Imipramine shortage — FR supply status & alternatives

Imipramine

—

🇦🇺 AUST R 11064 · Amdipharm Mercury Australia Pty Ltd

In supply · Australia

Tofranil

In supply · 🇦🇺 Australia · short in🇫🇷 FR🇳🇿 NZ

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.97DPMQ A$18.57details →

✓ Can I substitute?

Yes — approved substitute available

TGA s19A · imipramine-hcl-tablets-usp-10mg-100-tablets-leading-pharma-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Imipramine

Brand names	Tofranil

Therapeutic category	Auto-created by Agence nationale de sécurité du médicament — Disponibilité scraper

Controlled substance	No

Marketing-authorisation holders	ACCORD-UK LIMITED, TILLOMED LABORATORIES LIMITED, MILPHARM LIMITED, ZENTIVA PHARMA UK LIMITED +8 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$3.97

AEMP

Dispensed (DPMQ)

A$18.57

incl. fees

Pack

imipramine hydrochloride 10 mg tablet, 50

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£2.21

Drug Tariff

🇺🇸 US

US$3.56

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · imipramine-hcl-tablets-usp-10mg-100-tablets-leading-pharma-usa

TGA Section 19A: overseas-registered 'Imipramine HCL Tablets, USP 10mg 100 Tablets (Leading Pharma, USA)' approved for import and supply in Australia during a shortage. Origin: Leading Pharma, USA. Expires Aug 2026. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · imipramine-hcl-tablets-usp-25mg-100-tablets-leading-pharma-usa

TGA Section 19A: overseas-registered 'Imipramine HCL tablets, USP 25mg 100 tablets (Leading Pharma, USA)' approved for import and supply in Australia during a shortage. Expires Apr 2027. Verify on TGA Section 19A approvals ↗

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

4 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

Tapi Nl BVRl Fine Chem PVT LTDLupin LTDLundbeck Pharmaceuticals Italy SPA

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders22 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
Imipramine Tablets Bp	10MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Imipramine Tablets Bp	25MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
IMIPRAMINE 25MG TABLETS	25MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Trimipramine	50MG	capsule	🇬🇧 GB	MILPHARM LIMITED	Active
Trimipramine	10MG	tablet	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
Trimipramine	25MG	tablet	🇬🇧 GB	ZENTIVA PHARMA UK LIMITED	Active
IMIPRAMINE 10 MG TABLETS	10 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
IMIPRAMINE 25 MG TABLETS	25 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Imipramine Hcl	10MG	imipramine	🇬🇧 GB	CHELONIA HEALTHCARE LIMITED	Active
Imipramine Hcl	25MG	imipramine	🇬🇧 GB	CHELONIA HEALTHCARE LIMITED	Active
Imipramine Hydrochloride	25MG	solution	🇬🇧 GB	Essential Pharma Limited	Active
IMIPRAMINE 10MG TABLETS BP	10MG	tablet	🇬🇧 GB	KENT PHARMA UK LIMITED	Active
IMIPRAMINE 25MG TABLETS BP	25MG	tablet	🇬🇧 GB	KENT PHARMA UK LIMITED	Active
Imipramine Pamoate	75mg/1	capsule	🇺🇸 US	Hikma Pharmaceuticals USA Inc	Active
Imipramine Pamoate	100mg/1	capsule	🇺🇸 US	Hikma Pharmaceuticals USA Inc	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.