Fulvestrant shortage — IT supply status & alternatives

Fulvestrant

—

🇦🇺 AUST R 349711 · Interpharma Pty Ltd

In supply · Australia

Faslodex

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇪🇸 ES🇧🇪 BE🌐 HR

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$134.60DPMQ A$156.77details →

✓ 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

Active ingredient (INN)	Fulvestrant
Brand names	Faslodex
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper
Controlled substance	No
Marketing-authorisation holders	Interpharma Pty Ltd, Accord Healthcare Pty Ltd, AFT Pharmaceuticals Pty Ltd, HIKMA PHARMACEUTICALS USA INC. +3 more
Registrations on file	11
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$134.60

AEMP

Dispensed (DPMQ)

A$156.77

incl. fees

Pack

fulvestrant 250 mg/5 mL injection, 2 x 5 mL syringes

Source: PBSEffective July 2026 · AUD

Other markets

🇪🇸 ES

€225.70

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

14 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

Farmabios SPAScinopharm Taiwan LTDTapi Nl BVSterling SPAIndustriale Chimica SrlWavelength Enterprises LTD+8 more

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

Shortage status by regulator official notices

🇮🇹

Italy

AIFA · 10h ago

Critical

🇧🇪

FAMHP · 4h ago

Medium

🌐

HALMED · 22h ago

Medium

🇪🇸

Spain

AEMPS · 1mo ago

Medium

Recalls official enforcement reports

🇺🇸

FULVESTRANT

Zydus Pharmaceuticals (USA) Inc · July 2022

Class IIdetails ↗

🇺🇸

FULVESTRANT

Glenmark Pharmaceuticals Inc., USA · Aug 2021

Class IIdetails ↗

Verified timeline regulator events

🇧🇪 16 June 2026

medium reported

🇮🇹 31 May 2026

critical reported

🇮🇹 1 May 2026

Shortage resolved

🌐 22 Dec 2025

medium reported

🇮🇹 30 Aug 2025

critical reported

🇪🇸 13 May 2025

medium reported

Sources official regulators

🇧🇪

FAMHP

verified 4h ago

verify ↗

🇮🇹

AIFA

verified 10h ago

verify ↗

🌐

HALMED

verified 22h ago

verify ↗

🇪🇸

AEMPS

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders11 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Ever Pharma	250 mg	—	🇦🇺 AU	Interpharma Pty Ltd	Active
Accord	250 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Intas	250 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Aft	250 mg	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
Eug	250 mg	—	🇦🇺 AU	—	Active
Eugia	250 mg	—	🇦🇺 AU	—	Active
Epsl	250 mg	—	🇦🇺 AU	—	Active
Fulvestrant	50mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
FASLODEX fulvestrant	250mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Sandoz	250 mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
FULVESTRANT	250mg/5mL	injection	🇺🇸 US	Accord Healthcare Inc.	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.