Regulatory PathRegulatory requirements compared

Active substance

Glimepiride

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMAGLIME 1 mg tablet1 mgTablet · Oral use30 BlisterSAR 10.35Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AMAGLIME 1 mg tablet1 mgTablet · Oral use60 BlisterSAR 16.70Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AMAGLIME 2 mg tablet2 mgTablet · Oral use30 BlisterSAR 13.70Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AMAGLIME 3 mg tablet3 mgTablet · Oral use30 BlisterSAR 23.60Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AMAGLIME 3 mg tablet3 mgTablet · Oral use60 BlisterSAR 42.50Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
AMARYL 1MG TAB1 mgTablet · Oral use30 BlisterSAR 20.80NCE · Prescriptionsanofi-aventisValid
AMARYL 2MG TAB2 mgTablet · Oral use30 BlisterSAR 33.90NCE · Prescriptionsanofi-aventisValid
AMARYL 3MG TAB3 mgTablet · Oral use30 BlisterSAR 47.15NCE · Prescriptionsanofi-aventisValid
AMARYL 6 mg tablet6 mgTablet · Oral use30 BlisterSAR 52.35Generic · Prescriptionsanofi-aventisValid
Amaglime2 mgTablet · Oral use500 BlisterSAR 228.35Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
Amaglime2 mgTablet · Oral use500 BlisterSAR 228.35Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
G-PRIDE 1 mg tablet1 mgTablet · Oral use30 BlisterSAR 8.35Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
G-PRIDE 2 mg tablet2 mgTablet · Oral use30 BlisterSAR 13.70Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
G-PRIDE 3 mg tablet3 mgTablet · Oral use30 BlisterSAR 21.25Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
G-PRIDE 4 mg tablet4 mgTablet · Oral use30 BlisterSAR 24.95Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
GLEMAX 1 mg Tablet1 mgTablet · Oral use30 BlisterSAR 8.35Generic · PrescriptionJordan Sweden Medical and Sterilization Co.Valid
GLEMAX 2 mg Tablet2 mgTablet · Oral use30 BlisterSAR 13.70Generic · PrescriptionJordan Sweden Medical and Sterilization Co.Valid
GLEMAX 3 mg Tablet3 mgTablet · Oral use30 BlisterSAR 21.25Generic · PrescriptionJordan Sweden Medical and Sterilization Co.Valid
GLEMAX 4 mg Tablet4 mgTablet · Oral use30 BlisterSAR 24.95Generic · PrescriptionJordan Sweden Medical and Sterilization Co.Valid
GLEMAX 6 mg Tablet6 mgTablet · Oral use30 BlisterSAR 37.40Generic · PrescriptionJordan Sweden Medical and Sterilization Co.Valid
GLIDE 1MG TABLET1 mgTablet · Oral use30 BlisterSAR 10.35Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
GLIDE 2MG TABLET2 mgTablet · Oral use30 BlisterSAR 13.70Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
GLIDE 3MG TABLET3 mgTablet · Oral use30 BlisterSAR 23.60Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
GLIDE 4MG TABLET4 mgTablet · Oral use30 BlisterSAR 24.95Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
GLIM 1MG TABLETS1 mgTablet · Oral use30 BlisterSAR 19.75Generic · PrescriptionSPIMACO ADDWAEIHValid

42 more — full table

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

ProductStrengthForm · routeApplicantStatusFirst approved
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralDR REDDYS LABS LTDPrescription6 Oct 2005
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralCHARTWELL MOLECULARPrescription6 Oct 2005
GLIMEPIRIDE1MG; 2MG; 4MG; 8MGtablet · oralPRINSTON INCPrescription23 Dec 2005
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralACCORD HLTHCAREPrescription23 Aug 2007
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralCARLSBADPrescription22 Sep 2009
GLIMEPIRIDE1MG; 2MG; 3MG; 4MG; 6MG; 8MGtablet · oralMICRO LABSPrescription29 Jun 2012
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralAUROBINDO PHARMA LTDPrescription29 Jun 2012
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralREGCON HOLDINGSPrescription17 Apr 2013
AMARYL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralSANOFI AVENTIS USDiscontinued30 Nov 1995
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralSENORES PHARMSDiscontinued6 Oct 2005
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralEPIC PHARMA LLCDiscontinued6 Oct 2005
GLIMEPIRIDE3MG; 6MGtablet · oralRANBAXYDiscontinued6 Oct 2005
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralQUAGENDiscontinued28 Nov 2005
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralWATSON LABSDiscontinued3 Feb 2006
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralMYLANDiscontinued10 Feb 2006
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralACTAVIS LABS FL INCDiscontinued26 Apr 2010
GLIMEPIRIDE1MG; 2MG; 4MGtablet · oralHIKMA PHARMSDiscontinued1 Aug 2013
GLIMEPIRIDE1MG; 2MG; 4MG; 8MGtablet · oralRANBAXY LABS LTDDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SANDOZ GLIMEPIRIDE022695891 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ GLIMEPIRIDE022695972 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ GLIMEPIRIDE022696194 MGTABLET · ORALSANDOZ CANADA INCORPORATED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACGLIMEPIRIDE 1 MG TABLET$0.02432per EA23 Sep 2026
US NADACGLIMEPIRIDE 2 MG TABLET$0.03752per EA23 Sep 2026
US NADACGLIMEPIRIDE 4 MG TABLET$0.05069per EA23 Sep 2026
NHS Drug TariffGlimepiride 1mg tablets£1.0930 tablet1 Oct 2026
NHS Drug TariffGlimepiride 2mg tablets£1.0930 tablet1 Oct 2026
NHS Drug TariffGlimepiride 3mg tablets£1.2730 tablet1 Oct 2026
NHS Drug TariffGlimepiride 4mg tablets£1.3230 tablet1 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.

Safety signals and safety-related labeling changes

  • US FDA 21 Dec 2018 AMARYL — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 21 Dec 2017 DUETACT — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for glimepiride →

Combinations containing Glimepiride

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.