Regulatory PathRegulatory requirements compared

Active substance

Gemfibrozil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LOPID600 mgFilm-coated tablet · Oral use30 BlisterSAR 49.35NCE · PrescriptionPfizer Pharma GmbHValid
Indications — CHI Daman Drug Formulary

DYSLIPIDEMIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
LOPID600MGtablet · oralPFIZER PHARMSPrescription21 Dec 1981
GEMFIBROZIL600MGtablet · oralCHARTWELL MOLECULESPrescription27 Sep 1993
GEMFIBROZIL600MGtablet · oralINVAGEN PHARMSPrescription27 Jul 2006
GEMFIBROZIL600MGtablet · oralEPIC PHARMA LLCPrescription26 Mar 2007
GEMFIBROZIL600MGtablet · oralIMPAX PHARMSPrescription1 Jun 2007
GEMFIBROZIL600MGtablet · oralNORTHSTAR HLTHCAREPrescription13 Sep 2010
GEMFIBROZIL600MGtablet · oralAUROBINDO PHARMA LTDPrescription16 Sep 2015
GEMFIBROZIL600MGtablet · oralCADILA PHARMS LTDPrescription17 Jun 2016
GEMFIBROZIL600MGtablet · oralASCENT PHARMS INCPrescription13 Jan 2021
LOPID200MG; 300MGcapsule · oralPFIZER PHARMSDiscontinued21 Dec 1981
GEMFIBROZIL300MGcapsule · oralNATCODiscontinued25 Jan 1993
GEMFIBROZIL600MGtablet · oralTEVADiscontinued31 Oct 1993
GEMFIBROZIL600MGtablet · oralPHARMOBEDIENTDiscontinued16 Feb 1995
GEMFIBROZIL600MGtablet · oralWATSON LABSDiscontinued28 Apr 1995
GEMFIBROZIL600MGtablet · oralCHARTWELL RXDiscontinued29 Sep 1995
GEMFIBROZIL600MGtablet · oralAPOTEXDiscontinued20 Jul 1998
GEMFIBROZIL600MGtablet · oralSUN PHARM INDS INCDiscontinued29 Dec 2008
GEMFIBROZIL600MGtablet · oralHIKMA PHARMSDiscontinued16 Aug 2010
GEMFIBROZIL600MGtablet · oralCADILADiscontinued28 Aug 2018
GEMFIBROZIL300MGcapsule · oralPUREPAC PHARMDiscontinued
GEMFIBROZIL600MGtablet · oralWATSON LABSDiscontinued
GEMFIBROZIL600MGtablet · oralPUREPAC PHARMDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
TEVA-GEMFIBROZIL02142074600 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACGEMFIBROZIL 600 MG TABLET$0.10376per EA23 Sep 2026
NHS Drug TariffGemfibrozil 300mg capsules£31.76100 capsule1 Oct 2026
NHS Drug TariffGemfibrozil 600mg tablets£35.5756 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

All safety entries for gemfibrozil →

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.