Fosfomycin Tromethamine — supply status, manufacturers & alternatives

Fosfomycin Tromethamine

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In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Marketing-authorisation holders
Active ingredient (INN)	Fosfomycin Tromethamine
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No

Registrations on file	1

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)

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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.

Substitution pathways 🇦🇺 Australia · TGA

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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

4 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

Honour Lab LimitedErcros SAQuimica Sintetica SAMsn Organics Private LTD

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

Recalls official enforcement reports

🇺🇸

FOSFOMYCIN TROMETHAMINE

Ascend Laboratories, LLC · Jan 2024

Class IIdetails ↗

🇺🇸

FOSFOMYCIN TROMETHAMINE

Ascend Laboratories, LLC · July 2023

Class IIIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders1 registration · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
FOSFOMYCIN TROMETHAMINE	3g/1	powder	🇺🇸 US	A-S Medication Solutions	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.