Is Metformin + Sitagliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 28 valid registrations of Metformin + Sitagliptin, including CRONOXAM PLUS (50,850 mg,mg, Film-coated tablet, SAR 88.00); CRONOXAM PLUS (50,1000 mg,mg, Film-coated tablet, SAR 91.20); GLIPTAMET (1000,50 mg,mg, Film-coated tablet, SAR 106.40); GLIPTAMET (850,50 mg,mg, Film-coated tablet, SAR 102.70); Glycimille (850/50 mg, Film-coated tablet, SAR 90.60).

Is Metformin + Sitagliptin approved by the US FDA?

Drugs@FDA lists 7 application product lines for Metformin + Sitagliptin, including JANUMET (Prescription); JANUMET XR (Prescription); ZITUVIMET (Prescription); ZITUVIMET XR (Prescription); SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription).

Is Metformin + Sitagliptin authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Metformin + Sitagliptin: Efficib, Janumet, Velmetia, Ristfor, Sitagliptin / Metformin hydrochloride Mylan, Sitagliptin / Metformin hydrochloride Sun.

Active substances

Metformin + Sitagliptin

SFDA 30
US FDA 7
EMA 7
Health Canada 46
US price lines 12
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
CRONOXAM PLUS	50,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	APOTEX	Valid
CRONOXAM PLUS	50,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 91.20	Generic · Prescription	APOTEX	Valid
GLIPTAMET	1000,50 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 106.40	NCE · Prescription	SPIMACO ADDWAEIH	Valid
GLIPTAMET	850,50 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 102.70	NCE · Prescription	SPIMACO ADDWAEIH	Valid
Glycimille	850/50 mg	Film-coated tablet · Oral use	60 Blister	SAR 90.60	Generic · Prescription	Pharco International pharmaceutical company	Valid
Glycimille	1000,50 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 93.85	Generic · Prescription	Pharco International pharmaceutical company	Valid
JANUMET	1000,50 mg,mg	Tablet · Oral use	56 Blister	SAR 94.70	NCE · Prescription	MERCK SHARP & DOHME	Valid
JANUMET	850,50 mg,mg	Tablet · Oral use	56 Blister	SAR 94.70	NCE · Prescription	MERCK SHARP & DOHME	Valid
JANUMET XR	500,50 mg,mg	Extended-release tablet · Oral use	56 Bottle	SAR 168.65	NCE · Prescription	MERCK SHARP AND DOHME LLC	Valid
JANUMET XR	1000,50 mg,mg	Extended-release tablet · Oral use	56 Bottle	SAR 168.65	NCE · Prescription	MERCK SHARP AND DOHME LLC	Valid
JANUMET XR	1000,100 mg,mg	Extended-release tablet · Oral use	28 Bottle	SAR 168.65	NCE · Prescription	MERCK SHARP AND DOHME LLC	Valid
Meligamet 50 m / 1000 mg	1000,50 mg,mg	Tablet · Oral use	60 Blister	SAR 98.80	Generic · Prescription	Saudi Amarox	Valid
Meligamet 50 mg / 850 mg	850,50 mg,mg	Tablet · Oral use	60 Blister	SAR 95.35	Generic · Prescription	Saudi Amarox	Valid
SITagliptin - MetFORMIN Cooper	1000,50 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 97.70	Generic · Prescription	Cooper Pharma Arabia	Valid
Sita Plus	50,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 91.20	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Sita Plus	50,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Sitagliptin/Metformin Cooper	850,50 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 94.30	Generic · Prescription	Cooper Pharma Arabia	Valid
Sitavia-MET	50,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 91.20	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Sitavia-MET	50,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Sitavia-MET	50,500 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 85.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Sitavic	50,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 91.20	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Sitavic	50,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Sitfort	50,1000 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 91.20	Generic · Prescription	RIYADH PHARMA	Valid
Sitfort	50,850 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	RIYADH PHARMA	Valid
Xitamet	850,50 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 88.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid

5 more — full table

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
JANUMET	500MG;EQ 50MG BASE; 1GM;EQ 50MG BASE	tablet · oral	MSD SUB MERCK	Prescription	30 Mar 2007
JANUMET XR	500MG;EQ 50MG BASE; 1GM;EQ 50MG BASE; 1GM;EQ 100MG BASE	tablet, extended release · oral	MSD SUB MERCK	Prescription	2 Feb 2012
ZITUVIMET	500MG;50MG; 1GM;50MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	3 Nov 2023
ZITUVIMET XR	500MG;50MG; 1GM;50MG; 1GM;100MG	tablet, extended release · oral	ZYDUS LIFESCIENCES	Prescription	18 Jul 2024
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 50MG BASE; 1GM;EQ 50MG BASE; 1GM;EQ 100MG BASE	tablet, extended release · oral	PH HEALTH	Prescription	4 Jun 2025
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 50MG BASE; 1GM;EQ 50MG BASE	tablet · oral	SANDOZ	Prescription	2 Dec 2025
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 50MG BASE; 1GM;EQ 50MG BASE	tablet · oral	APOTEX	Prescription	30 Apr 2026

