Phenytoin Sodium shortage — CA supply status & alternatives

Phenytoin Sodium

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🇦🇺 AUST R 117865 · Juno Pharmaceuticals Pty Ltd

In supply · Australia

Dilantin

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇳🇿 NZ

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

Therapeutic category
Active ingredient (INN)	Phenytoin Sodium
Brand names	Dilantin

Controlled substance	No

Marketing-authorisation holders	Generics (UK) Limited, FLYNN PHARMA LIMITED, MERCURY PHARMACEUTICALS LIMITED, MILPHARM LIMITED +6 more

Registrations on file	18

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.

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

Recordati Industria Chimica E Farmaceutica SPAErredue SPA Innovative Chemical And LifeHarman Finochem LTDKunshan Oriental Pharmaceutical CO LTDOrchid Pharma LTDUnichem Laboratories LTD

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

Recalls official enforcement reports

🇺🇸

EXTENDED PHENYTOIN SODIUM

Amneal Pharmaceuticals of New York, LLC · Oct 2023

Class IIdetails ↗

🇺🇸

EXTENDED PHENYTOIN SODIUM

Amneal Pharmaceuticals of New York, LLC · May 2023

Class IIdetails ↗

🇺🇸

PHENYTOIN SODIUM

Acella Pharmaceuticals, LLC · Nov 2022

Class IIIdetails ↗

🇺🇸

PHENYTOIN SODIUM

Acella Pharmaceuticals, LLC · Nov 2022

Class IIIdetails ↗

🇺🇸

EXTENDED PHENYTOIN SODIUM

Amneal Pharmaceuticals of New York, LLC. · Aug 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
Phenytoin Sodium Mylan	25 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	50 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	100 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	300 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Flynn	25 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	50 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	100 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	300 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
PHENYTOIN SODIUM 50MG/ML SOLUTION FOR INJECTION	50MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Phenytoin Sodium Milpharm	100MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Fosphenytoin Sodium	50mg/mL	injection	🇺🇸 US	West-Ward Pharmaceuticals Corp	Active
Phenytoin Juno	250mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Phenytoin Juno	100mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
DILANTIN phenytoin sodium	100 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
DILANTIN phenytoin sodium	30 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	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.