Prednisolone shortage — US supply status & alternatives

Prednisolone

ATC H02AB06 · Synthetic glucocorticoid

🇦🇺 AUST R 376591 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

WHO Essential Medicine

OmnipredPred Forte DeltacortrilPanafcortelone

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇩🇪 DE🇮🇪 IE🇳🇱 NL

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$2.88DPMQ A$20.60details →

Product attributes reference data we hold

Active ingredient (INN)	Prednisolone
Brand names	Omnipred, Pred Forte, Deltacortril, Panafcortelone
ATC level 5	H02AB06
ATC level 4	H02AB
Drug class	Synthetic glucocorticoid
Therapeutic category	Corticosteroid
Strength	1mg · 5mg · 25mg · 1mg/ml oral
Dosage form	tablet · oral solution · eye drops
Route of administration	oral · ophthalmic
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, Sun Pharma ANZ Pty Ltd, LEO Pharma Pty Ltd, Pfizer Limited +5 more
Registrations on file	27
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$2.88

AEMP

Dispensed (DPMQ)

A$20.60

incl. fees

Pack

prednisolone 1 mg tablet, 100

tablet

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.54

Acquisition

🇬🇧 GB

£0.65

Drug Tariff

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

9 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

Farmabios SPAEuroapi FranceZhejiang Xianju Pharmaceutical CO LTDTianjin Tianyao Pharmaceuticals CO LTDCuria Spain SauSymbiotec Pharmalab Private LTD+3 more

Manufacturing countries: Italy, France, China, Spain, India · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 2h ago

High

🇨🇦

Canada

HC · 3h ago

High

🇩🇪

Germany

BfArM · 10d ago

Medium

🇮🇪

Ireland

HPRA · 1mo ago

Medium

🇳🇱

Netherlands

CBG-MEB · 1mo ago

Medium

🇫🇷

France

ANSM · 1mo ago

Resolved

🇳🇴

Norway

NOMA · 1mo ago

Resolved

Recalls official enforcement reports

🇺🇸

PRED MILD

AbbVie Inc. · May 2026

Class IIIdetails ↗

🇺🇸

Prednisolone Oral Solution

Akorn, Inc. · Apr 2023

Class IIdetails ↗

🇺🇸

PREDNISOLONE ACETATE

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

🇺🇸

Prednisolone

RXQ Compounding LLC · June 2019

Class IIdetails ↗

🇺🇸

Prednisolone And Gatifloxacin And Ketorolac Ophthalmic Solut

Promise Pharmacy, LLC · Dec 2018

Class IIdetails ↗

🇺🇸

Prednisolone And Gatifloxacin And Bromfenac Ophthalmic Solut

Promise Pharmacy, LLC · Dec 2018

Class IIdetails ↗

Sources official regulators

🇺🇸

FDA MedWatch

verified 2h ago

verify ↗

🇨🇦

verified 3h ago

verify ↗

🇩🇪

BfArM

verified 10d ago

verify ↗

🇮🇪

HPRA

verified 1mo ago

verify ↗

🇳🇱

CBG-MEB

verified 1mo ago

verify ↗

🇫🇷

ANSM

verified 1mo ago

verify ↗

🇳🇴

NOMA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
Aspen Prednisolone	25mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
YONSA MPRED abiraterone acetate	125 mg	—	🇦🇺 AU	Sun Pharma ANZ Pty Ltd	Active
TANILONE methylprednisolone aceponate	1 mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
SUPRIAD CREAM methylprednisolone aceponate	1mg	—	🇦🇺 AU	LEO Pharma Pty Ltd	Active
SUPRIAD OINTMENT Methylprednisolone Aceponate	1mg	—	🇦🇺 AU	LEO Pharma Pty Ltd	Active
SUPRIAD FATTY OINTMENT Methylprednisolone Aceponate	1mg	—	🇦🇺 AU	LEO Pharma Pty Ltd	Active
SUPRIAD LOTION methylprednisolone aceponate 0.1% lotion tube	0.1%	—	🇦🇺 AU	LEO Pharma Pty Ltd	Active
Methylprednisolone	40 MG	injection	🇬🇧 GB	Pfizer Limited	Active
Methylprednisolone	125 MG	injection	🇬🇧 GB	Pfizer Limited	Active
Methylprednisolone	500 MG	injection	🇬🇧 GB	Pfizer Limited	Active
Methylprednisolone	1 G	injection	🇬🇧 GB	Pfizer Limited	Active
PREDNISOLONE 2.5MG GASTRO-RESISTANT TABLETS	2.5MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
PREDNISOLONE 5MG GASTRO-RESISTANT TABLETS	5MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
PREDNISOLONE 1 MG TABLETS	1 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
PREDNISOLONE 5 MG TABLETS	5 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active

+12 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.