Clomipramine Hydrochloride shortage — CA supply status & alternatives

Clomipramine Hydrochloride

ATC N06AA04

🇦🇺 AUST R 423112

In supply · Australia

Anafranil

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇫🇷 FR

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

ATC level 5
Active ingredient (INN)	Clomipramine Hydrochloride
Brand names	Anafranil

ATC level 4	N06AA

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	Pharmaco Australia Ltd, Alphapharm Pty Ltd, SpecGx LLC

Registrations on file	8

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

7 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

Biophore India Pharmaceuticals PVT LTDSigma Aldrich Ireland LTDLundbeck Pharmaceuticals Italy SPATaro Pharmaceutical Industries LTDRl Fine Chem PVT LTDSun Pharmaceutical Industries LTD+1 more

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

Recalls official enforcement reports

🇺🇸

CLOMIPRAMINE HYDROCHLORIDE

Zydus Pharmaceuticals (USA) Inc · Oct 2025

Class IIdetails ↗

🇺🇸

CLOMIPRAMINE HYDROCHLORIDE

Zydus Pharmaceuticals (USA) Inc · Oct 2025

Class IIdetails ↗

🇺🇸

CLOMIPRAMINE HYDROCHLORIDE

Zydus Pharmaceuticals (USA) Inc · Oct 2025

Class IIdetails ↗

🇺🇸

CLOMIPRAMINE HYDROCHLORIDE

Leading Pharma, LLC · Aug 2022

Class IIIdetails ↗

🇺🇸

Clomipramine Hci Active Pharmaceutical Ingredient Packaged I

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 2 June 2026

medium reported

🇫🇷 10 Apr 2026

medium reported

🇨🇦 24 Mar 2026

medium reported

🇨🇦 23 Mar 2026

medium reported

🇨🇦 13 Jan 2026

medium reported

🇨🇦 1 Jan 2026

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders8 registrations · 3 MA holders

Product	Strength	Form	Market	MA holder	Status
CLOMIPRAMINE-WGR clomipramine hydrochloride	25mg	—	🇦🇺 AU	—	Active
CLOMIPRAMINE-RJIC clomipramine hydrochloride	25mg	—	🇦🇺 AU	—	Active
ANAFRANIL clomipramine hydrochloride	25mg	—	🇦🇺 AU	Pharmaco Australia Ltd	Active
APO-CLOMIPRAMINE clomipramine hydrochloride	25mg	—	🇦🇺 AU	—	Active
PLACIL clomipramine hydrochloride	25mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
CLOMIPRAMINE HYDROCHLORIDE	25mg/1	capsule	🇺🇸 US	SpecGx LLC	Active
CLOMIPRAMINE HYDROCHLORIDE	50mg/1	capsule	🇺🇸 US	SpecGx LLC	Active
CLOMIPRAMINE HYDROCHLORIDE	75mg/1	capsule	🇺🇸 US	SpecGx LLC	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.