇺🇸 US	Bausch & Lomb Incorporated	Active
Neomycin and Polymyxin B Sulfates	40; 200000mg/mL; [USP'U]/mL	solution	🇺🇸 US	XGen Pharmaceuticals DJB, Inc.	Active
Neomycin and Polymyxin B Sulfates and Dexamethasone	1; 3.5; 10000mg/g; mg/g; [iU]/g	ointment	🇺🇸 US	A-S Medication Solutions	Active
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic	10; 3.5; 10000mg/mL; mg/mL; [USP'U]/mL	suspension	🇺🇸 US	A-S Medication Solutions	Active
Neomycin and Polymyxin B Sulfates and Dexamethasone	1; 3.5; 10000mg/mL; mg/mL; [USP'U]/mL	suspension	🇺🇸 US	Sandoz Inc.	Active

Mederti Drug Report

Generated 4 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.