Amitriptyline, once sold in the US as Elavil and still marketed in Australia as Endep, is licensed for depression and, off the antidepressant indication, for neuropathic pain and migraine prophylaxis, and FDA, MHRA and TGA-approved generic amitriptyline tablets and oral solution now cover almost every formulary that once carried the originator brand.
M Care Exports supplies amitriptyline, a tricyclic antidepressant first approved by the FDA in 1961 under AstraZeneca's Elavil brand (voluntarily discontinued in the US but never withdrawn for safety or effectiveness) and still registered in Australia as Endep. As a merchant exporter, M Care is not the manufacturer: we source WHO-GMP generic amitriptyline tablets and oral solution through licensed Indian distribution and manufacturing channels and dispatch on quote against buyer specification.
Amitriptyline exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes amitriptyline against buyer specification: tablet strength mix (10 mg, 25 mg, 50 mg or higher), oral solution where a paediatric or dysphagic-patient formulary line is needed, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because amitriptyline is dosed very differently for depression than for neuropathic pain or migraine prophylaxis, and carries an FDA boxed warning on suicidality in patients under 25, we confirm the buyer's intended formulary use and patient information leaflet 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.
Amitriptyline is a tricyclic antidepressant (TCA) that inhibits the reuptake of noradrenaline and serotonin at the neuronal membrane, with additional anticholinergic and antihistaminic activity that accounts for much of its side-effect profile. The UK SmPC's flagship indication is treatment of depressive illness in adults, with additional licensed use for neuropathic pain, migraine prophylaxis and, in children aged 6 and over when other measures have failed, nocturnal enuresis with an organic cause excluded. It is one of the oldest molecules on the WHO Model List of Essential Medicines, listed since 1977 as the representative tricyclic antidepressant for depressive disorders, which keeps it on public-sector formularies even where newer antidepressants have taken first-line status. It is dosed orally, not injected, and needs no reconstitution. Amitriptyline is supplied as film-coated tablets (commonly 10 mg, 25 mg and 50 mg, with higher strengths available in some markets) and as an oral solution for patients who cannot swallow tablets, taken once or in divided doses daily depending on indication.
Active ingredient
Amitriptyline hydrochloride. Tricyclic antidepressant (TCA).
Forms and strengths
10 mg film-coated tablet; 25 mg film-coated tablet; 50 mg film-coated tablet; 10 mg/5ml oral solution.
Indications
Amitriptyline hydrochloride, a tricyclic antidepressant indicated for depressive illness in adults, with additional licensed use for neuropathic pain, migraine prophylaxis and, in children aged 6 and over, nocturnal enuresis. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated export markets.
Administration
Oral. Film-coated tablet; oral solution.
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 amitriptyline are mainly hospital and community mental-health pharmacies, primary-care formulary committees, MoH tender desks stocking the WHO Essential Medicines List, and NGO mental-health programmes, alongside pain clinics prescribing it off-label for neuropathic pain. Because it is a decades-old generic molecule with no cold-chain requirement and a low unit cost, demand is driven by formulary breadth and reliable tender fulfilment rather than brand loyalty; the deciding factor for a tender desk is usually WHO-GMP documentation and consistent lead time, not which manufacturer's name is on the strip. India is our origin. We do not sell into the Indian market. Amitriptyline is exported only, and each shipment carries the destination-specific regulatory pack the buyer's authority requires.
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 amitriptyline.
Amitriptyline dosing depends heavily on indication: depression typically starts low and titrates upward at night because of sedation, while neuropathic pain and migraine prophylaxis use markedly lower doses than the antidepressant range, so a tender specification should always state the intended use. It has a narrow therapeutic index in overdose, with cardiotoxicity (QT prolongation, arrhythmia) the principal risk, which is why the FDA label and UK SmPC both instruct prescribers to limit quantities dispensed to potentially suicidal patients. The FDA carries a boxed warning on increased suicidality risk in patients under 25, and the UK SmPC lists severe cutaneous adverse reactions, including DRESS, typically presenting two to six weeks after starting treatment. Anticholinergic effects (dry mouth, blurred vision, constipation, urinary retention) are common and worth flagging on any patient information leaflet supplied with a shipment. There is no cold-chain requirement: film-coated tablets are stored below 25 degrees Celsius with a standard shelf life, and the oral solution should be kept out of direct light. Renal or hepatic impairment and elderly patients warrant a lower starting dose and closer monitoring.
