Sotalol Hydrochloride shortage — CA supply status & alternatives

Sotalol Hydrochloride

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🇦🇺 AUST R 333531

Anticipated · Australia

Jamp-Sotalol

Anticipated · 🇦🇺 Australia & also short in🇨🇦 CA🇳🇱 NL

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)	Sotalol Hydrochloride

Brand names	Jamp-Sotalol

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	TILLOMED LABORATORIES LIMITED, CRESCENT PHARMA LIMITED, TEVA PHARMACEUTICALS USA, INC., Alphapharm Pty Ltd +2 more

Registrations on file	23

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.

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

Siegfried LTDNeuland Laboratories LTDApisyn Healthcare Private LTD

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

Recalls official enforcement reports

🇦🇺

Sotalol Carinopharm 40 mg / 4 ml solution for injectionBatch Number: 015333Expiry Date: 01/2022Suppl

Medsurge Healthcare Pty Ltd · Mar 2020

Class Idetails ↗

🇺🇸

Sotalol Hcl

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Sotalol Hcl

Aidapak Services, LLC · July 2013

Class IIdetails ↗

🇺🇸

Sotalol Hcl

Aidapak Services, LLC · July 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders23 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
APX-SOTALOL sotalol hydrochloride	80 mg	—	🇦🇺 AU	—	Active
APX-SOTALOL sotalol hydrochloride	160 mg	—	🇦🇺 AU	—	Active
SOTALOL HYDROCHLORIDE 40MG TABLETS	40MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
SOTALOL HYDROCHLORIDE 80MG TABLETS	80MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
SOTALOL HYDROCHLORIDE 160MG TABLETS	160MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Sotalol Hydrochloride	120mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Sotalol Hydrochloride	80mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Sotalol Hydrochloride	160mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Sotalol Hydrochloride	240mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
CARDOL sotalol hydrochloride	160mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
SOTALOL SANDOZ Sotalol hydrochloride	160mg	—	🇦🇺 AU	Sandoz Pty Ltd	Active
SOTACOR sotalol hydrochloride	80mg	—	🇦🇺 AU	—	Active
SOTACOR sotalol hydrochloride	160mg	—	🇦🇺 AU	—	Active
APO-SOTALOL sotalol hydrochloride	160mg	—	🇦🇺 AU	—	Active
SOTAB Sotalol hydrochloride	160mg	tabuc	🇦🇺 AU	Medis Pharma Pty Ltd	Active

+8 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.