Dapagliflozin shortage — CA supply status & alternatives

Dapagliflozin

ATC A10BK01

🇦🇺 AUST R 369270 · Cipla Australia Pty Ltd

In supply · Australia

Qtern

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$36.42DPMQ A$52.35details →

✓ 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)	Dapagliflozin

ATC level 5	A10BK01

ATC level 4	A10BK

Therapeutic category	Canonical INN head (inn_resolution)

Controlled substance	No

Marketing-authorisation holders	Cipla Australia Pty Ltd, AstraZeneca Pty Ltd, A-S Medication Solutions, Prasco Laboratories +8 more

Registrations on file	20

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$36.42

AEMP

Dispensed (DPMQ)

A$52.35

incl. fees

Pack

dapagliflozin 10 mg tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£2.30

Drug Tariff

🇺🇸 US

US$0.20

Acquisition

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

47 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

Linhai Tianyu Pharmaceutical CO LTDMicro Labs LTDZaklady Farmaceutyczne Polpharma SAPorton Pharma Solutions LTDHonour Lab LTDHikal LTD+41 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders20 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
Cipla	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
DAPAGLICIP dapagliflozin	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
FOCIPRA dapagliflozin	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Sidapvia	10 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Xigduo Xr	10 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Xigduo Xr	5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
FORXIGA dapagliflozin	10 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Qtern	5 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
DAPAGLIFLOZIN	5mg/1	tablet	🇺🇸 US	A-S Medication Solutions	Active
DAPAGLIFLOZIN	10mg/1	tablet	🇺🇸 US	A-S Medication Solutions	Active
dapagliflozin and metformin hydrochloride	5; 1000mg/1; mg/1	tablet	🇺🇸 US	Prasco Laboratories	Active
dapagliflozin and metformin hydrochloride	10; 1000mg/1; mg/1	tablet	🇺🇸 US	Prasco Laboratories	Active
Dapagliflozin Viatris	—	—	🌐 EU	Viatris Limited	Active
Sandoz Dapagliflozin	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Gln-Dapagliflozin	—	tablet	🇨🇦 CA	GLENMARK PHARMACEUTICALS CANADA INC.	Active

+5 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.