Oxytocin shortage — US supply status & alternatives

Oxytocin

—

🇦🇺 AUST R 164131 · Mylan Health Pty Ltd

In supply · Australia

SYNTOCINON oxytocin

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

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

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)

Brand names	SYNTOCINON oxytocin

Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Mylan Health Pty Ltd, HAMELN PHARMA LTD, ESTEVE PHARMACEUTICALS LTD, EVER NEURO PHARMA GMBH +5 more

Registrations on file	22

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

€2.78

Retail price

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

◷

~4 months

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

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

8 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✓ 1 WHO-prequalified

Aspen Oss BVHarbin Jixianglong Biotech CO LTDPiramal Pharma LimitedJoint Stock CO GrindeksHemmo Pharmaceuticals PVT LTDHybio Pharmaceutical CO LTD+2 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Oct 1986

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 1mo ago

Critical

🇨🇦

Canada

HC · just now

High

🇩🇪

Germany

BfArM · 1d ago

High

🇦🇺

Australia

TGA · 2mo ago

Resolved

Recalls official enforcement reports

🇺🇸

Oxytocin

IntegraDose Compounding Services LLC · Sept 2025

Class Idetails ↗

🇺🇸

Oxytocin

Fresenius Kabi Compounding, LLC · Sept 2024

Class IIdetails ↗

🇺🇸

Oxytocin

Central Admixture Pharmacy Services, Inc. · Aug 2023

Class IIdetails ↗

🇺🇸

Oxytocin

Central Admixture Pharmacy Services, Inc. · Aug 2023

Class IIdetails ↗

🇺🇸

Oxytocin

Central Admixture Pharmacy Services, Inc. · Aug 2023

Class IIdetails ↗

🇺🇸

Oxytocin

Central Admixture Pharmacy Services, Inc. · July 2023

Class IIdetails ↗

Verified timeline regulator events

🇩🇪 8 June 2026

high reported

🇨🇦 14 May 2026

high reported

🇨🇦 2 Mar 2026

high reported

🇩🇪 16 Oct 2025

medium reported

🇺🇸 16 Sept 2025

critical reported

🇺🇸 30 July 2025

high reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇩🇪

BfArM

verified 1d ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

🇦🇺

TGA

verified 2mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders22 registrations · 9 MA holders

Product	Strength	Form	Market	MA holder	Status
VIATOCINON oxytocin	10 IU	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
VIATOCINON oxytocin	5 IU	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
SYNTOCINON oxytocin	10 IU	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
SYNTOCINON oxytocin	5 IU	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
OXYTOCIN 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION	10 IU	solution	🇬🇧 GB	HAMELN PHARMA LTD	Active
OXYTOCIN 10 IU/ML SOLUTION FOR INFUSION	10 IU	solution	🇬🇧 GB	ESTEVE PHARMACEUTICALS LTD	Active
OXYTOCIN 5IU SOLUTION FOR INJECTION	5IU	injection	🇬🇧 GB	EVER NEURO PHARMA GMBH	Active
OXYTOCIN 10IU SOLUTION FOR INJECTION	10IU	injection	🇬🇧 GB	EVER NEURO PHARMA GMBH	Active
Oxytocin Panpharma	5 IU	solution	🇬🇧 GB	PANPHARMA	Active
Oxytocin Panpharma	10 IU	solution	🇬🇧 GB	PANPHARMA	Active
Oxytocin	10[USP'U]/mL	injection	🇺🇸 US	West-Ward Pharmaceuticals Corp	Active
SYNTOCINON oxytocin	40 IU	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
SYNTOMETRINE oxytocin / ergometrine maleate	1mL	—	🇦🇺 AU	PHEBRA PTY LTD	Active
RYMPA INJECTION oxytocin / ergometrine maleate	1mL	—	🇦🇺 AU	PHEBRA PTY LTD	Active
OXYTOCIN GH Solution for	5 IU	—	🇦🇺 AU	Generic Health Pty Ltd	Active

+7 more registrations on file

Mederti Drug Report

Generated 2 July 2026 · Australia market · 4 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.