Amitriptyline shortage — CA supply status & alternatives

Amitriptyline

ATC N06AA09

🇦🇺 AUST R 333515

In supply · Australia

WHO Essential Medicine

Bio-Amitriptyline

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$2.83DPMQ A$17.43details →

✓ 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

Active ingredient (INN)	Amitriptyline
Brand names	Bio-Amitriptyline
ATC level 5	N06AA09
ATC level 4	N06AA
Therapeutic category	Canonical INN head (inn_resolution)
WHO Essential Medicine	Yes · 2.3. Medicines for other common symptoms in palliative care (2023)
Controlled substance	No
Marketing-authorisation holders	Ipca Pharma (Australia) Pty Ltd, ACCORD-UK LIMITED, TEVA UK LIMITED, ROSEMONT PHARMACEUTICALS LIMITED +5 more
Registrations on file	22
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$2.83

AEMP

Dispensed (DPMQ)

A$17.43

incl. fees

Pack

amitriptyline hydrochloride 10 mg tablet, 50

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.73

Drug Tariff

🇺🇸 US

US$0.29

Acquisition

🇫🇷 FR

€3.36

Retail price

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

2 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.

High concentration risk

Olon SPATapi Nl BV

Country of manufacture not yet mapped · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇨🇦

Amitriptyline 10 mg tablets (Updated 2023

Communications and Public Affairs Branch · Feb 2023

Class ?details ↗

🇺🇸

Amitriptyline Hcl Usp For Prescription Compounding

American Pharmaceutical Ingredients LLC · Feb 2018

Class IIdetails ↗

🇺🇸

Amitriptyline Hcl Active Pharmaceutical Ingredient Packaged

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders22 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
ARX amitriptyline hydrochloride	50 mg	—	🇦🇺 AU	—	Active
ARX amitriptyline hydrochloride	25 mg	—	🇦🇺 AU	—	Active
SANDOZ amitriptyline hydrochloride	10mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
SANDOZ amitriptyline hydrochloride	25mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
SANDOZ amitriptyline hydrochloride	50mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
PPA-AMITRIPTYLINE amitriptyline hydrochloride	10mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
Amitriptyline Tablets Bp	10 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Amitriptyline Tablets Bp	25MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Amitriptyline Tablets Bp	50MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
AMITRIPTYLINE 10MG FILM-COATED TABLETS	10MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
AMITRIPTYLINE 25MG FILM-COATED TABLETS	25MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
AMITRIPTYLINE 50MG FILM-COATED TABLETS	50MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Amitriptyline Hydrochloride	25MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Amitriptyline Hydrochloride	50MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
GPPL amitriptyline hydrochloride	10 mg	tab	🇦🇺 AU	—	Active

+7 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.