Hydroxyurea shortage — CA supply status & alternatives

Hydroxyurea

—

🇦🇺 AUST R 47486 · Link Medical Products Pty Ltd T/A Link Pharmaceuticals

In supply · Australia

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

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

Marketing-authorisation holders
Active ingredient (INN)	Hydroxyurea
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No

Registrations on file	9

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.

Other markets

🇺🇸 US

US$4.95

Acquisition

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

3 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 SPAArchimica SPAShandong Anxin Pharmaceutical CO LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
HYDREA hydroxycarbamide	500 mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
HYDROXYCARBAMIDE MEDICIANZ hydroxycarbamide	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
HYDROXYCARBAMIDE MEDSURGE hydroxycarbamide	500 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
HYDROXYUREA	500mg/1	capsule	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Mylan-Hydroxyurea	—	capsule	🇨🇦 CA	MYLAN PHARMACEUTICALS ULC	Active
Apo-Hydroxyurea	—	capsule	🇨🇦 CA	APOTEX INC	Active
Riva-Hydroxyurea	—	capsule	🇨🇦 CA	LABORATOIRE RIVA INC.	Active
Eugia-Hydroxyurea	—	capsule	🇨🇦 CA	EUGIA PHARMA INC.	Active
HYDROXYUREA	—	capsule	🇨🇦 CA	SANIS HEALTH INC	Cancelled

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.