Betahistine shortage — CA supply status & alternatives

Betahistine

ATC N07CA01

🇦🇺 AUST R 367216 · Southern Cross Pharma Pty Ltd

In supply · Australia

LUPIN betahistine dihydrochloride

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)	Betahistine
Brand names	LUPIN betahistine dihydrochloride
ATC level 5	N07CA01

Therapeutic category	Auto-created by Health Canada — Recalls and Safety Alerts scraper

Controlled substance	No

Marketing-authorisation holders	Southern Cross Pharma Pty Ltd, Generics (UK) Limited, KENT PHARMACEUTICALS LIMITED, TILLOMED LABORATORIES LIMITED +1 more

Registrations on file	13

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

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

£1.10

Drug Tariff

🇫🇷 FR

€5.91

Retail price

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

Olon SPAHenan Purui Pharmaceutical CO LTDMaithri Laboratories Private LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders13 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
SCP betahistine dihydrochloride	16mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
RMB betahistine dihydrochloride	16mg	—	🇦🇺 AU	—	Active
SETEAR betahistine dihydrochloride	16mg	—	🇦🇺 AU	—	Active
LUPIN betahistine dihydrochloride	16mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
Betahistine Dihydrochloride	8MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Betahistine Dihydrochloride	16MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Betahistine Hydrochloride	8MG	tablet	🇬🇧 GB	KENT PHARMACEUTICALS LIMITED	Active
Betahistine Hydrochloride	16MG	tablet	🇬🇧 GB	KENT PHARMACEUTICALS LIMITED	Active
Betahistine Dihydrochloride	8 MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Betahistine Dihydrochloride	16 MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Betahistine Dihydrochloride	24 MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
BETAHISTINE 8 MG TABLETS	8 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
BETAHISTINE 16 MG TABLETS	16 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	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.