Mifepristone — supply status, manufacturers & alternatives

Mifepristone

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🇦🇺 AUST R 175671 · MS Health Pty Ltd

In supply · Australia

Mifegyne

In supply · 🇦🇺 Australia

In supply in Australia

No active shortage reported.

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)	Mifepristone
Brand names	Mifegyne
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV, NORDIC GROUP BV, MS Health Pty Ltd, ACTAVIS PHARMA, INC. +1 more

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

5 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✓ 1 WHO-prequalified

Qinhuangdao Zizhu Pharmaceutical Co LtdFormosa Laboratories INCZhejiang Xianju Pharmaceutical CO LTDNaari Pte LTDCuria Spain Sau

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders6 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
Medabon: Combipack Of Mifepristone	200 MG	tablet	🇬🇧 GB	SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	Active
Mifepristone Linepharma	200 MG	tablet	🇬🇧 GB	NORDIC GROUP BV	Active
Mifepristone Linepharma	200 MG	—	🇦🇺 AU	MS Health Pty Ltd	Active
Ms-	200 MG	—	🇦🇺 AU	MS Health Pty Ltd	Active
Mifepristone	300mg/1	tablet	🇺🇸 US	ACTAVIS PHARMA, INC.	Active
Mifepristone	200mg/1	tablet	🇺🇸 US	GenBioPro, 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.