Atropine Sulfate shortage — US supply status & alternatives

Atropine Sulfate

ATC A03BA01

🇦🇺 AUST R 19648 · Aspen Pharmacare Australia Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇫🇷 FR🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$2.50DPMQ A$17.10details →

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Atropine Sulfate

ATC level 5	A03BA01

ATC level 4	A03BA

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Aspen Pharmacare Australia Pty Ltd, Juno Pharmaceuticals Pty Ltd, ACCORD-UK LIMITED, HAMELN PHARMA LTD +11 more

Registrations on file	30

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$2.50

AEMP

Dispensed (DPMQ)

A$17.10

incl. fees

Pack

diphenoxylate hydrochloride 2.5 mg + atropine sulfate monohydrate 25 microgram tablet, 20

Source: PBSEffective July 2026 · AUD

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

How long have past shortages lasted? from 1 resolved event

◷

~5 months

Historical pattern from resolved shortage records — not a prediction of this event.

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

12 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

Curia Wisconsin INCHubei Biocause Heilen Pharmaceutical CO LTDRolabo Outsourcing SlScl Lifesciences LTDResonance Laboratories PVT LTDMinsheng Group Shaoxing Pharmaceutical CO LTD+6 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

July 2024

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA · 7h ago

Critical

🇨🇦

Canada

HC · 3h ago

Medium

🇫🇷

France

ANSM · 23h ago

Medium

🇧🇪

FAMHP · 1d ago

Medium

Recalls official enforcement reports

🇺🇸

ATROPINE SULFATE

Pfizer Inc. · Dec 2023

Class Idetails ↗

🇺🇸

ATROPINE SULFATE

Accord Healthcare, Inc. · July 2023

Class IIdetails ↗

🇺🇸

Atropine Sulfate

Pharmacy Innovations · Dec 2022

Class IIdetails ↗

🇺🇸

ISOPTO ATROPINE

Mckesson Medical-Surgical Inc. Corporate Office · Apr 2022

Class IIdetails ↗

🇺🇸

Atropine Sulfate

Key Pharmacy and Compounding Center · Apr 2017

Class IIdetails ↗

🇺🇸

Atropine Sulfate

Key Pharmacy and Compounding Center · Apr 2017

Class IIdetails ↗

Verified timeline regulator events

🇧🇪 10 June 2026

medium reported

🇫🇷 6 Jan 2026

Shortage resolved

🇺🇸 7 Nov 2025

critical reported

🇺🇸 7 Nov 2025

critical reported

🇫🇷 16 Oct 2024

medium reported

🇫🇷 18 July 2024

medium reported

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇺🇸

FDA

verified 7h ago

verify ↗

🇫🇷

ANSM

verified 23h ago

verify ↗

🇺🇸

FDA MedWatch

verified 1d ago

verify ↗

🇧🇪

FAMHP

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 15 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
ATROPINE JUNO atropine sulfate monohydrate	400 microgram	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
ATROPINE JUNO atropine sulfate monohydrate	1.2mg	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
ATROPINE JUNO atropine sulfate monohydrate	600 microgram	—	🇦🇺 AU	Juno Pharmaceuticals Pty Ltd	Active
ATROPINE SULFATE 0.1 MG/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	0.1 MG	injection	🇬🇧 GB	ACCORD-UK LIMITED	Active
ATROPINE SULFATE 600 MICROGRAMS/ML SOLUTION FOR INJECTION	600 MICROGRAM	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
ATROPINE SULFATE 0.5 MG/5 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	0.5 MG	injection	🇬🇧 GB	LABORATOIRE AGUETTANT	Active
ATROPINE SULFATE 1MG IN 5ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE.	1MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
ATROPINE SULFATE INJECTION 600MCG IN 1 ML	600MCG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
ATROPINE SULFATE 3MG IN 10ML SOLUTION FOR INJECTION IN PRE-FILLED	3MG	injection	🇬🇧 GB	AURUM PHARMACEUTICALS LIMITED	Active
ATROPINE SULFATE 1 MG/5 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	1 MG	injection	🇬🇧 GB	LABORATOIRE AGUETTANT	Active
ATROPINE SULFATE 3 MG/10 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	3 MG	injection	🇬🇧 GB	LABORATOIRE AGUETTANT	Active
ATROPINE SULFATE 600 MICROGRAMS TABLETS	600 MICROGRAM	tablet	🇬🇧 GB	WOCKHARDT UK LIMITED	Active
Atropine Sulfate 1.0% W/V Eye Drops	1.0%	solution	🇬🇧 GB	BLUMONT PHARMA LIMITED	Active

+15 more registrations on file

Mederti Drug Report

Generated 6 July 2026 · Australia market · 5 regulatory sources

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.