Tranexamic Acid shortage — CA supply status & alternatives

Tranexamic Acid

—

🇦🇺 AUST R 272727 · Southern Cross Pharma Pty Ltd

In supply · Australia

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$23.84DPMQ A$39.23details →

✓ Can I substitute?

Yes — under S19A

TGA s19A · tranexamic-acid-500mg-tablets-manx-healthcare-uk

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)

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

Controlled substance	No

Marketing-authorisation holders	Pfizer Limited, BAXTER HEALTHCARE LIMITED, SANDOZ LIMITED, TILLOMED LABORATORIES LIMITED +10 more

Registrations on file	18

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · tranexamic-acid-500mg-tablets-manx-healthcare-uk

TGA Section 19A: overseas-registered 'Tranexamic acid 500mg tablets (Manx Healthcare, UK)' approved for import and supply in Australia during a shortage. Expires Aug 2026. Verify on TGA Section 19A approvals ↗

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

10 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✓ 1 WHO-prequalified

Shilpa Pharma Lifesciences LTDAmi Lifesciences Private LimitedHunan Dongting Pharmaceutical CO LTDAlp Pharm Beijing CO LTDAsahi Kasei Finechem CO LTDKyowa Pharma Chemical CO LTD+4 more

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

Recalls official enforcement reports

🇺🇸

TRANEXAMIC ACID

AVKARE LLC · June 2023

Class IIIdetails ↗

🇺🇸

TRANEXAMIC ACID

Amring Pharmaceuticals Inc · June 2023

Class IIIdetails ↗

🇺🇸

TRANEXAMIC ACID

AuroMedics Pharma LLC · Sept 2022

Class IIIdetails ↗

🇺🇸

TRANEXAMIC ACID

Mylan Institutional LLC · Aug 2020

Class Idetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 14 MA holders

Product	Strength	Form	Market	MA holder	Status
Tranexamic Acid Pfizer	100 MG	injection	🇬🇧 GB	Pfizer Limited	Active
TRANEXAMIC ACID 100MG/ML SOLUTION FOR INJECTION/INFUSION	100MG	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
TRANEXAMIC ACID 500MG TABLETS	500MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
Tranexamic Acid Tillomed	500 MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
TRANEXAMIC ACID 10 MG/ML SOLUTION FOR INFUSION	10 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
Apo	500 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
Scp	500 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
Lupin	500 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
TRANEXAMIC ACID 100 MG/ML SOLUTION FOR INJECTION	100 MG	injection	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
TRANEXAMIC ACID 100MG/ML SOLUTION FOR INJECTION	100MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
TRANEXAMIC ACID 500MG/5ML SOLUTION FOR INJECTION	500MG	injection	🇬🇧 GB	FOCUS PHARMACEUTICALS LIMITED	Active
TRANEXAMIC ACID 500 MG FILM-COATED TABLETS	500 MG	tablet	🇬🇧 GB	RELONCHEM LIMITED	Active
TRANEXAMIC ACID 100 MG/ML SOLUTION FOR INJECTION/INFUSION	100 MG	injection	🇬🇧 GB	STRAGEN UK LIMITED	Active
TRANEXAMIC ACID 500 MG FILM COATED TABLETS	500 MG	tablet	🇬🇧 GB	DAWA LIMITED	Active
Tranexamic Acid Rivopharm	500 MG	tablet	🇬🇧 GB	RIVOPHARM (UK) LIMITED	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.