Saxagliptin shortage — CA supply status & alternatives

Saxagliptin

—

🇦🇺 AUST R 157907 · AstraZeneca Pty Ltd

In supply · Australia

Apo-Saxagliptin

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$35.80DPMQ A$51.70details →

✓ 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)	Saxagliptin
Brand names	Apo-Saxagliptin
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No
Marketing-authorisation holders	AstraZeneca Pty Ltd, Mylan Pharmaceuticals Inc., DR.REDDYS LABORATORIES INC, SANDOZ CANADA INCORPORATED +3 more
Registrations on file	17
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$35.80

AEMP

Dispensed (DPMQ)

A$51.70

incl. fees

Pack

saxagliptin 2.5 mg tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$1.18

Acquisition

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

16 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

Ctx Lifesciences PVT LTDWockhardt Bio AGApitoria Pharma Private LTDMatrix Pharmacorp Private LTDAlivus Life Sciences LTDTapi Nl BV+10 more

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

Recalls official enforcement reports

🇺🇸

SAXAGLIPTIN

Glenmark Pharmaceuticals Inc., USA · Mar 2025

Class IIdetails ↗

🇺🇸

SAXAGLIPTIN

Glenmark Pharmaceuticals Inc., USA · Mar 2025

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 22 June 2026

high reported

🇨🇦 2 June 2026

high reported

🇨🇦 26 May 2026

high reported

🇨🇦 13 Apr 2026

high reported

🇨🇦 10 Mar 2026

high reported

🇨🇦 9 Mar 2026

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders17 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
ONGLYZA saxagliptin	5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Kombiglyze Xr	2.5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Kombiglyze Xr	5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
ONGLYZA saxagliptin	2.5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Qtern	5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Saxagliptin	2.5mg/1	tablet	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Saxagliptin	5mg/1	tablet	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Saxagliptin and Metformin	500; 5mg/1; mg/1	tablet	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Saxagliptin and Metformin	1000; 2.5mg/1; mg/1	tablet	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Saxagliptin and Metformin	1000; 5mg/1; mg/1	tablet	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Saxagliptin and Metformin Hydrochloride	1000; 2.5mg/1; mg/1	tablet	🇺🇸 US	DR.REDDYS LABORATORIES INC	Active
Saxagliptin and Metformin Hydrochloride	1000; 5mg/1; mg/1	tablet	🇺🇸 US	DR.REDDYS LABORATORIES INC	Active
Saxagliptin and Metformin Hydrochloride	500; 5mg/1; mg/1	tablet	🇺🇸 US	DR.REDDYS LABORATORIES INC	Active
Sandoz Saxagliptin	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Apo-Saxagliptin	—	tablet	🇨🇦 CA	APOTEX INC	Active

+2 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.