Tamsulosin Hydrochloride shortage — BE supply status & alternatives

Tamsulosin Hydrochloride

—

🇦🇺 AUST R 336015 · Sandoz Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇮🇹 IT🇺🇸 US🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$48.14DPMQ A$114.80details →

✓ 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)	Tamsulosin Hydrochloride
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Sandoz Pty Ltd, Southern Cross Pharma Pty Ltd, TEVA UK LIMITED, SUN PHARMA UK LIMITED +13 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$48.14

AEMP

Dispensed (DPMQ)

A$114.80

incl. fees

Pack

tamsulosin hydrochloride 400 microgram modified release tablet, 30

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

17 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

Wockhardt LTDVasudha Pharma Chem LTDSun Pharmaceutical Industries LTDLek Pharmaceuticals DdZydus Lifesciences LTDScinopharm Taiwan LTD+11 more

Manufacturing countries: India, Taiwan, Spain · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

May 2022

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 3h ago

Medium

🇺🇸

United States

FDA · 3h ago

Medium

🇧🇪

FAMHP · 8h ago

Medium

🇮🇹

Italy

AIFA · 1d ago

Medium

Recalls official enforcement reports

🇺🇸

TAMSULOSIN HYDROCHLORIDE

Macleods Pharma Usa Inc · July 2019

Class IIdetails ↗

🇺🇸

TAMSULOSIN HYDROCHLORIDE

Ascend Laboratories LLC · Feb 2019

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 22 June 2026

medium reported

🇧🇪 19 June 2026

medium reported

🇨🇦 10 June 2026

medium reported

🇧🇪 6 May 2026

medium reported

🇧🇪 3 Apr 2026

medium reported

🇨🇦 25 Mar 2026

medium reported

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇺🇸

FDA

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 8h ago

verify ↗

🇮🇹

AIFA

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 17 MA holders

Product	Strength	Form	Market	MA holder	Status
FLOSIX tamsulosin hydrochloride	400 microgram	—	🇦🇺 AU	Sandoz Pty Ltd	Active
TAMSULOSIN LUPIN SR tamsulosin hydrochloride	400 microgram	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
BTC TAMSULOSIN SR tamsulosin hydrochloride	400 microgram	—	🇦🇺 AU	Sandoz Pty Ltd	Active
Dutasteride/Tamsulosin Sandoz	500 microgram	—	🇦🇺 AU	Sandoz Pty Ltd	Active
TAMSULOSIN-WGR SR tamsulosin hydrochloride	400 microgram	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS MR CAPSULES	400 MICROGRAM	capsule	🇬🇧 GB	TEVA UK LIMITED	Active
Tamsulosin Hydrochloride Sun Pharma	400 MICROGRAM	capsule	🇬🇧 GB	SUN PHARMA UK LIMITED	Active
Tamsulosin Hydrochloride Somex Pharma	400 MICROGRAM	capsule	🇬🇧 GB	STRANDHAVEN LIMITED	Active
Dutasteride / Tamsulosin Hydrochloride	0.5MG	capsule	🇬🇧 GB	MILPHARM LIMITED	Active
Solifenacin Succinate/Tamsulosin Hydrochloride Milpharm	6MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Tamsulosin Hydrochloride Zentiva	400 MICROGRAM	capsule	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
Solifenacin Succinate/Tamsulosin Hydrochloride Zentiva	6 MG	tablet	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
Dutasteride/Tamsulosin Hydrochloride	0.5MG	capsule	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Tamsulosin Hydrochloride Liconsa	0.4 MG	capsule	🇬🇧 GB	LABORATORIOS LICONSA SA	Active
Tamsulosin Hydrochloride Consilient Health	400 MICROGRAM	capsule	🇬🇧 GB	CONSILIENT HEALTH LIMITED	Active

+12 more registrations on file

Mederti Drug Report

Generated 2 July 2026 · Australia market · 4 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.