Hydralazine Hydrochloride shortage — CA supply status & alternatives

Hydralazine Hydrochloride

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🇦🇺 AUST R 17575 · Alphapharm Pty Ltd

In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Yes — approved substitute available

TGA s19A · hydrapres-hydralazine-hydrochloride-20mg-powder-injectable-solution-ampoules-spain

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Hydralazine Hydrochloride

Therapeutic category	Auto-created by Pharmac — New Zealand Medicine Supply Disruptions scraper

Controlled substance	No

Marketing-authorisation holders	Alphapharm Pty Ltd, Amdipharm Mercury Australia Pty Ltd, Link Medical Products Pty Ltd T/A Link Pharmaceuticals, Henry Schein, Inc. +2 more

Registrations on file	9

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

✓

Section 19A approval in force · hydrapres-hydralazine-hydrochloride-20mg-powder-injectable-solution-ampoules-spain

TGA Section 19A: overseas-registered 'HYDRAPRES hydralazine hydrochloride 20mg powder for injectable solution ampoules (Spain)' approved for import and supply in Australia during a shortage. Origin: Spain. Expires Aug 2026. Verify on TGA Section 19A approvals ↗

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

13 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

Navinta LLCApitoria Pharma Private LTDCohance Lifesciences LTDSumitomo Chemical CO LTDHetero Labs LTDArchimica SPA+7 more

Manufacturing countries: United States, India, Japan, Italy · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Hydralazine Hydrochloride

SKY PACKAGING · Jan 2025

Class IIdetails ↗

🇺🇸

Hydralazine Hydrochloride

SKY PACKAGING · Jan 2025

Class IIdetails ↗

🇺🇸

HYDRALAZINE HYDROCHLORIDE

CARDINAL HEALTHCARE · Jan 2022

Class IIdetails ↗

🇺🇸

HYDRALAZINE HYDROCHLORIDE

Mckesson Medical Surgical · Mar 2017

Class IIdetails ↗

🇺🇸

HYDRALAZINE HYDROCHLORIDE

Fresenius Kabi USA, LLC · July 2015

Class IIIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
Alphapress	25mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
APRESOLINE hydralazine hydrochloride	20mg	—	🇦🇺 AU	Amdipharm Mercury Australia Pty Ltd	Active
Alphapress	50mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
HYDRALAZINE LINK hydralazine hydrochloride	20 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Hydralazine Hydrochloride	20mg/mL	injection	🇺🇸 US	Henry Schein, Inc.	Active
Hydralazine Hydrochloride	100mg/1	tablet	🇺🇸 US	NCS HealthCare of KY, LLC dba Vangard Labs	Active
Hydralazine Hydrochloride	10mg/1	tablet	🇺🇸 US	MAJOR PHARMACEUTICALS	Active
Hydralazine Hydrochloride	25mg/1	tablet	🇺🇸 US	MAJOR PHARMACEUTICALS	Active
Hydralazine Hydrochloride	50mg/1	tablet	🇺🇸 US	MAJOR PHARMACEUTICALS	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.