Enalapril Maleate shortage — US supply status & alternatives

Enalapril Maleate

ATC C09AA02

🇦🇺 AUST R 126490 · Sandoz Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US

In supply in Australia

Reading today’s signals…

✓ 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)	Enalapril Maleate
ATC level 5	C09AA02
ATC level 4	C09AA
Therapeutic category	Auto-created by FDA Drug Enforcement — Foreign Manufacturer Recalls scraper

Controlled substance	No

Marketing-authorisation holders	Sandoz Pty Ltd, ROSEMONT PHARMACEUTICALS LIMITED, SANDOZ LIMITED, Generics (UK) Limited +5 more

Registrations on file	19

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

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.

Other markets

🇺🇸 US

US$0.06

Acquisition

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

5 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

Farmhispania SADr Reddys Laboratories LTDZhejiang Huahai Pharmaceutical CO LTDNeuland Laboratories LTDSri Krishna Pharmaceuticals LTD

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

Recalls official enforcement reports

🇺🇸

ENALAPRIL MALEATE

JB Chemicals and Pharmaceuticals Ltd · Apr 2026

Class IIdetails ↗

🇺🇸

ENALAPRIL MALEATE

Golden State Medical Supply Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

ENALAPRIL MALEATE

Golden State Medical Supply Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

ENALAPRIL MALEATE

Golden State Medical Supply Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

ENALAPRIL MALEATE

Golden State Medical Supply Inc. · Mar 2022

Class IIdetails ↗

🇺🇸

Enalapril Maleate

Aidarex Pharmaceuticals LLC · June 2018

Class IIIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
Enalapril/Hct Sandoz	20mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
ENALAPRIL MALEATE 5MG/5ML ORAL SOLUTION	5MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Enalapril Maleate/Hydrochlorothiazide 20/	12.5MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
Enalapril Maleate And Hydrochlorothiazide	20 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
ENALAPRIL MALEATE TABLETS 2.5MG	2.5MG	tablet	🇬🇧 GB	DEXCEL PHARMA LIMITED	Active
ENALAPRIL MALEATE TABLETS 5MG	5MG	tablet	🇬🇧 GB	DEXCEL PHARMA LIMITED	Active
ENALAPRIL MALEATE TABLETS 10MG	10MG	tablet	🇬🇧 GB	DEXCEL PHARMA LIMITED	Active
ENALAPRIL MALEATE TABLETS 20MG	20MG	tablet	🇬🇧 GB	DEXCEL PHARMA LIMITED	Active
ENALAPRIL MALEATE 2.5MG TABLETS	2.5MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
ENALAPRIL MALEATE 5MG TABLETS	5MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
ENALAPRIL MALEATE 10MG TABLETS	10MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
ENALAPRIL MALEATE 20MG TABLETS	20MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
ENALAPRIL MALEATE 10 MG TABLETS	10 MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
ENALAPRIL MALEATE 20 MG TABLETS	20 MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
Enalapril Maleate/Hydrochlorothiazide	20MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active

+4 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.