Is Carglumic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Carglumic acid, including Aminglu (200 mg, Dispersible tablet, SAR 11540.75); CARBAGLU 200MG DISPERSIBLE TABLETS (200 mg, Dispersible tablet, SAR 1539.70); Carglumic Acid Waymade (200 mg, Dispersible tablet, SAR 943.05); Ucedane (200 mg, Dispersible tablet, SAR 10778.45).

Is Carglumic acid approved by the US FDA?

Drugs@FDA lists 3 application product lines for Carglumic acid, including CARBAGLU (Prescription); CARGLUMIC ACID (Prescription); CARGLUMIC ACID (Prescription).

Is Carglumic acid authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Carglumic acid: Carbaglu, Ucedane.

Are there safety signals or safety updates for Carglumic acid?

US FDA: 1 entry (latest 2024-01-19).

Active substance

Carglumic acid

SFDA 8
US FDA 3
EMA 2
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Aminglu	200 mg	Dispersible tablet · Oral use	60 Blister	SAR 11540.75	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CARBAGLU 200MG DISPERSIBLE TABLETS	200 mg	Dispersible tablet · Oral use	5 Bottle	SAR 1539.70	NCE · Prescription	Recordati Rare Diseases	Valid
CARBAGLU 200MG DISPERSIBLE TABLETS	200 mg	Dispersible tablet · Oral use	60 Bottle	SAR 17563.05	NCE · Prescription	Recordati Rare Diseases	Valid
Carglumic Acid Waymade	200 mg	Dispersible tablet · Oral use	5 Bottle	SAR 943.05	NCE · Prescription	Waymade Plc UK	Valid
Carglumic Acid Waymade	200 mg	Dispersible tablet · Oral use	60 Bottle	SAR 11316.45	NCE · Prescription	Waymade Plc UK	Valid
Ucedane	200 mg	Dispersible tablet · Oral use	60 Blister	SAR 10778.45	Generic · Prescription	Eurocept International BV	Valid
Ucedane	200 mg	Dispersible tablet · Oral use	12 Blister	SAR 2155.65	Generic · Prescription	Eurocept International BV	Valid
CARBAGLU 200MG DISPERSIBLE TABLETS	200 mg	Dispersible tablet · Oral use	15 Bottle	SAR 4619.15	NCE · Prescription	Recordati Rare Diseases	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CARBAGLU	200MG	tablet, for suspension · oral	RECORDATI RARE	Prescription	18 Mar 2010
CARGLUMIC ACID	200MG	tablet, for suspension · oral	NOVITIUM PHARMA	Prescription	13 Oct 2021
CARGLUMIC ACID	200MG	tablet, for suspension · oral	NAVINTA LLC	Prescription	22 Jun 2022

EMA European Union — centrally authorised medicines

Carbaglu Tour Hekla · Authorised · authorised 24 Jan 2003 · ATC A16AA05

Therapeutic indication (EMA)

Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia.

Ucedane Eurocept International BV · Authorised · authorised 23 Jun 2017 · ATC A16AA05

Therapeutic indication (EMA)

Ucedane is indicated in treatment of: hyperammonaemia due to N-acetylglutamate synthase primary deficiency; Hyperammonaemia due to isovaleric acidaemia; Hyperammonaemia due to methymalonic acidaemia; Hyperammonaemia due to propionic acidaemia.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CARBAGLU	02439360	200 MG	TABLET FOR SUSPENSION · ORAL	RECORDATI RARE DISEASES

Safety signals and safety-related labeling changes

US FDA 19 Jan 2024 CARBAGLU — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for carglumic acid →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.