Eslicarbazepine Acetate — supply status, manufacturers & alternatives

Eslicarbazepine Acetate

ATC N03AF04

In supply · Australia

Aptiom

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

ATC level 5
Active ingredient (INN)	Eslicarbazepine Acetate
Brand names	Aptiom

ATC level 4	N03AF

Therapeutic category	Auto-created by Health Canada backfill

Controlled substance	No

Marketing-authorisation holders	TORRENT PHARMACEUTICALS LIMITED

Registrations on file	4

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

17 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

Arene Life Sciences LTDAmi Lifesciences Private LTDLupin Manufacturing Solutions LTDBial Portela And Ca SAJubilant Biosys LTDCtx Life Sciences PVT LTD+11 more

Manufacturing countries: India, Portugal, Canada, China, Taiwan · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders4 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
Eslicarbazepine acetate	200mg/1	tablet	🇺🇸 US	TORRENT PHARMACEUTICALS LIMITED	Active
Eslicarbazepine acetate	400mg/1	tablet	🇺🇸 US	TORRENT PHARMACEUTICALS LIMITED	Active
Eslicarbazepine acetate	600mg/1	tablet	🇺🇸 US	TORRENT PHARMACEUTICALS LIMITED	Active
Eslicarbazepine acetate	800mg/1	tablet	🇺🇸 US	TORRENT PHARMACEUTICALS 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.