Hydroquinone — supply status, manufacturers & alternatives

Hydroquinone

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In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ 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)	Hydroquinone
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No
Marketing-authorisation holders	Marlex Pharmaceuticals, Inc., APNAR PHARMA LP, Acella Pharmaceuticals, LLC, ZO Skin Health, Inc. +2 more

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

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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.

Other markets

🇺🇸 US

US$0.44

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

Eastman Chemical COGlobal Calcium Private LTDApionex Pharma PVT LTD

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

Recalls official enforcement reports

🇺🇸

HYDROQUINONE

Monarch PCM, LLC · Sept 2021

Class IIdetails ↗

🇺🇸

HYDROQUINONE

Monarch PCM, LLC · Sept 2021

Class IIIdetails ↗

🇺🇸

Hydroquinone

KRS Global Biotechnology, Inc · Nov 2017

Class IIdetails ↗

🇺🇸

Hydroquinone

Synergy Rx · Feb 2017

Class IIdetails ↗

🇺🇸

Hydroquinone

Health Innovations Pharmacy, Inc · Feb 2015

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders9 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
hydroquinone	40mg/g	cream	🇺🇸 US	Marlex Pharmaceuticals, Inc.	Active
Hydroquinone cream	40mg/g	cream	🇺🇸 US	APNAR PHARMA LP	Active
Hydroquinone 4%	40mg/g	cream	🇺🇸 US	Acella Pharmaceuticals, LLC	Active
ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C	.04mg/mL	emulsion	🇺🇸 US	ZO Skin Health, Inc.	Active
ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone	.04g/mL	emulsion	🇺🇸 US	ZO Skin Health, Inc.	Active
ZO Skin Health Pigment Control Creme Hydroquinone	40mg/mL	emulsion	🇺🇸 US	ZO Skin Health, Inc.	Active
ZO Skin Health Pigment Control Program Plus Hydroquinone	—	kit	🇺🇸 US	ZO Skin Health, Inc.	Active
Erfa Hydroquinone	—	gel	🇨🇦 CA	SEARCHLIGHT PHARMA INC	Active
Ultraquin 4% Hydroquinone Cream With Sunscreens	4%	cream	🇨🇦 CA	SANOFI CONSUMER HEALTH 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.