Hydromorphone Hydrochloride shortage — US supply status & alternatives

Hydromorphone Hydrochloride

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🇦🇺 AUST R 303502 · Juno Pharmaceuticals Pty Ltd

In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Yes — under S19A

TGA s19A · hydromorphone-hydrochloride-1mgml-oral-solution-usp-hikma-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Hydromorphone Hydrochloride
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Juno Pharmaceuticals Pty Ltd, Medicianz Healthcare Pty Ltd, HIKMA PHARMACEUTICALS USA INC., Mundipharma Pty Ltd +2 more

Registrations on file	28

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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

✓

Section 19A approval in force · hydromorphone-hydrochloride-1mgml-oral-solution-usp-hikma-usa

TGA Section 19A: overseas-registered 'Hydromorphone Hydrochloride 1mg/mL Oral Solution, USP (Hikma, USA)' approved for import and supply in Australia during a shortage. Origin: Hikma, USA. Expires Jan 2027. Verify on TGA Section 19A approvals ↗

✓

Section 19A approval in force · hydromorphone-hydrochloride-5mg5ml-1mgml-oral-solution-usp-rhodes-usa

TGA Section 19A: overseas-registered 'HYDROmorphone Hydrochloride 5mg/5mL (1mg/mL) Oral Solution, USP (Rhodes, USA)' approved for import and supply in Australia during a shortage. Origin: Rhodes, USA. Expires Feb 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

Chattem Chemicals INCNoramco LLCSiegfried USA LLCSpecgx LLC

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

Hydromorphone Hydrochloride

OurPharma LLC · Apr 2025

Class IIIdetails ↗

🇺🇸

HYDROMORPHONE HYDROCHLORIDE

Pfizer Inc. · Feb 2018

Class Idetails ↗

🇺🇸

HYDROMORPHONE HYDROCHLORIDE

Pfizer Inc. · Feb 2018

Class Idetails ↗

🇺🇸

HYDROMORPHONE HYDROCHLORIDE

Pfizer Inc. · Aug 2017

Class IIdetails ↗

🇺🇸

HYDROMORPHONE HYDROCHLORIDE

HOSPIRA INC, LAKE FOREST · July 2017

Class IIdetails ↗

🇺🇸

HYDROMORPHONE HYDROCHLORIDE

HOSPIRA INC, LAKE FOREST · July 2017

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders28 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
HYDROMORPHONE JUNO-HP hydromorphone hydrochloride	10 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Medicianz Hydromorphone Hp	100 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
HYDROMORPHONE-HAMELN-HP hydromorphone hydrochloride	10 mg	—	🇦🇺 AU	—	Active
HYDROMORPHONE-HAMELN hydromorphone hydrochloride	2 mg	—	🇦🇺 AU	—	Active
Hydromorphone Hydrochloride	1mg/mL	solution	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
DILAUDID hydromorphone hydrochloride	2mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
DILAUDID hydromorphone hydrochloride	4mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
DILAUDID hydromorphone hydrochloride	8mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
DILAUDID-HP hydromorphone hydrochloride	10mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
DILAUDID-HP hydromorphone hydrochloride	50mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
Medicianz Hydromorphone Hp	10 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Medsurge Hydromorphone Xhp	50 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
HYDROMORPHONE JUNO hydromorphone hydrochloride	2 mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Medicianz Hydromorphone Xhp	50 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active
Medsurge Hydromorphone Hp	10 mg	—	🇦🇺 AU	Medicianz Healthcare Pty Ltd	Active

+13 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.