Risedronate Sodium shortage — CA supply status & alternatives

Risedronate Sodium

—

🇦🇺 AUST R 74135

In supply · Australia

Actonel

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$18.99DPMQ A$53.98details →

✓ 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)	Risedronate Sodium
Brand names	Actonel
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, SANDOZ LIMITED, WAYMADE PLC, PHARMATHEN SA +4 more
Registrations on file	16
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$18.99

AEMP

Dispensed (DPMQ)

A$53.98

incl. fees

Pack

risedronate sodium 35 mg enteric tablet, 4

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£0.96

Drug Tariff

Substitution pathways 🇦🇺 Australia · TGA

—

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

12 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

Synthimed Labs Private LTDCipla LTDApitoria Pharma Private LTDTapi Nl BVJubilant Biosys LTDMatrix Pharmacorp Private LTD+6 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Nov 2016

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

ANSM Ruptures · 3mo ago

High

🇨🇦

Canada

HC · 3h ago

Medium

🇮🇹

Italy

AIFA · 1d ago

Medium

Recalls official enforcement reports

🇺🇸

RISEDRONATE SODIUM

Macleods Pharma Usa Inc · Mar 2022

Class IIIdetails ↗

Verified timeline regulator events

🇨🇦 6 May 2026

medium reported

🇨🇦 30 Mar 2026

medium reported

🇨🇦 4 Mar 2026

medium reported

🇮🇹 20 Jan 2026

medium reported

🇨🇦 1 Jan 2026

medium reported

🇮🇹 12 Feb 2024

Shortage resolved

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇮🇹

AIFA

verified 1d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 3mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders16 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
RISEDRONATE SODIUM 5MG FILM-COATED TABLETS	5MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS	30 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
RISEDRONATE SODIUM 35MG FILM-COATED TABLETS	35MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
RISEDRONATE SODIUM 35 MG FILM-COATED TABLETS	35 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
Risedronate Sodium And Calcium / Cholecalciferol	35 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
RISEDRONATE SODIUM 5 MG FILM-COATED TABLETS	5 MG	tablet	🇬🇧 GB	WAYMADE PLC	Active
RISEDRONATE SODIUM 30MG FILM-COATED TABLETS	30MG	tablet	🇬🇧 GB	PHARMATHEN SA	Active
Risedronate Sodium Accord Once A Week	35 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
RISEDRONATE SODIUM 35 MG GASTRO-RESISTANT TABLETS	35 MG	tablet	🇬🇧 GB	THERAMEX HQ UK LIMITED	Active
Risedronate Sodium	35mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Risedronate Sodium	5mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Risedronate Sodium	30mg/1	tablet	🇺🇸 US	TEVA PHARMACEUTICALS USA, INC.	Active
Actonel	5mg	—	🇦🇺 AU	—	Active
Actonel	30mg	—	🇦🇺 AU	—	Active
ACTONEL ONCE-A-MONTH risedronate sodium	150 mg	—	🇦🇺 AU	—	Active

+1 more registration on file

Mederti Drug Report

Generated 4 July 2026 · Australia market · 3 regulatory sources

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.