Ropivacaine Hydrochloride shortage — BE supply status & alternatives

Ropivacaine Hydrochloride

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🇦🇺 AUST R 186569 · Boucher & Muir Pty Ltd

In supply · Australia

Naropin

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

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)	Ropivacaine Hydrochloride

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

Controlled substance	No

Marketing-authorisation holders	Boucher & Muir Pty Ltd, B BRAUN MELSUNGEN AG, SANDOZ LIMITED, HIKMA PHARMACEUTICALS USA INC. +1 more

Registrations on file	15

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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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

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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

10 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

Excella GMBH And CO KgFine Chemicals Corp Pty LTDJubilant Biosys LTDShandong Anhong Pharmaceutical CO LTDDishman Carbogen Amcis LTDNavinta LLC+4 more

Manufacturing countries: Germany, South Africa, India, China, United States, Italy, Spain · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Mar 2025

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA · 3h ago

High

🇧🇪

FAMHP · 12h ago

High

🇨🇦

Canada

HC · 3h ago

Medium

Recalls official enforcement reports

🇺🇸

ROPIVACAINE HYDROCHLORIDE

Amneal Pharmaceuticals, LLC · Apr 2025

Class Idetails ↗

Verified timeline regulator events

🇧🇪 26 June 2026

medium reported

🇧🇪 7 May 2026

medium reported

🇧🇪 20 Apr 2026

high reported

🇧🇪 9 Apr 2026

high reported

🇧🇪 13 Mar 2026

medium reported

🇧🇪 11 Feb 2026

high reported

Sources official regulators

🇨🇦

verified 3h ago

verify ↗

🇺🇸

FDA

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 12h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders15 registrations · 5 MA holders

Product	Strength	Form	Market	MA holder	Status
ROPIBAM 0.75% Ropivacaine hydrochloride	0.75%	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active
ROPIBAM 0.2% Ropivacaine hydrochloride	0.2%	—	🇦🇺 AU	Boucher & Muir Pty Ltd	Active
ROPIVACAINE HYDROCHLORIDE 2 MG/ML SOLUTION FOR INJECTION/INFUSION	2 MG	injection	🇬🇧 GB	B BRAUN MELSUNGEN AG	Active
ROPIVACAINE HYDROCHLORIDE 2MG/ML SOLUTION FOR INJECTION	2MG	injection	🇬🇧 GB	SANDOZ LIMITED	Active
ROPIVACAINE HYDROCHLORIDE 7.5MG/ML SOLUTION FOR INJECTION	7.5MG	injection	🇬🇧 GB	SANDOZ LIMITED	Active
ROPIVACAINE HYDROCHLORIDE 10MG/ML SOLUTION FOR INJECTION	10MG	injection	🇬🇧 GB	SANDOZ LIMITED	Active
Ropivacaine Hydrochloride	2mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Ropivacaine Hydrochloride	5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Ropivacaine Hydrochloride	7.5mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
Ropivacaine Hydrochloride	10mg/mL	injection	🇺🇸 US	HIKMA PHARMACEUTICALS USA INC.	Active
NAROPIN 0.2% ropivacaine hydrochloride	0.2%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
NAROPIN 1% ropivacaine hydrochloride	1%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
NAROPIN 0.75% ropivacaine hydrochloride	0.75%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
NAROPIN 0.5% ropivacaine hydrochloride	0.5%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active
Naropin 0.2% With Fentanyl	0.2%	—	🇦🇺 AU	Aspen Pharmacare Australia Pty Ltd	Active

Mederti Drug Report

Generated 5 July 2026 · Australia market · 3 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.