Fluphenazine Hydrochloride shortage — US supply status & alternatives

Fluphenazine Hydrochloride

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Anticipated · Australia

Anticipated · 🇦🇺 Australia & also short in🇺🇸 US🇨🇦 CA

Anticipated shortage

Reading today’s signals…

• Can I substitute?

No pathway on record

prescriber decision required

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

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

Marketing-authorisation holders	PAI Holdings, LLC dba PAI Pharma, Lannett Company, Inc.

Registrations on file	6

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

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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

8 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 Life Sciences Private LTDBiophore India Pharmaceuticals PVT LTDFine Chemicals Corp Pty LTDRaks Pharma PVT LTDEnaltec Labs Private LTDAlembic Pharmaceuticals LTD+2 more

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

Recalls official enforcement reports

🇺🇸

FLUPHENAZINE HYDROCHLORIDE

Glenmark Pharmaceuticals Inc., USA · Mar 2025

Class IIdetails ↗

🇺🇸

FLUPHENAZINE HYDROCHLORIDE

Glenmark Pharmaceuticals Inc., USA · Mar 2025

Class IIdetails ↗

🇦🇺

Fluphenazine deconate (Neuraxpharm) 25mg/1mL soln for IM inj amp (1mLx5)

Link Medical Products Pty Ltd T/A Link Pharmaceuticals · June 2023

Class Idetails ↗

🇺🇸

Fluphenazine Decanoate Active Pharmaceutical Ingredient Pack

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

🇺🇸

Fluphenazine Hcl Active Pharmaceutical Ingredient Packaged I

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 12 May 2026

medium reported

🇺🇸 18 Sept 2025

medium reported

🇺🇸 18 Sept 2025

medium reported

🇺🇸 13 Mar 2025

high reported

🇦🇺 22 June 2023

high reported

🇺🇸 29 May 2013

high reported

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇺🇸

FDA

verified 2h ago

verify ↗

🇦🇺

TGA Recalls

verified 3mo ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders6 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
Fluphenazine Hydrochloride	5mg/mL	solution	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Fluphenazine Hydrochloride	.5mg/mL	elixir	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active
Fluphenazine Hydrochloride	1mg/1	tablet	🇺🇸 US	Lannett Company, Inc.	Active
Fluphenazine Hydrochloride	2.5mg/1	tablet	🇺🇸 US	Lannett Company, Inc.	Active
Fluphenazine Hydrochloride	5mg/1	tablet	🇺🇸 US	Lannett Company, Inc.	Active
Fluphenazine Hydrochloride	10mg/1	tablet	🇺🇸 US	Lannett Company, 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.