EMA European Union — centrally authorised medicines

Efficib Merck Sharp and Dohme B.V · Authorised · authorised 15 Jul 2008 · ATC A10BD07

Therapeutic indication (EMA)

For patients with type-2 diabetes mellitus: Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Efficib is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Efficib is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Efficib is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Janumet Merck Sharp & Dohme B.V. · Authorised · authorised 16 Jul 2008 · ATC A10BD07

Therapeutic indication (EMA)

For patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Janumet is indicated as triple combination therapy with a PPAR agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Janumet is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Velmetia Merck Sharp & Dohme B.V. · Authorised · authorised 16 Jul 2008 · ATC A10BD07

Therapeutic indication (EMA)

For patients with type-2 diabetes mellitus: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

Ristfor Merck Sharp & Dohme B.V. · Authorised · authorised 15 Mar 2010 · ATC A10BD07

Therapeutic indication (EMA)

For patients with type-2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPAR?) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Sitagliptin / Metformin hydrochloride Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 16 Feb 2022 · ATC A10BD07

Therapeutic indication (EMA)

For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride Mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist. Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Sitagliptin / Metformin hydrochloride Sun Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 31 Mar 2023 · ATC A10BD07

Therapeutic indication (EMA)

For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Sitagliptin / Metformin hydrochloride Accord Accord Healthcare S.L.U. · Lapsed · authorised 22 Jul 2022 · ATC A10BD07

Therapeutic indication (EMA)

For adult patients with type 2 diabetes mellitus: It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02557711	50 MG; 500 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02557738	50 MG; 850 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02557746	1000 MG; 50 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE	02509415	50 MG; 500 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE	02509423	850 MG; 50 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE	02509431	50 MG; 1000 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN-METFORMIN	02435772	500 MG; 50 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN-METFORMIN	02435780	50 MG; 850 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN-METFORMIN	02435799	50 MG; 1000 MG	TABLET · ORAL	APOTEX INC
APO-SITAGLIPTIN/METFORMIN XR	02506270	50 MG; 500 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-SITAGLIPTIN/METFORMIN XR	02506289	1000 MG; 50 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-SITAGLIPTIN/METFORMIN XR	02506297	100 MG; 1000 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
AURO-SITAGLIPTIN HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	02547805	50 MG; 500 MG	TABLET · ORAL	AURO PHARMA INC
AURO-SITAGLIPTIN HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	02547813	50 MG; 850 MG	TABLET · ORAL	AURO PHARMA INC
AURO-SITAGLIPTIN HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	02547821	50 MG; 1000 MG	TABLET · ORAL	AURO PHARMA INC
JAMP SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02556189	500 MG; 50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02556197	850 MG; 50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP SITAGLIPTIN HYDROCHLORIDE / METFORMIN	02556200	50 MG; 1000 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JANUMET	02333856	50 MG; 500 MG	TABLET · ORAL	MERCK CANADA INC
JANUMET	02333872	1000 MG; 50 MG	TABLET · ORAL	MERCK CANADA INC
JANUMET XR	02416786	500 MG; 50 MG	TABLET (EXTENDED-RELEASE) · ORAL	MERCK CANADA INC
JANUMET XR	02416794	50 MG; 1000 MG	TABLET (EXTENDED-RELEASE) · ORAL	MERCK CANADA INC
JANUMET XR	02416808	100 MG; 1000 MG	TABLET (EXTENDED-RELEASE) · ORAL	MERCK CANADA INC
PRO-SITAGLIPTIN-METFORMIN	02552817	500 MG; 50 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-SITAGLIPTIN-METFORMIN	02552825	50 MG; 850 MG	TABLET · ORAL	PRO DOC LIMITEE

21 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	JANUMET 50-1,000 MG TABLET	$5.27929	per EA	23 Sep 2026
US NADAC	JANUMET 50-500 MG TABLET	$5.28403	per EA	23 Sep 2026
US NADAC	JANUMET XR 100-1,000 MG TABLET	$10.55592	per EA	23 Sep 2026
US NADAC	JANUMET XR 50-1,000 MG TABLET	$5.27807	per EA	23 Sep 2026
US NADAC	JANUMET XR 50-500 MG TABLET	$5.283	per EA	23 Sep 2026
US NADAC	SITAGLIPTIN PHOSPHATE-METFORMIN 50 MG-1,000 MG TABLET	$1.75986	per EA	5 Aug 2026
US NADAC	SITAGLIPTIN PHOSPHATE-METFORMIN 50 MG-500 MG TABLET	$1.92131	per EA	5 Aug 2026
US NADAC	ZITUVIMET 50-1,000 MG TABLET	$5.03055	per EA	23 Sep 2026
US NADAC	ZITUVIMET 50-500 MG TABLET	$5.05824	per EA	23 Sep 2026
US NADAC	ZITUVIMET XR 100-1,000 MG TAB	$10.07916	per EA	23 Sep 2026
US NADAC	ZITUVIMET XR 50-1,000 MG TABLET	$5.01928	per EA	23 Sep 2026
US NADAC	ZITUVIMET XR 50-500 MG TABLET	$5.00957	per EA	20 May 2026
NHS Drug Tariff	Sitagliptin 50mg / Metformin 1g tablets	£3.51	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.