Regulatory PathRegulatory requirements compared

Active substance

Clomipramine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANAFRANIL TAB 10MG10 mgCoated tablet · Oral use30 BlisterSAR 17.90NCE · PrescriptionTEOFARMA S.R.LValid
ANAFRANIL TABLETS 25 MG25 mgCoated tablet · Oral use30 BlisterSAR 21.40NCE · PrescriptionTEOFARMA S.R.LValid
Indications — CHI Daman Drug Formulary

ANXIETY DISORDERS; DEPRESSION; NARCOLEPSY AND CATAPLEXY

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

ProductStrengthForm · routeApplicantStatusFirst approved
ANAFRANIL25MG; 50MG; 75MGcapsule · oralSPECGX LLCPrescription29 Dec 1989
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralCHARTWELL RXPrescription29 Mar 1996
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralTAROPrescription31 Dec 1996
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralSANDOZPrescription25 Jun 1997
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralZYDUS PHARMSPrescription27 Dec 2017
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralLUPINPrescription21 Nov 2018
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralMANKIND PHARMAPrescription8 Apr 2019
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralJUBILANT CADISTAPrescription21 Oct 2019
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralLEADINGPrescription7 Feb 2020
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralMICRO LABSPrescription22 Jun 2020
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralUNIQUEPrescription7 Aug 2020
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralALEMBICPrescription4 Aug 2021
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralAUROBINDO PHARMAPrescription20 Mar 2023
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralWATSON LABSDiscontinued27 Nov 1996
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralTEVADiscontinued4 Apr 1997
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralTEVADiscontinued26 Aug 1997
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralPHARMOBEDIENTDiscontinued30 Apr 1998
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralWATSON LABSDiscontinued30 Sep 1998
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralAMNEAL PHARMS CODiscontinued31 Oct 2018
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralTP ANDA HOLDINGSDiscontinued3 Apr 2020
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralRK PHARMADiscontinued22 Jun 2020
CLOMIPRAMINE HYDROCHLORIDE25MG; 50MG; 75MGcapsule · oralAJANTA PHARMA LTDDiscontinued2 Oct 2020

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ANAFRANIL0032401925 MGTABLET · ORALAPOTEX INC
ANAFRANIL0033056610 MGTABLET · ORALAPOTEX INC
ANAFRANIL0040259150 MGTABLET · ORALAPOTEX INC
TARO-CLOMIPRAMINE0249750625 MGCAPSULE · ORALTARO PHARMACEUTICALS INC
TARO-CLOMIPRAMINE0249751450 MGCAPSULE · ORALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLOMIPRAMINE 25 MG CAPSULE$0.18882per EA23 Sep 2026
US NADACCLOMIPRAMINE 50 MG CAPSULE$0.25815per EA23 Sep 2026
US NADACCLOMIPRAMINE 75 MG CAPSULE$0.2501per EA23 Sep 2026
NHS Drug TariffClomipramine 10mg capsules£3.5428 capsule1 Oct 2026
NHS Drug TariffClomipramine 25mg capsules£4.9528 capsule1 Oct 2026
NHS Drug TariffClomipramine 50mg capsules£8.9028 capsule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 24.4. Medicines for obsessive compulsive disorders · core
    Obsessive-compulsive disorder
    Oral > Solid: 10 mg (hydrochloride); 25 mg (hydrochloride)

Safety signals and safety-related labeling changes

All safety entries for clomipramine →

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.