Bupivacaine — supply status, manufacturers & alternatives

Bupivacaine

ATC N01BB01

🇦🇺 AUST R 292526 · Pfizer Australia Pty Ltd

In supply · Australia

ExparelBupivacaine HydrochloridePfizer BUPIVACAINE HYDROCHLORIDE 0.25% injection BPBupivacaine Hydrochloride Inj., USP 0.25%, packaged inMARCAIN 0.25% EPIDURAL INFUSION bupivacaine hydrochloride

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

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)	Bupivacaine
Brand names	Exparel, Bupivacaine Hydrochloride, Pfizer BUPIVACAINE HYDROCHLORIDE 0.25% injection BP, Bupivacaine Hydrochloride Inj., USP 0.25%, packaged in, MARCAIN 0.25% EPIDURAL INFUSION bupivacaine hydrochloride
ATC level 5	N01BB01
ATC level 4	N01BB
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
WHO Essential Medicine	Yes · 1.2. Local anaesthetics (2023)
Controlled substance	No
Marketing-authorisation holders	Pfizer Australia Pty Ltd, Boucher & Muir Pty Ltd, Aspen Pharmacare Australia Pty Ltd, PHEBRA PTY LTD +9 more
Registrations on file	25
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$0.05

Acquisition

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

Siegfried Evionnaz SACambrex Karlskoga ABDishman Carbogen Amcis LTDNortec Quimica SAJiangsu Hengrui Pharmaceuticals CO LTDMsn Life Sciences Private LTD+2 more

Manufacturing countries: Switzerland, Sweden, India, Brazil, China · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

EXPAREL

Pacira Pharmaceuticals, Inc. · Nov 2019

Class IIdetails ↗

🇺🇸

Bupivacaine

Pharmakon Pharmaceuticals, Inc. · Apr 2016

Class IIdetails ↗

🇺🇸

Bupivacaine

Abbott's Compounding Pharmacy, Inc. · Jan 2016

Class IIdetails ↗

🇺🇸

Bupivacaine

The Compounding Pharmacy of America · June 2015

Class IIdetails ↗

🇺🇸

Bupivacaine

The Compounding Pharmacy of America · June 2015

Class IIdetails ↗

🇺🇸

Bupivacaine

Zions RX Formulations Services LLC dba RX Formuations Serv. · Dec 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders25 registrations · 13 MA holders

Product	Strength	Form	Market	MA holder	Status
BUPIVADREN Bupivacaine 0.25% w/v with Adrenaline 1:	0.25%	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
PFIZER BUPIVACAINE 0.5% w/v WITH ADRENALINE 1:	0.5%	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
SPINAL HEAVY BNM bupivacaine hydrochloride	20 mg	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active
Marcain 0.125% With Fentanyl	0.125%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Bupivacaine 0.5% With Adrenaline 1:	0.5%	—	🇦🇺 AU	PHEBRA PTY LTD	Active
Bupivacaine 0.25% With Adrenaline 1:	0.25%	—	🇦🇺 AU	PHEBRA PTY LTD	Active
Bupivacaine-Claris	2.5MG	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
Bupivacaine-Claris	5MG	injection	🇬🇧 GB	BAXTER HEALTHCARE LIMITED	Active
BAXTER bupivacaine hydrochloride monohydrate	50 mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
BAXTER bupivacaine hydrochloride monohydrate	100 mg	—	🇦🇺 AU	Baxter Healthcare Pty Ltd	Active
Levobupivacaine	2.5 MG	injection	🇬🇧 GB	ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA	Active
Levobupivacaine	5 MG	injection	🇬🇧 GB	ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA	Active
Levobupivacaine	7.5 MG	injection	🇬🇧 GB	ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA	Active
Levobupivacaine	0.625 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active
Levobupivacaine	1.25 MG	solution	🇬🇧 GB	FRESENIUS KABI LIMITED	Active

+10 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.