Mycophenolate Mofetil shortage — CA supply status & alternatives

Mycophenolate Mofetil

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🇦🇺 AUST R 327729 · Accord Healthcare Pty Ltd

In supply · Australia

Myfenax

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇺🇸 US🇬🇷 GR🇮🇪 IE

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

Active ingredient (INN)	Mycophenolate Mofetil

Brand names	Myfenax

Therapeutic category	Auto-created by National Organisation for Medicines — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Accord Healthcare Pty Ltd, Pharmacor Pty Ltd, HIKMA PHARMACEUTICALS USA INC., Roche Products Pty Ltd +2 more

Registrations on file	27

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)

—

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

🇬🇧 GB

£5.52

Drug Tariff

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

17 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

Chongqing Daxin Pharmaceutical CO LTDExcella GMBH And CO KgHisun Pharmaceutical Hangzhou CO LTDBiocon LTDChunghwa Chemical Synthesis And Biotech CO LTDConcord Biotech LTD+11 more

Manufacturing countries: China, Germany, Malaysia, Taiwan, India · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

MYCOPHENOLATE MOFETIL

VistaPharm LLC · Oct 2023

Class IIIdetails ↗

🇺🇸

MYCOPHENOLATE MOFETIL

Par Pharmaceutical, Inc. · Apr 2019

Class Idetails ↗

🇺🇸

Mycophenolate Mofetil

Attix Pharmaceuticals Inc · May 2016

Class IIIdetails ↗

🇺🇸

Mycophenolate Mofetil Active Pharmaceutical Ingredient Packa

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

🇺🇸

Mycophenolate Mofetil

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Mycophenolate Mofetil

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
MYCOPHENOLATE INTAS mycophenolate mofetil	500 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
MYCOPHENOLATE ACCORD mycophenolate mofetil	500 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Alcept	500 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Mofit	500 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
Pharmacor Mycophenolate	500 mg	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
PHARMACOR MYCOPHENOLATE mycophenolate mofetil	1g	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
ALCEPT mycophenolate mofetil	1g	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
MYCOCELL mycophenolate mofetil	1g	—	🇦🇺 AU	Pharmacor Pty Ltd	Active
NOUMED MYCOPHENOLATE mycophenolate mofetil	250mg	—	🇦🇺 AU	—	Active
Mycophenolate Mofetil	250mg/1	capsule	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Mycophenolate Mofetil	500mg/1	tablet	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
CELLCEPT mycophenolate mofetil	250mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active
CELLCEPT mycophenolate mofetil	500mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active
CELLCEPT mycophenolate mofetil	200mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active
CELLCEPT mycophenolate mofetil	500 mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active

+12 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.