Is Metformin + Pioglitazone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Metformin + Pioglitazone, including ACTOSMET 15/850 mg tablet (850,15 mg,mg, Film-coated tablet, SAR 104.50); GLACERA PLUS 15MG/500MG F.C.TABLET (500,15 mg,mg, Film-coated tablet, SAR 83.75); GLACERA PLUS 15MG/850MG F.C.TABLET (850,15 mg,mg, Film-coated tablet, SAR 83.75); GLADOS MET 15/500 TABLETS (500,15 mg,mg, Tablet, SAR 93.05); GLADOS MET 15/850 TABLETS (850,15 mg,mg, Tablet, SAR 93.05).

Is Metformin + Pioglitazone approved by the US FDA?

Drugs@FDA lists 9 application product lines for Metformin + Pioglitazone, including ACTOPLUS MET (Prescription); PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (Prescription); PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (Prescription); PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (Prescription); PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (Prescription).

Is Metformin + Pioglitazone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Metformin + Pioglitazone: Competact.

Active substances

Metformin + Pioglitazone

SFDA 6
US FDA 9
EMA 2
US price lines 2
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACTOSMET 15/850 mg tablet	850,15 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 104.50	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
GLACERA PLUS 15MG/500MG F.C.TABLET	500,15 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 83.75	Generic · Prescription	RIYADH PHARMA	Valid
GLACERA PLUS 15MG/850MG F.C.TABLET	850,15 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 83.75	Generic · Prescription	RIYADH PHARMA	Valid
GLADOS MET 15/500 TABLETS	500,15 mg,mg	Tablet · Oral use	60 Bottle	SAR 93.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
GLADOS MET 15/850 TABLETS	850,15 mg,mg	Tablet · Oral use	60 Bottle	SAR 93.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Glitamomet	15,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 78.85	Generic · Prescription	SPIMACO ADDWAEIH	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
ACTOPLUS MET	850MG;EQ 15MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	29 Aug 2005
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	13 Feb 2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	TORRENT PHARMS LTD	Prescription	13 Feb 2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	TEVA PHARMS USA	Prescription	10 Mar 2014
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	5 Nov 2015
ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TAKEDA PHARMS USA	Discontinued	29 Aug 2005
ACTOPLUS MET XR	1GM;EQ 15MG BASE; 1GM;EQ 30MG BASE	tablet, extended release · oral	TAKEDA PHARMS USA	Discontinued	12 May 2009
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	PHARMOBEDIENT	Discontinued	25 Feb 2011
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE; 850MG;EQ 15MG BASE	tablet · oral	CHARTWELL RX	Discontinued	16 Apr 2013

EMA European Union — centrally authorised medicines

Competact CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 28 Jul 2006 · ATC A10BD05

Therapeutic indication (EMA)

Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

Glubrava Takeda Pharma A/S · Withdrawn · authorised 11 Dec 2007 · ATC A10BD05

Therapeutic indication (EMA)

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PIOGLITAZONE-METFORMIN 15-500	$0.2835	per EA	23 Sep 2026
US NADAC	PIOGLITAZONE-METFORMIN 15-850	$0.23908	per EA	23 Sep 2026
NHS Drug Tariff	Pioglitazone 15mg / Metformin 850mg tablets	£29.18	56 tablet	1 Oct 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.