Paracetamol shortage — AU supply status & alternatives

Paracetamol

ATC N02BE01 · Non-opioid analgesic/antipyretic

🇦🇺 AUST R 306717

In shortage · Australia

WHO Essential Medicine

TempraPanadol PanamaxTylenol

In declared shortage · 🇦🇺 Australia & also short in🇺🇸 US🇪🇸 ES🇧🇪 BE🇬🇷 GR🇮🇪 IE🇮🇳 IN🌐 MY🇳🇱 NL

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AU

Product attributes reference data we hold

Active ingredient (INN)	Paracetamol
Brand names	Tempra, Panadol, Panamax, Tylenol
ATC level 5	N02BE01
ATC level 4	N02BE
Drug class	Non-opioid analgesic/antipyretic
Therapeutic category	Analgesic
Strength	500mg · 1000mg · 10mg/ml IV · 120mg/5ml oral
Dosage form	tablet · capsule · oral solution · suppository · solution for infusion
Route of administration	oral · rectal · intravenous
WHO Essential Medicine	Yes · 2.1. Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) (2023)
Controlled substance	No
Marketing-authorisation holders	Sanofi-Aventis Australia Pty Ltd, GlaxoSmithKline Consumer Healthcare Australia Pty Ltd, iNova Pharmaceuticals Australia Pty Ltd, Ipca Pharma (Australia) Pty Ltd +4 more
Registrations on file	29
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

1 API manufacturer

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.

Very high concentration risk

Specgx LLC

Manufacturing countries: United States · Source: FDA List of Drug Master Files

Shortage status by regulator official notices

🇦🇺

Australia

TGA · 3h ago

Critical

🇺🇸

United States

FDA MedWatch · 1mo ago

Critical

🇬🇧

United Kingdom

MHRA · 1mo ago

Resolved

🌐

NPRA · 3h ago

Medium

🇬🇷

EOF · 4h ago

Medium

🇧🇪

FAMHP · 4h ago

Medium

🇳🇴

Norway

NOMA · 3d ago

Resolved

🇮🇳

CDSCO · 28d ago

Medium

Sources official regulators

🇦🇺

TGA

verified 3h ago

verify ↗

🌐

NPRA

verified 3h ago

verify ↗

🇬🇷

EOF

verified 4h ago

verify ↗

🇧🇪

FAMHP

verified 4h ago

verify ↗

🇳🇴

NOMA

verified 3d ago

verify ↗

🇮🇳

CDSCO

verified 28d ago

verify ↗

🇺🇸

ANSM Ruptures

verified 1mo ago

verify ↗

🇬🇧

MHRA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders29 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
Priceline Pharmacy Paracetamol Colour Free Suspension 1-	24mg	—	🇦🇺 AU	—	Active
Apx-Paracetamol/Codeine	500 mg	—	🇦🇺 AU	Sanofi-Aventis Australia Pty Ltd	Active
Panadol Suppositories paracetamol	500 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
Panadol Children Suppositories	125 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
Panadol Children Suppositories	250 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
Nyal	500 mg	—	🇦🇺 AU	iNova Pharmaceuticals Australia Pty Ltd	Active
SPIRO LIFECARE IBUPROFEN + PARACETAMOL tablet blister pack	—	—	🇦🇺 AU	—	Active
Pharmacy Own Paracetamol	500 mg	—	🇦🇺 AU	—	Active
PANADOL RAPID paracetamol	500mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
PANAMAX paracetamol	500mg	—	🇦🇺 AU	Sanofi-Aventis Australia Pty Ltd	Active
Panadol Children 5 -	48 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
PANADOL RAPID SOLUBLE paracetamol	500mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
Cipla Paracetamol	500mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
PHARMACY OWN IBUPROFEN + PARACETAMOL liquid capsule blister pack	—	—	🇦🇺 AU	—	Active
Pharmacy Health Paracetamol & Ibuprofen Soft Gels	500 mg	—	🇦🇺 AU	—	Active

+14 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.