Finasteride shortage — US supply status & alternatives

Finasteride

ATC D11AX10

🇦🇺 AUST R 330151 · Accord Healthcare Pty Ltd

Anticipated · Australia

Finapen

Anticipated · 🇦🇺 Australia & also short in🇺🇸 US🇨🇦 CA🇮🇹 IT🇧🇪 BE🇬🇷 GR🌐 MY🇳🇱 NL

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$56.24DPMQ A$166.48details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Tacrolimus-Monohydrate

Product attributes reference data we hold

Active ingredient (INN)	Finasteride
Brand names	Finapen
ATC level 5	D11AX10
ATC level 4	D11AX
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Accord Healthcare Pty Ltd, Generic Health Pty Ltd, SANDOZ LIMITED, Generics (UK) Limited +5 more
Registrations on file	13
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$56.24

AEMP

Dispensed (DPMQ)

A$166.48

incl. fees

Pack

finasteride 5 mg tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.98

Drug Tariff

🇺🇸 US

US$5.70

Acquisition

🇫🇷 FR

€12.92

Retail price

🇮🇹 IT

€7.88

Retail price

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

8 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 LTDCipla LTDDr Reddys Laboratories LTDSterling SPAHetero Labs LTDMsn Laboratories Private LTD+2 more

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

Shortage status by regulator official notices

🇺🇸

United States

FDA-FE · 10d ago

High

🇦🇺

Australia

TGA · 2h ago

High

🇨🇦

Canada

HC · 2h ago

Medium

🌐

NPRA · 3h ago

Medium

🇬🇷

EOF · 3h ago

Medium

🇧🇪

FAMHP · 4h ago

Medium

🇳🇱

Netherlands

CBG-MEB · 7h ago

Medium

🇮🇹

Italy

AIFA · 8h ago

Medium

Recalls official enforcement reports

🇺🇸

Finasteride

Direct Rx · Mar 2023

Class IIdetails ↗

🇺🇸

FINASTERIDE

Accord Healthcare, Inc. · Feb 2023

Class IIdetails ↗

🇺🇸

FINASTERIDE

Accord Healthcare, Inc. · Feb 2023

Class IIdetails ↗

🇺🇸

FINASTERIDE

Hetero Drugs Ltd. - Unit 1 · Dec 2016

Class IIIdetails ↗

Verified timeline regulator events

🇦🇺 4 Sept 2026

Shortage resolved

🇦🇺 28 Aug 2026

low reported

🇮🇹 1 Aug 2026

medium reported

🇳🇱 30 June 2026

medium reported

🇧🇪 18 June 2026

medium reported

🇳🇱 9 June 2026

medium reported

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇺🇸

FDA

verified 2h ago

verify ↗

🇦🇺

TGA

verified 2h ago

verify ↗

🌐

NPRA

verified 3h ago

verify ↗

🇬🇷

EOF

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 4h ago

verify ↗

🇳🇱

CBG-MEB

verified 7h ago

verify ↗

🇮🇹

AIFA

verified 8h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders13 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
Finasteride Viatris	1 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Finasteride Gh 1	1 mg	—	🇦🇺 AU	Generic Health Pty Ltd	Active
Aurobindo	5 mg	tabfc	🇦🇺 AU	—	Active
FINASTERIDE 5MG FILM-COATED TABLETS	5MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
FINASTERIDE 1 MG TABLETS	1 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
FINASTERIDE 5MG FILM COATED TABLETS	5MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
FINASTERIDE 1MG FILM-COATED TABLETS	1MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
FINASTERIDE 5MG TABLETS	5MG	tablet	🇬🇧 GB	DR REDDY'S LABORATORIES (UK) LIMITED	Active
FINASTERIDE 1 MG FILM-COATED TABLETS	1 MG	tablet	🇬🇧 GB	STRANDHAVEN LIMITED	Active
FINASTERIDE 5 MG FILM-COATED TABLETS	5 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
FINASTERIDE 5 MG TABLETS	5 MG	tablet	🇬🇧 GB	RELONCHEM LIMITED	Active
FINASTERIDE 1MG TABLETS	1MG	tablet	🇬🇧 GB	RELONCHEM LIMITED	Active
Finasteride Ascend	5 MG	tablet	🇬🇧 GB	ASCEND LABORATORIES (UK) LIMITED	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.