Amphotericin B shortage — DE supply status & alternatives

Amphotericin B

ATC A01AB04

🇦🇺 AUST R 380962 · Sun Pharma ANZ Pty Ltd

In supply · Australia

Abelcet Complejo LipidicoAMPHOTERICIN LIPOSOMAL SUN amphotericin B

In supply · 🇦🇺 Australia · short in🇩🇪 DE🇺🇸 US

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.96DPMQ A$18.56details →

✓ 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)	Amphotericin B
Brand names	Abelcet Complejo Lipidico, AMPHOTERICIN LIPOSOMAL SUN amphotericin B
ATC level 5	A01AB04
ATC level 4	A01AB
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Sun Pharma ANZ Pty Ltd, TILLOMED LABORATORIES LIMITED, Gilead Sciences International Limited, SUN PHARMACEUTICAL INDUSTRIES EUROPE BV +8 more
Registrations on file	14
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$3.96

AEMP

Dispensed (DPMQ)

A$18.56

incl. fees

Pack

amphotericin B 10 mg lozenge, 20

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

4 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.

Moderate concentration risk

Xellia Pharmaceuticals ApsNorth China Pharmaceutical Huasheng CO LTDAsence Pharma Private LTDZhejiang Tiantai Pharmaceutical CO LTD

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

Recalls official enforcement reports

🇺🇸

AMPHOTERICIN B

SUN PHARMACEUTICAL INDUSTRIES INC · Apr 2024

Class IIdetails ↗

🇺🇸

Amphotericin B

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy · Apr 2019

Class IIdetails ↗

🇺🇸

AMBISOME

Gilead Sciences, Inc. · June 2013

Class IIdetails ↗

🇺🇸

AMBISOME

Astellas Pharma US Inc · June 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders14 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
AMPHOTERICIN LIPOSOMAL RAN amphotericin B	50mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
AMPHOTERICIN LIPOSOMAL SUN amphotericin B	50mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
AMPHOTERICIN LIPOSOMAL RBX amphotericin B	50mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
Amphotericin B Tillomed Liposomal	50 MG	powder	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Amphotericin B Gilead Liposomal	50 MG	powder	🇬🇧 GB	Gilead Sciences International Limited	Active
Amphotericin B Sun Pharma Liposomal	50 MG	powder	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
FUNGILIN amphotericin B	10 mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
AMBISOME amphotericin B B	50mg	—	🇦🇺 AU	Gilead Sciences Pty Ltd	Active
Amphotericin B	50mg/1	injectable,	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
Amphotericin B	50mg/10mL	injection	🇺🇸 US	XGen Pharmaceuticals DJB, Inc.	Active
Amphotericin B	50mg/12.5mL	injection	🇺🇸 US	Eugia US LLC	Active
Amphotericin B liposome	50mg/12.5mL	injection	🇺🇸 US	Mylan Institutional LLC	Active
Amphotericin B For Injection, Usp	—	solution	🇨🇦 CA	STERIMAX INC	Active
Taro-Amphotericin B Liposomal	—	solution	🇨🇦 CA	TARO PHARMACEUTICALS INC	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.