Afatinib — supply status, manufacturers & alternatives

Afatinib

ATC L01EB03

🇦🇺 AUST R 201318 · Boehringer Ingelheim Pty Ltd

In supply · Australia

Giotrif

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$2587.80DPMQ A$2771.92details →

✓ 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)

Brand names	Giotrif

ATC level 5	L01EB03

ATC level 4	L01EB

Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	Boehringer Ingelheim Pty Ltd, SANDOZ CANADA INCORPORATED, MARCAN PHARMACEUTICALS INC, TEVA CANADA LIMITED

Registrations on file	7

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$2587.80

AEMP

Dispensed (DPMQ)

A$2771.92

incl. fees

Pack

afatinib 20 mg tablet, 28

Source: PBSEffective July 2026 · AUD

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

Msn Laboratories Private LTDShandong Anhong Pharmaceutical CO LTDTapi Nl BVSun Pharmaceutical Industries LTDHetero Labs LTDAlembic Pharmaceuticals LTD+1 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders7 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
GIOTRIF afatinib	30 mg	—	🇦🇺 AU	Boehringer Ingelheim Pty Ltd	Active
GIOTRIF afatinib	20 mg	—	🇦🇺 AU	Boehringer Ingelheim Pty Ltd	Active
GIOTRIF afatinib	40 mg	—	🇦🇺 AU	Boehringer Ingelheim Pty Ltd	Active
GIOTRIF afatinib	50 mg	—	🇦🇺 AU	Boehringer Ingelheim Pty Ltd	Active
Sandoz Afatinib	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Mar-Afatinib	—	tablet	🇨🇦 CA	MARCAN PHARMACEUTICALS INC	Active
Teva-Afatinib	—	tablet	🇨🇦 CA	TEVA CANADA 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.