Tramadol Hydrochloride shortage — US supply status & alternatives

Tramadol Hydrochloride

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🇦🇺 AUST R 308528

In supply · Australia

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

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

Controlled substance
Active ingredient (INN)	Tramadol Hydrochloride
Therapeutic category	Auto-created by FDA Drug Enforcement — Foreign Manufacturer Recalls scraper

Marketing-authorisation holders	Ipca Pharma (Australia) Pty Ltd, Southern Cross Pharma Pty Ltd, ACCORD-UK LIMITED, HAMELN PHARMA LTD +7 more

Registrations on file	24

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)

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Pack

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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.

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

Sun Pharmaceutical Industries LTDEmnar Pharma Private LTDWavelength Enterprises LTDZydus Lifesciences LTDWanbury LTDJubilant Biosys LTD+9 more

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

Recalls official enforcement reports

🇺🇸

TRAMADOL HYDROCHLORIDE

Amneal Pharmaceuticals, LLC · Mar 2026

Class IIdetails ↗

🇺🇸

TRAMADOL HYDROCHLORIDE

Rubicon Research Private Limited · Apr 2024

Class IIdetails ↗

🇺🇸

Tramadol Hydrochloride

Lake Erie Medical & Surgical Supply Inc · Mar 2018

Class IIIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders24 registrations · 11 MA holders

Product	Strength	Form	Market	MA holder	Status
NOUMED TRAMADOL SR tramadol hydrochloride	150 mg	—	🇦🇺 AU	—	Active
IPCA-TRAMADOL tramadol hydrochloride	50mg	—	🇦🇺 AU	Ipca Pharma (Australia) Pty Ltd	Active
IPTRAMOL tramadol hydrochloride	50mg	—	🇦🇺 AU	—	Active
TRAMADOL-WGR SR tramadol hydrochloride	100 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
TRAMADOL-WGR SR tramadol hydrochloride	150 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
TRAMADOL-WGR SR tramadol hydrochloride	200 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active
TRAMADOL HYDROCHLORIDE 50MG CAPSULES	50MG	capsule	🇬🇧 GB	ACCORD-UK LIMITED	Active
TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION	50 MG	injection	🇬🇧 GB	HAMELN PHARMA LTD	Active
Tramadol Hydrochloride Krka	100 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
Tramadol Hydrochloride Krka	150 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
Tramadol Hydrochloride Krka	200 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
Tramadol Hydrochloride/Paracetamol	37.5 MG	tablet	🇬🇧 GB	KRKA, TOVARNA ZDRAVIL, D.D., NOVO MESTO	Active
Tramadol Hydrochloride/ Paracetamol	37.5MG	tablet	🇬🇧 GB	STRANDHAVEN LIMITED	Active
TRAMADOL HYDROCHLORIDE 50MG CAPSULES, HARD	50MG	capsule	🇬🇧 GB	STRANDHAVEN LIMITED	Active
Tramadol Hydrochloride And Paracetamol	37.5 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active

+9 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.