Ertapenem shortage — IT supply status & alternatives

Ertapenem

ATC J01DH03

🇦🇺 AUST R 81449 · Merck Sharp & Dohme Australia Pty Ltd

In supply · Australia

Ertapenem Cipla

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇳🇴 NO

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)	Ertapenem
Brand names	Ertapenem Cipla
ATC level 5	J01DH03

Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Controlled substance	No

Marketing-authorisation holders	Hikma Pharmaceuticals USA, Inc., HIKMA PHARMACEUTICALS USA INC., Merck Sharp & Dohme Australia Pty Ltd, Fresenius Kabi Australia Pty Ltd +5 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

—

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$30.16

Acquisition

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

7 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

Solara Active Pharma Sciences LTDAcs Dobfar SPAApitoria Pharma Private LTDShandong Anhong Pharmaceutical CO LTDGland Pharma LTDJilin Asymchem Pharmaceuticals CO LTD+1 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
ertapenem sodium	1g/1	injection	🇺🇸 US	Hikma Pharmaceuticals USA, Inc.	Active
Ertapenem	1g/1	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
INVANZ ertapenem	1g	—	🇦🇺 AU	Merck Sharp & Dohme Australia Pty Ltd	Active
Kabi	1 g	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
Juno	1 g	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Ertapenem	1g/20mL	injection	🇺🇸 US	Savior Lifetec Corporation	Active
Ertapenem SUN	—	—	🌐 EU	SUN Pharmaceutical Industries (Europe) B.V.	Active
Ertapenem Hospira	—	—	🌐 EU	Hospira UK Limited	Application withdrawn
Ertapenem For	—	solution	🇨🇦 CA	JUNO PHARMACEUTICALS CORP.	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.