Cefepime shortage — CA supply status & alternatives

Cefepime

ATC J01DE01

🇦🇺 AUST R 156639

In supply · Australia

In supply · 🇦🇺 Australia · short in🇨🇦 CA

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

Controlled substance
Active ingredient (INN)	Cefepime
ATC level 5	J01DE01
ATC level 4	J01DE
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Marketing-authorisation holders	HIKMA PHARMACEUTICALS USA INC., AFT Pharmaceuticals Pty Ltd, Fresenius Kabi Australia Pty Ltd, B. Braun Medical Inc. +3 more

Registrations on file	18

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

🇫🇷 FR

€12.84

Retail price

🇺🇸 US

US$3.73

Acquisition

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

6 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

Orchid Pharma LTDAntibioticos Do Brasil LtdaAcs Dobfar SPAQilu Antibiotics Pharmaceutical CO LTDNectar Lifesciences LTDFresenius Kabi Ipsum Srl

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

Recalls official enforcement reports

🇺🇸

Cefepime

Sentara Infusion Services · Dec 2022

Class IIdetails ↗

🇺🇸

Cefepime

Walgreens Infusion Services · Nov 2015

Class IIdetails ↗

🇺🇸

Cefepime

Sentara Enterprises · Sept 2015

Class IIdetails ↗

🇺🇸

Cefepime

Lincare, Inc. · May 2015

Class IIdetails ↗

🇺🇸

Cefepime

Franck's Lab Inc dba Trinity Care Solutions · May 2014

Class IIdetails ↗

🇺🇸

Cefepime

Franck's Lab Inc dba Trinity Care Solutions · May 2014

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Cefepime Hydrochloride	1g/1	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Cefepime Hydrochloride	2g/1	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Auro-Cefepime	2 g	—	🇦🇺 AU	—	Active
Auro-Cefepime	1 g	—	🇦🇺 AU	—	Active
Bindozef	1g	—	🇦🇺 AU	—	Active
Bindozef	2g	—	🇦🇺 AU	—	Active
AFT cefepime hydrochloride monohydrate equivalent to	1 g	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
AFT cefepime hydrochloride monohydrate equivalent to	2 g	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
AFT cefepime hydrochloride monohydrate equivalent to	500 mg	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
Kabi	2 g	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
Kabi	1 g	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
Cefepime Hydrochloride And Dextrose	1g/50mL	injection	🇺🇸 US	B. Braun Medical Inc.	Active
Cefepime Hydrochloride And Dextrose	2g/50mL	injection	🇺🇸 US	B. Braun Medical Inc.	Active
Cefepime	1g/50mL	injection	🇺🇸 US	Baxter Healthcare Company	Active
Cefepime	1g/1	injection	🇺🇸 US	Hospira, Inc.	Active

+3 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.