Ranitidine shortage — US supply status & alternatives

Ranitidine

ATC A02BA02

🇦🇺 AUST R 311750

In supply · Australia

WHO Essential Medicine

Acid ReducerAurobindo Ranitidine

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.50DPMQ A$18.10details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Omeprazole

Product attributes reference data we hold

Active ingredient (INN)	Ranitidine
Brand names	Acid Reducer, Aurobindo Ranitidine
ATC level 5	A02BA02
ATC level 4	A02BA
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
WHO Essential Medicine	Yes (2023)
Controlled substance	No
Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, Alphapharm Pty Ltd, Pharmaceutical Associates, Inc., Cipla Australia Pty Ltd +1 more
Registrations on file	23
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

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

4 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

Union Quimico Farmaceutica SA (Uquifa Sa)Dr Reddys Laboratories LTDOrchev Pharma PVT LTDSms Pharmaceuticals LTD

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

Recalls official enforcement reports

🇺🇸

Ranitidine

Direct Rx · Jan 2020

Class IIdetails ↗

🇺🇸

Ranitidine

Direct Rx · Jan 2020

Class IIdetails ↗

🇺🇸

Ranitidine

H J Harkins Company Inc dba Pharma Pac · Jan 2020

Class IIdetails ↗

🇺🇸

Ranitidine

AAA Pharmaceutical, Inc. · Dec 2019

Class IIdetails ↗

🇺🇸

Ranitidine

AAA Pharmaceutical, Inc. · Dec 2019

Class IIdetails ↗

🇺🇸

RANITIDINE

Granules India Limited · Dec 2019

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders23 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
Suspended from ARTG - ZOLISON FORTE	300mg	—	🇦🇺 AU	—	Active
ZANTAC ranitidine	150 mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ZANTAC ranitidine	150mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Suspended from ARTG RANI	300mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Suspended from ARTG – RANI	300mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Suspended from ARTG – RANI	150mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Suspended from ARTG RANI	150mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
Ranitidine	15mg/mL	syrup	🇺🇸 US	Pharmaceutical Associates, Inc.	Active
Suspended from ARTG - ZANTAC ranitidine	150mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Suspended from ARTG - ZANTAC ranitidine	50mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Suspended from ARTG - ZANTAC ranitidine	300mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
ZANTAC ranitidine	300 mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Suspended from ARTG - ZANTAC	75mg	tabfc	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Suspended from ARTG - CIPLA REFLUX RELIEF ranitidine	150mg	tabfc	🇦🇺 AU	Cipla Australia Pty Ltd	Active
ZANTAC DOUBLE STRENGTH ranitidine	300mg	—	🇦🇺 AU	Aspen Pharmacare Australia 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.