Anafranil (clomipramine) is licensed for obsessive-compulsive disorder and, in UK/EU labelling, depressive illness and phobic states, and it sits on the WHO Essential Medicines List even as the branded product has receded from most formularies in favour of licensed generic clomipramine hydrochloride.
M Care Exports supplies clomipramine hydrochloride, a tricyclic antidepressant marketed internationally as Anafranil, primarily for obsessive-compulsive disorder (OCD) unresponsive to first-line SSRIs. As a merchant exporter, we source FDA- and MHRA-licensed generic clomipramine capsules, the form now stocked on most formularies since Anafranil's own branded presence has thinned out, through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own production.
Clomipramine exporter and bulk supplier from India.
For hospital psychiatry pharmacy, wholesaler and MoH tender orders, M Care quotes clomipramine hydrochloride capsules against buyer specification: strength (10mg, 25mg, 50mg, market-dependent 75mg), indication (OCD is the flagship licensed use; UK/EU labelling extends to depressive illness, phobic states and cataplexy adjunct to narcolepsy) and destination-market regulatory documentation. Because clomipramine carries a boxed suicidality warning and a titration schedule that runs over the first two weeks of therapy, we confirm the buyer's intended patient information leaflet and monitoring protocol before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Tricyclic antidepressant (TCA); dibenzazepine derivative, serotonin and noradrenaline reuptake inhibitor, sourced and documented for export.
Clomipramine is a dibenzazepine-class tricyclic antidepressant (TCA) and a potent, relatively non-selective serotonin and noradrenaline reuptake inhibitor, the pharmacology behind its distinctive licensed use in OCD, a use most other TCAs do not carry. It is an oral-only therapy, needing no reconstitution. The FDA label's sole indication is treatment of obsessions and compulsions in OCD; UK/EU SmPC labelling additionally covers depressive illness especially where sedation is required, obsessional and phobic states, and adjunctive treatment of cataplexy associated with narcolepsy. Destination-country labelling should be checked against this before a quote is finalised. Clomipramine hydrochloride is supplied as 10mg, 25mg and 50mg hard capsules in UK-registered generic lines, with a 75mg capsule strength also listed on the US label; buyers should confirm which strengths their destination regulator has registered.
Active ingredient
Clomipramine hydrochloride. Tricyclic antidepressant (TCA); dibenzazepine derivative, serotonin and noradrenaline reuptake inhibitor.
Forms and strengths
10 mg capsule; 25 mg capsule; 50 mg capsule; 75 mg capsule.
Indications
Clomipramine, a dibenzazepine tricyclic antidepressant, is indicated for obsessive-compulsive disorder and, in UK/EU labelling, depressive illness, phobic states and cataplexy adjunct to narcolepsy. Listed on the WHO Essential Medicines List. Supplied from Indian WHO-GMP facilities as licensed generic clomipramine hydrochloride capsules, the branded Anafranil having receded from several regulated markets, to regulated and semi-regulated markets outside India.
Administration
Oral. Hard capsule.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for clomipramine are hospital and community psychiatry pharmacies managing OCD patients who have not responded to first-line SSRIs, national and regional MoH tender desks running mental-health and neurology formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting mental-health access in markets where local registration is in place. Because Anafranil's own branded stock has thinned in several regulated markets, buyers increasingly specify generic clomipramine hydrochloride by molecule rather than by brand name on a tender.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on clomipramine.
Clomipramine dosing starts low and titrates over roughly two weeks, from an initial 25mg daily up toward maintenance levels, because steady-state plasma levels take two to three weeks to establish given the drug's long elimination half-life; dosage changes made faster than that risk chasing a level that has not yet settled. Like other antidepressants, clomipramine carries a boxed warning for increased suicidal thinking and behaviour in children, adolescents and young adults, so initiation and every dose change need close clinical monitoring, a point worth flagging on any dispensing record for a younger patient. UK/EU labelling advises against use in pregnancy and in women of childbearing potential not using contraception, given an association with cardiac defects on first-trimester exposure, and against breastfeeding since clomipramine passes into breast milk in small quantities. As a tricyclic, clomipramine has a narrow therapeutic index and is cardiotoxic in overdose, a standing reason formulary desks keep quantities dispensed under review. No cold-chain handling or reconstitution is required; capsules store at controlled room temperature.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, clomipramine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Clomipramine is listed on the WHO Model List of Essential Medicines, under medicines for obsessive-compulsive disorders, in 10mg and 25mg oral solid forms, giving it a stronger EML footing than several CNS molecules on comparable tender lists. On the brand-versus-generic question, Anafranil remains the internationally recognised brand name buyers search for, but its branded stock has receded from several regulated markets: the current UK emc listing carries only generic clomipramine hydrochloride capsules, and US brand-name Anafranil supply has also narrowed to a small number of generic manufacturers. Buyers should expect to specify and register generic clomipramine hydrochloride rather than assume branded Anafranil stock is available, and M Care confirms current registration status with the sourcing partner before quoting. Clomipramine is not a scheduled controlled substance in the markets we currently review.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside clomipramine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for clomipramine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Clomipramine supply, the specific questions.
Is Anafranil brand clomipramine still available, or is it generic only now?
Availability varies by market. Anafranil's branded stock has thinned out in several regulated markets: the current UK emc listing for clomipramine carries only generic hard capsules, and US brand supply has also narrowed to a small number of generic manufacturers. Buyers should plan around generic clomipramine hydrochloride availability rather than assume Anafranil brand stock is on hand, and M Care confirms current status before quoting.
What is clomipramine licensed to treat?
The FDA label's sole indication is obsessive-compulsive disorder (OCD), treating the obsessions and compulsions of the condition. UK/EU SmPC labelling is broader: depressive illness especially where sedation is required, obsessional and phobic states, and adjunctive treatment of cataplexy associated with narcolepsy. Check destination-country labelling before a tender submission, since the licensed indication set differs by market.
What strengths of clomipramine does M Care supply?
10mg, 25mg and 50mg hard capsules, which are the strengths currently registered in the UK generic market, plus a 75mg capsule strength listed on the US label. Tell us your destination market and registered strength requirement and we quote the mix accordingly.
Is clomipramine on the WHO Essential Medicines List?
Yes. Clomipramine is listed on the WHO Model List of Essential Medicines under medicines for obsessive-compulsive disorders, in 10mg and 25mg oral solid forms. That gives it a firmer essential-medicines footing than several other CNS molecules a tender desk might compare it against.
Is clomipramine safe to use in pregnancy or while breastfeeding?
UK/EU labelling advises against use in pregnancy and in women of childbearing potential not using contraception, citing an association between first-trimester exposure and cardiac defects, and advises against breastfeeding since clomipramine passes into breast milk in small quantities. This should be reflected in destination-market patient information leaflets and dispensing counselling.
What documentation does M Care provide with a clomipramine shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import, along with confirmation of exactly which brand or generic product and registered strength a shipment contains.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.