Is Glimepiride + Pioglitazone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Glimepiride + Pioglitazone, including DUETACT 30/2 mg tablet (30,2 mg,mg, Tablet, SAR 108.65); DUETACT 30/4 mg tablet (30,4 mg,mg, Tablet, SAR 125.80).

Is Glimepiride + Pioglitazone approved by the US FDA?

Drugs@FDA lists 2 application product lines for Glimepiride + Pioglitazone, including DUETACT (Prescription); PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE (Prescription).

Is Glimepiride + Pioglitazone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glimepiride + Pioglitazone: Tandemact.

Active substances

Glimepiride + Pioglitazone

SFDA 2
US FDA 2
EMA 1
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DUETACT 30/2 mg tablet	30,2 mg,mg	Tablet · Oral use	30 Blister	SAR 108.65	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DUETACT 30/4 mg tablet	30,4 mg,mg	Tablet · Oral use	30 Tablet Container	SAR 125.80	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
DUETACT	2MG;30MG; 4MG;30MG	tablet · oral	TAKEDA PHARMS USA	Prescription	28 Jul 2006
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE	2MG;30MG; 4MG;30MG	tablet · oral	CHARTWELL RX	Prescription	4 Jan 2013

EMA European Union — centrally authorised medicines

Tandemact CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 8 Jan 2007 · ATC A10BD06

Therapeutic indication (EMA)

Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PIOGLITAZONE-GLIMEPIRIDE 30-2	$10.75973	per EA	19 Aug 2026
US NADAC	PIOGLITAZONE-GLIMEPIRIDE 30-4	$10.51761	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

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.