Dobutamine Hydrochloride shortage — US supply status & alternatives

Dobutamine Hydrochloride

ATC C01CA07

🇦🇺 AUST R 14628

In supply · Australia

Dobutamine In Dextrose

In supply · 🇦🇺 Australia · short in🇺🇸 US🇫🇷 FR

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)	Dobutamine Hydrochloride
Brand names	Dobutamine In Dextrose

ATC level 5	C01CA07

ATC level 4	C01CA

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

Controlled substance	No

Marketing-authorisation holders	ENNOGEN PHARMA LIMITED, BAXTER HEALTHCARE CORPORATION, HF Acquisition Co LLC, DBA HealthFirst, NOVOPHARM LIMITED

Registrations on file	7

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.

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.

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

5 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.

Moderate concentration risk

Chemwerth INCRecordati Industria Chimica E Farmaceutica SPASiegfried Pharmachemikalien Minden GMBHHainan Poly Pharm CO LTDAragen Life Sciences LTD

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

Verified timeline regulator events

🇫🇷 4 May 2026

medium reported

🇺🇸 27 Aug 2025

medium reported

🇺🇸 27 Aug 2025

medium reported

🇺🇸 28 May 2025

high reported

🇺🇸 6 Nov 2017

medium reported

🇺🇸 6 Nov 2017

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders7 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Sterile Dobutamine Hydrochloride	250MG	solution	🇬🇧 GB	ENNOGEN PHARMA LIMITED	Active
DOBUTREX dobutamine hydrochloride	250mg	—	🇦🇺 AU	—	Active
Dobutamine Hydrochloride in Dextrose	100mg/100mL	injection	🇺🇸 US	BAXTER HEALTHCARE CORPORATION	Active
Dobutamine Hydrochloride in Dextrose	200mg/100mL	injection	🇺🇸 US	BAXTER HEALTHCARE CORPORATION	Active
Dobutamine Hydrochloride in Dextrose	400mg/100mL	injection	🇺🇸 US	BAXTER HEALTHCARE CORPORATION	Active
DOBUTAMINE HYDROCHLORIDE	100mg/100mL	injection	🇺🇸 US	HF Acquisition Co LLC, DBA HealthFirst	Active
Dobutamine Hydrochloride Injection-	12.5MG	liquid	🇨🇦 CA	NOVOPHARM LIMITED	Dormant

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.