The documentation pack a regulator actually asks for.
Amitriptyline is off-patent worldwide and has generic marketing authorisations from the FDA, MHRA and TGA, alongside the originator record: AstraZeneca's Elavil (NDA 012703, first approved 1961) was voluntarily discontinued in the US market but the FDA confirmed in 2017 this was not for safety or effectiveness, so ANDAs referencing it remain approvable, and Endep remains a registered amitriptyline brand on Australia's Register of Therapeutic Goods. It is not a controlled drug in the UK; it is simply prescription-only (POM). M Care packs each shipment with WHO-GMP CoPP and manufacturing licence documentation, batch-specific CoA/MoA, destination-language pack inserts, and standard ambient-temperature handling records, and can align CTD/eCTD or country-specific dossiers to the destination regulator's requirements. As a merchant exporter M Care does not hold and does not claim WHO-GMP or WHO-PQ status of its own; the WHO-GMP certification sits with the manufacturing site, and M Care sources against it.
The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.
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 amitriptyline.
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 amitriptyline.
- 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.
Amitriptyline supply, the specific questions.
Is Elavil still available, or only generic amitriptyline?
AstraZeneca's Elavil brand was withdrawn from active US marketing, and the FDA confirmed in 2017 that this was not for reasons of safety or effectiveness, meaning generic ANDAs referencing it remain approvable. In practice almost every current supply of amitriptyline, in the US and elsewhere, is the generic molecule rather than the Elavil brand. Australia is an exception: Endep remains a registered amitriptyline brand there. M Care quotes generic amitriptyline tablets and oral solution sourced through licensed Indian manufacturing and distribution channels.
What strengths and dosage forms can M Care quote?
M Care quotes amitriptyline film-coated tablets, most commonly at 10 mg, 25 mg and 50 mg, with higher strengths available from some manufacturer lines depending on destination market. An oral solution is also available for paediatric or dysphagic-patient use. Confirm the required strength mix and pack size against your tender specification when you send an enquiry, and we will match it against manufacturer lines on the M Care roster.
What is amitriptyline licensed for, beyond depression?
The UK SmPC lists depressive illness in adults as the flagship indication, alongside neuropathic pain, migraine prophylaxis, and, in children aged 6 and over once an organic cause has been excluded and other measures have failed, nocturnal enuresis. Dosing differs substantially between these uses, with pain and migraine doses generally much lower than antidepressant doses, so we always confirm intended formulary use before quoting.
Is amitriptyline a controlled drug?
No. Amitriptyline is prescription-only (POM) in the UK and is not listed on any UK controlled drug schedule, and it carries no equivalent controlled-substance schedule in most destination markets we serve. It does carry an FDA boxed warning on increased suicidality risk in patients under 25 and label cautions on cardiotoxicity in overdose, which we flag on the pack insert supplied with each shipment.
Does amitriptyline need cold-chain shipping?
No. Amitriptyline tablets are stored below 25 degrees Celsius as standard ambient conditions with a typical shelf life of 36 months from manufacture, and no refrigeration or cold-chain handling is required. The oral solution should be kept away from direct light. We provide standard temperature-monitoring and handling records for the shipment regardless.
Is amitriptyline on the WHO Essential Medicines List?
Yes. Amitriptyline has been on the WHO Model List of Essential Medicines since 1977 as the representative tricyclic antidepressant for depressive disorders, and current EML reviews have kept it as the sole tricyclic antidepressant on the list. This keeps it on public-sector formularies and MoH tender lists across the markets M Care serves, even where newer antidepressant classes have taken first-line clinical status.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.