Prothiaden (dosulepin), earlier known by the USAN name dothiepin, is a tricyclic antidepressant that UK regulatory advice now restricts to patients intolerant of or unresponsive to other antidepressants, and M Care sources UK-licensed generic dosulepin tablets and capsules for markets where prescribers still use it.
M Care Exports supplies dosulepin, sold in the UK today as generic dosulepin tablets and capsules alongside the licensed brand Prothiaden, and known by its earlier USAN name dothiepin. It is a tricyclic antidepressant with an anti-anxiety effect that UK prescribing advice now limits to patients intolerant of or unresponsive to other antidepressants. We are a merchant exporter, not a manufacturer: we source UK-licensed generic dosulepin tablets and capsules through licensed distribution channels and dispatch against buyer specification and destination-market regulatory documentation.
Dosulepin exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes dosulepin against buyer specification: dosage form (25 mg capsules or 75 mg film-coated tablets), pack size and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Dosulepin remains available in the UK both as the licensed Prothiaden brand and as generic product, and because prescribing guidance limits pack quantities for patients at higher risk, we confirm the buyer's intended prescribing pathway and dispensing-quantity limits 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), sourced and documented for export.
Dosulepin hydrochloride is a tricyclic antidepressant (TCA) that inhibits presynaptic reuptake of noradrenaline and serotonin, with additional antihistaminergic and anti-anxiety effects that made it a once-common choice for depression with agitation. It is dosed orally as 25 mg capsules or 75 mg film-coated tablets, not injected, and needs no reconstitution or cold-chain handling. UK licensing now confines its use to patients who are intolerant of, or have not responded to, other antidepressant classes, because dosulepin has a narrower margin between the therapeutic dose and a potentially fatal overdose than most other tricyclics. The originator brand, Prothiaden, remains licensed in the UK alongside generic dosulepin; M Care supplies the generic product. Outside the UK, dosulepin (or dothiepin) remains prescribed in a number of European, South Asian, Southern African and Oceania markets, though it is not marketed in the United States.
Active ingredient
Dosulepin hydrochloride. Tricyclic antidepressant (TCA).
Forms and strengths
25 mg capsule; 75 mg film-coated tablet.
Indications
Dosulepin hydrochloride, a tricyclic antidepressant with an anti-anxiety effect, licensed for depressive illness in patients intolerant of or unresponsive to other antidepressant treatment. Marketed in the UK today both as the licensed Prothiaden brand and as generic dosulepin capsules and tablets; M Care supplies the generic product to regulated and semi-regulated markets outside India.
Administration
Oral. Film-coated tablet and 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 dosulepin are chiefly hospital and community mental-health pharmacies still managing a small caseload of patients established on the drug, MoH tender desks and formulary committees in markets where dosulepin remains a listed option, licensed pharmaceutical wholesalers and importers replenishing generic dosulepin stock, and regulatory affairs teams needing CTD-format documentation to keep a dosulepin registration current in a destination country.
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 dosulepin.
Dosulepin dosing is conservative by design: adults typically start at 75 mg daily, either as a single dose at night or in divided doses, rising to a usual maximum of 150 mg daily, with up to 225 mg reserved for hospital settings under closer monitoring. Elderly patients are usually started at 50 to 75 mg daily, since lower doses are often sufficient and this group is more susceptible to anticholinergic and cardiac effects. The defining prescribing constraint is the narrow margin between the effective dose and a fatal overdose: as few as ten 75 mg tablets have caused death, largely through pro-arrhythmic and pro-convulsive effects, so licensing now restricts new starts to patients who have failed or cannot tolerate other antidepressants, and dispensing quantities should be limited, particularly for patients assessed at higher suicide risk. No reconstitution, admixture or cold-chain handling applies: dosulepin is an oral solid stored below 25°C in its original pack, with a three-year shelf life at manufacture.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, dosulepin travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care manages for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires it, CTD or eCTD-format dossier support so the buyer's own authority can register or maintain the product. Dosulepin is not itself on the current WHO Model List of Essential Medicines: the 2023 update named amitriptyline as the sole essential tricyclic antidepressant for depressive disorders, so tender desks building a formulary from the WHO list should expect amitriptyline as the reference agent and treat dosulepin as a formulary-specific alternative for patients already established on it or unresponsive to other options. On the brand-versus-generic question, buyers have a genuine choice: the Prothiaden brand remains licensed in the UK, alongside generic dosulepin tablets and capsules from other UK licence holders. M Care supplies the current UK-licensed generic product. Dosulepin is not approved for marketing in the United States.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 dosulepin.
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 dosulepin.
- 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.
Dosulepin supply, the specific questions.
Is Prothiaden still available, or only generic dosulepin?
Both. The Prothiaden brand remains licensed and available in the UK, alongside generic dosulepin in 25 mg capsules and 75 mg film-coated tablets from other UK licence holders. M Care supplies the current UK-licensed generic dosulepin rather than the branded Prothiaden pack.
What strengths and dosage forms does M Care supply?
Dosulepin hydrochloride as 25 mg capsules and 75 mg film-coated tablets, matching the UK-licensed generic product range. Tell us your required strength split and pack size and we quote against your specification and destination-market documentation needs.
Why is dosulepin prescribing restricted in the UK?
Dosulepin has a narrower margin between an effective therapeutic dose and a potentially fatal overdose than most other tricyclic antidepressants, with reports of death after as few as ten 75 mg tablets. Current UK licensing therefore limits its use to patients intolerant of, or unresponsive to, other antidepressant options, and advises limited dispensing quantities, particularly for patients at higher risk.
Is dosulepin on the WHO Essential Medicines List?
No. The WHO Model List of Essential Medicines names amitriptyline as its single essential tricyclic antidepressant for depressive disorders following the 2023 update. Dosulepin is not listed, so buyers building a WHO-aligned formulary should treat it as a supplementary or patient-specific option rather than an EML first-line agent.
Can M Care supply dosulepin to GCC or African markets?
Yes, where the product holds or can obtain local registration. Dosulepin continues to be prescribed in a number of markets outside the UK. We confirm your market's registration status and required documentation, typically a CTD or eCTD-aligned dossier plus batch-level certificate of analysis, before quoting.
What documentation does M Care provide with a dosulepin shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where your destination regulator requires local registration or renewal. Given the prescribing restrictions in dosulepin's home market, we also confirm current pack-size and labelling requirements against your destination country's rules before dispatch.
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.