Glycopyrrolate shortage — US supply status & alternatives

Glycopyrrolate

—

🇦🇺 AUST R 370932 · KSJ Pharmatech

In supply · Australia

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

In supply in Australia

Reading today’s signals…

✓ 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)	Glycopyrrolate
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No

Marketing-authorisation holders	KSJ Pharmatech, AFT Pharmaceuticals Pty Ltd, MERCURY PHARMACEUTICALS LIMITED, HIKMA PHARMACEUTICALS USA INC. +3 more

Registrations on file	11

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

🇺🇸 US

US$0.15

Acquisition

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

15 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

Hikma Pharmaceuticals LLCViyash Life Sciences Private LTDAmsa SPAPcasAkshat Pharma Private LTDHarman Finochem LTD+9 more

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

Recalls official enforcement reports

🇺🇸

GLYCOPYRROLATE

NOVADOZ PHARMACEUTICALS LLC · Dec 2025

Class IIIdetails ↗

🇺🇸

Glycopyrrolate

Denver Solutions, LLC DBA Leiters Health · Mar 2025

Class IIdetails ↗

🇺🇸

Glycopyrrolate

Central Admixture Pharmacy Services, Inc. · July 2023

Class IIdetails ↗

🇺🇸

GLYCOPYRROLATE

HF Acquisition Co LLC · June 2023

Class IIIdetails ↗

🇺🇸

GLYCOPYRROLATE

Aurolife Pharma, LLC · May 2023

Class IIIdetails ↗

🇺🇸

GLYCOPYRROLATE

Accord Healthcare, Inc. · Feb 2023

Class IIdetails ↗

Verified timeline regulator events

🇨🇦 1 May 2026

high reported

🇨🇦 26 Mar 2026

high reported

🇨🇦 23 Mar 2026

high reported

🇨🇦 12 Mar 2026

high reported

🇨🇦 2 Feb 2026

high reported

🇺🇸 15 Dec 2025

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders11 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
Glneo	2.5 g	—	🇦🇺 AU	KSJ Pharmatech	Active
Glyconeo	2.5 g	—	🇦🇺 AU	KSJ Pharmatech	Active
GLYCOPYRRONIUM-AFT glycopyrronium bromide	200 microgram	—	🇦🇺 AU	AFT Pharmaceuticals Pty Ltd	Active
GLYCOPYRROLATE 200 MICROGRAMS/ML SOLUTION FOR INJECTION	200 MICROGRAM	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Glycopyrrolate-Neostigmine	—	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Glycopyrrolate	.2mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
ROBINUL glycopyrronium bromide	0.2mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Accord	0.6 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
Accord	0.2 mg	—	🇦🇺 AU	Accord Healthcare Pty Ltd	Active
ROBINUL glycopyrronium bromide	0.4mg	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
NOVISTIG glycopyrronium bromide /neostigmine methylsulfate	0.5 mg	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active

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.