Amikacin Sulfate — supply status, manufacturers & alternatives

Amikacin Sulfate

ATC D06AX12

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)	Amikacin Sulfate
ATC level 5	D06AX12
ATC level 4	D06AX
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Marketing-authorisation holders	HIKMA PHARMACEUTICALS USA INC., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., SANDOZ CANADA INCORPORATED, OMEGA LABORATORIES LIMITED

Registrations on file	5

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.

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

2 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.

High concentration risk

Acs Dobfar SPAShandong Anxin Pharmaceutical CO LTD

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

Recalls official enforcement reports

🇺🇸

AMIKACIN SULFATE

Heritage Pharmaceuticals, Inc. · May 2019

Class Idetails ↗

🇺🇸

Amikacin Sulfate

Lowlite Investments, Inc. D/B/A Olympia Pharmacy · May 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders5 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Amikacin Sulfate	250mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Amikacin Sulfate	500mg/2mL	injection	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
Amikacin Sulfate	1g/4mL	injection	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
Amikacin Sulfate Injection Usp	—	liquid	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
AMIKACIN SULFATE INJECTION	—	solution	🇨🇦 CA	OMEGA LABORATORIES LIMITED	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.