Insulin aspart shortage — US supply status & alternatives

Insulin aspart

ATC A10AB05 · Rapid-acting insulin analogue

🇦🇺 AUST R 143166 · Novo Nordisk Pharmaceuticals Pty Ltd

In shortage · Australia

In declared shortage · 🇦🇺 Australia & also short in🇺🇸 US🇨🇦 CA🇩🇪 DE🇪🇸 ES🌐 EU🇧🇪 BE🇳🇴 NO

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AUAEMP

Product attributes reference data we hold

Active ingredient (INN)	Insulin aspart
Brand names	Fiasp, NovoLog, NovoRapid
ATC level 5	A10AB05
ATC level 4	A10AB
Drug class	Rapid-acting insulin analogue
Therapeutic category	Endocrine/Metabolic
Strength	100 units/ml
Dosage form	solution for injection
Route of administration	subcutaneous · intravenous
Controlled substance	No
Marketing-authorisation holders	Novo Nordisk Pharmaceuticals Pty Ltd, A-S Medication Solutions, REMEDYREPACK INC., Sanofi Winthrop Industrie +1 more
Registrations on file	14
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$16.33

AEMP

Dispensed (DPMQ)

A$99.49

incl. fees

Pack

insulin aspart 100 units/mL injection, 1 x 10 mL vial

solution for injection

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$6.95

Acquisition

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

5 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

Amphastar Nanjing Pharmaceuticals INCNingbo Kunpeng Biotech CO LTDYifan Pharmaceutical (Shanghai) CO LTDHangzhou Zhongmei Huadong Pharmaceutical CO LTDNanjing Cellnuo Biopharmaceutical CO LTD

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

Shortage status by regulator official notices

🇺🇸

United States

FDA · 1h ago

Critical

🇨🇦

Canada

HC · just now

High

🇦🇺

Australia

TGA · 1h ago

High

🇩🇪

Germany

BfArM · 1d ago

High

🌐

EMA · 1d ago

High

🇪🇸

Spain

AEMPS · 1mo ago

High

🇳🇴

Norway

NOMA · 3d ago

Medium

🇳🇿

New Zealand

Pharmac · 1mo ago

Resolved

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA

verified 1h ago

verify ↗

🇦🇺

TGA

verified 1h ago

verify ↗

🇩🇪

BfArM

verified 1d ago

verify ↗

🌐

EMA

verified 1d ago

verify ↗

🇳🇴

NOMA

verified 3d ago

verify ↗

🇪🇸

AEMPS

verified 1mo ago

verify ↗

🇳🇿

Pharmac

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders14 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
Novomix	3mL	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
FIASP FLEXTOUCH insulin aspart	100 units	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
NOVORAPID insulin aspart 100U/mL injection multidose	—	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
NOVORAPID PENFILL insulin aspart 300U/	3mL	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
NOVORAPID FLEXPEN insulin aspart 300U/	3mL	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
NOVORAPID FLEXTOUCH insulin aspart 300U /	3mL	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
FIASP insulin aspart	100 units	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
FIASP PENFILL insulin aspart	100 units	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
Ryzodeg	70%	—	🇦🇺 AU	Novo Nordisk Pharmaceuticals Pty Ltd	Active
.Insulin Aspart Protamine and	100[iU]/mL	injection	🇺🇸 US	A-S Medication Solutions	Active
Insulin Aspart	100[iU]/mL	injection	🇺🇸 US	A-S Medication Solutions	Active
Protamine and	100[iU]/mL	injection	🇺🇸 US	REMEDYREPACK INC.	Active
Insulin aspart Sanofi	—	—	🌐 EU	Sanofi Winthrop Industrie	Active
Insulin Aspart Injection	—	—	🌐 EU	Masuu Pharma Europe Limited	Application withdrawn

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.