Dantrolene Sodium shortage — CA supply status & alternatives

Dantrolene Sodium

ATC M03CA01

🇦🇺 AUST R 14435 · Pfizer Australia Pty Ltd

In supply · Australia

Revonto

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

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Yes — approved substitute available

TGA s19A · revonto-dantrolene-sodium-injection-20-mgvial-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Dantrolene Sodium
Brand names	Revonto
ATC level 5	M03CA01

ATC level 4	M03CA

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

Controlled substance	No

Marketing-authorisation holders	Amneal Pharmaceuticals of New York LLC, Pfizer Australia Pty Ltd, HIKMA CANADA LIMITED

Registrations on file	7

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

🇺🇸 US

US$0.85

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · revonto-dantrolene-sodium-injection-20-mgvial-usa

TGA Section 19A: overseas-registered 'REVONTO dantrolene sodium for injection 20 mg/vial (USA)' approved for import and supply in Australia during a shortage. Origin: USA. Expires Oct 2026. Verify on TGA Section 19A approvals ↗

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

Jinan Jinda Pharmaceutical Chemistry CO LTDScinopharm Taiwan LTDHas Healthcare Advanced Synthesis SAVeranova LPBiophore India Pharmaceuticals PVT LTDGland Pharma LTD

Manufacturing countries: Taiwan, Switzerland, United States, India · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders7 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
Dantrolene Sodium	25mg/1	capsule	🇺🇸 US	Amneal Pharmaceuticals of New York LLC	Active
Dantrolene Sodium	50mg/1	capsule	🇺🇸 US	Amneal Pharmaceuticals of New York LLC	Active
Dantrolene Sodium	100mg/1	capsule	🇺🇸 US	Amneal Pharmaceuticals of New York LLC	Active
DANTRIUM dantrolene sodium hemiheptahydrate	20mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
DANTRIUM dantrolene sodium hemiheptahydrate	25mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
DANTRIUM dantrolene sodium hemiheptahydrate	50mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
Dantrolene Sodium For Injection, Usp	—	solution	🇨🇦 CA	HIKMA CANADA 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.