Amikacin — supply status, manufacturers & alternatives

Amikacin

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🇦🇺 AUST R 401535 · Medicianz Healthcare Pty Ltd

Anticipated · Australia

WockhardtAmikacin SulfateAmikacine Viatris

Anticipated · 🇦🇺 Australia

Anticipated shortage

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Nov 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Amikacin
Brand names	Wockhardt, Amikacin Sulfate, Amikacine Viatris
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Marketing-authorisation holders	Medicianz Healthcare Pty Ltd, Fresenius Kabi Australia Pty Ltd, HAMELN PHARMA LTD, Hospira UK Limited +9 more

Registrations on file	21

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)

—

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.

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

1 API manufacturer

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.

Very high concentration risk

Acs Dobfar SPA

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

Recalls official enforcement reports

🇺🇸

Amikacin

Sentara Infusion Services · Dec 2022

Class IIdetails ↗

🇺🇸

Amikacin

Main Street Family Pharmacy, LLC · May 2013

Class IIdetails ↗

🇺🇸

Amikacin

Main Street Family Pharmacy, LLC · May 2013

Class IIdetails ↗

🇺🇸

Amikacin

Main Street Family Pharmacy, LLC · May 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders21 registrations · 13 MA holders

Product	Strength	Form	Market	MA holder	Status
Medicianz	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Medsurge	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Kabi	1000 mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
Kabi	250 mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
Kabi	500 mg	—	🇦🇺 AU	Fresenius Kabi Australia Pty Ltd	Active
AMIKACIN 250 MG/ML SOLUTION FOR INJECTION/INFUSION	250 MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
AMIKACIN 250MG/ML INJECTION	250MG	injection	🇬🇧 GB	Hospira UK Limited	Active
Amikacin Kabi	5 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
AMIKACIN 250MG/ML SOLUTION FOR INJECTION/INFUSION	250MG	injection	🇬🇧 GB	NEON HEALTHCARE LIMITED	Active
AMIKACIN 125 MG/ML SOLUTION FOR INJECTION/INFUSION	125 MG	injection	🇬🇧 GB	DEMO PHARMA UK LIMITED	Active
AMIKACIN 250 MG/ML SOLUTION FOR INJECTION/ INFUSION	250 MG	injection	🇬🇧 GB	GALVANY PHARMA LIMITED	Active
Dbl Amikacin	500mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
Sxp	500 mg	—	🇦🇺 AU	—	Active
Rmb	500 mg	—	🇦🇺 AU	—	Active
Ajs	500 mg	—	🇦🇺 AU	—	Active

+6 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.