Atropine — supply status, manufacturers & alternatives

Atropine

ATC A03BA01

🇦🇺 AUST R 19648 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

Atropine SulfateAtropine sulfate FGKAtropine 0,3%, collyre –Atropine Sulfate Injection, USPAtropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a)

In supply · 🇦🇺 Australia · short in🇳🇿 NZ

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Product attributes reference data we hold

Active ingredient (INN)	Atropine
Brand names	Atropine Sulfate, Atropine sulfate FGK, Atropine 0,3%, collyre –, Atropine Sulfate Injection, USP, Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a)
ATC level 5	A03BA01
ATC level 4	A03BA
Therapeutic category	Auto-created by EMA — Withdrawn / Refused / Revoked Medicines scraper
WHO Essential Medicine	Yes · 1.3. Preoperative medication and sedation for short-term procedures (2023)
Controlled substance	No
Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, Juno Pharmaceuticals Pty Ltd, ACCORD-UK LIMITED, MARTINDALE PHARMACEUTICALS LIMITED +12 more
Registrations on file	27
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇫🇷 FR

€2.47

Retail price

🇺🇸 US

US$4.35

Acquisition

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

Rolabo Outsourcing Sl

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

Recalls official enforcement reports

🇳🇿

Atropine

Mar 2025

Class Idetails ↗

🇺🇸

Atropine

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy · Apr 2019

Class IIdetails ↗

🇺🇸

Atropine

Ranier's Compounding Laboratory · July 2018

Class IIdetails ↗

🇺🇸

Atropine

Walter's Pharmacy · Feb 2016

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 16 MA holders

Product	Strength	Form	Market	MA holder	Status
ATROPT 1% atropine sulfate monohydrate	1%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
EIKANCE 0.01% atropine sulfate monohydrate	0.01%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
JUNO atropine sulfate monohydrate	400 microgram	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
JUNO atropine sulfate monohydrate	1.2mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
JUNO atropine sulfate monohydrate	600 microgram	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
Atropine Sulfate	0.1 MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active
Atropine Eye Drops 1.0% W/V	1.0%	drops	🇬🇧 GB	MARTINDALE PHARMACEUTICALS LIMITED	Active
Atropine Sulfate	600 MICROGRAM	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
Atropine Sulphate Injection Bp	—	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
Atropine Sulphate Injection Bp	600MCG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Atropine Sulphate Injection Bp	1MG	injection	🇬🇧 GB	MACARTHYS LABORATORIES LIMITED	Active
Minims Atropine Sulphate 1%	1%	minims	🇬🇧 GB	BAUSCH & LOMB U.K. LIMITED	Active
Atropine Sulfate	0.5 MG	injection	🇬🇧 GB	LABORATOIRE AGUETTANT	Active
Atropine Sulfate	1MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
Atropine Sulfate	600MCG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active

+12 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.