WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Lamictal (lamotrigine) is licensed for epilepsy and for the maintenance treatment of bipolar I disorder, and the real procurement questions are the strength and form mix, the valproate titration packs and which generic or brand your registration route accepts.

M Care Exports supplies Lamictal (lamotrigine), the GSK antiepileptic, as an originator brand and also supplies Indian-made lamotrigine generics, such as Lamez tablets and Lamitor DT dispersible tablets, for destinations whose registration accepts them. Lamotrigine is an oral, room-temperature product, so the work is in matching strengths and forms to the indication mix. M Care is a merchant-exporter: we source through licensed channels and dispatch on quote, not from our own manufacturing.

WhatsApp a lamotrigine enquiry → Send enquiry by form
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Lamotrigine exporter and bulk supplier from India.

A typical brief reads: I'm looking for Lamictal 25 mg, 100 mg and 200 mg tablets, and dispersible tablets for children. M Care quotes lamotrigine against your specification: originator Lamictal or generic, which strengths (25, 50, 100, 150 or 200 mg tablets, and 2, 5, 25 or 100 mg dispersible tablets, depending on the label your regulator recognises), pack count, quantity and the registration route in the destination. Pack counts differ by market. The UK SmPC lists packs of 56 for the tablets, while the US label lists bottles of 100 for the 25 mg and 100 mg tablets, so tell us the pack your tender or import licence names. We quote per destination and give no figure until we know these details.

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.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Antiepileptic (antiseizure medicine), also used for bipolar I maintenance, sourced and documented for export.

Lamotrigine is an antiepileptic that is also licensed for bipolar I maintenance. The US label lists adjunctive epilepsy therapy from age 2 (partial-onset seizures, primary generalised tonic-clonic seizures and Lennox-Gastaut generalised seizures), conversion to monotherapy for partial-onset seizures from age 16, and maintenance treatment of bipolar I disorder to delay mood episodes. It is not recommended for acute manic or mixed episodes. The UK SmPC covers adjunctive or monotherapy use in adults and adolescents from 13, adjunctive use and typical absence seizure monotherapy in children aged 2 to 12, and prevention of depressive episodes in bipolar I disorder in adults. The US label lists scored tablets (25, 100, 150 and 200 mg), tablets for oral suspension (2, 5 and 25 mg) and orally disintegrating tablets (25, 50, 100 and 200 mg). The UK SmPC lists tablets (25, 50, 100 and 200 mg) and chewable/dispersible tablets (2, 5, 25 and 100 mg). Lamictal XR is listed on DailyMed as a separate US extended-release product.

Active ingredient

Lamotrigine. Antiepileptic (antiseizure medicine), also used for bipolar I maintenance.

Forms and strengths

25 mg tablet; 50 mg tablet; 100 mg tablet; 150 mg tablet; 200 mg tablet; 2 mg chewable/dispersible tablet; 5 mg chewable/dispersible tablet.

Indications

Lamotrigine, an antiepileptic licensed for adjunctive and monotherapy epilepsy and for maintenance treatment of bipolar I disorder. Supplied as originator Lamictal and licensed generic tablets and dispersible tablets to regulated and semi-regulated markets outside India.

Administration

Oral. Tablet; chewable/dispersible tablet; orally disintegrating tablet.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 lamotrigine are mainly hospital neurology and psychiatry pharmacies, MoH and hospital tender desks running antiseizure medicine lists, licensed importers and distributors in the GCC, Africa and the UK, and procurement programmes that need paediatric dispersible forms alongside adult tablets. A mixed list reads like this: we need a partner for adult tablets, a 2 mg and 5 mg dispersible range, and a clear answer on whether the tender wants the originator or a generic. India is our origin, not a market we sell into.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on lamotrigine.

Lamotrigine is a titration product, and titration is where procurement and pharmacy meet. For adjunctive epilepsy in older patients, the US label gives different schedules: with valproate the starting dose is 25 mg every other day for weeks 1 and 2, then 25 mg daily, while with carbamazepine, phenytoin, phenobarbital or primidone (no valproate) it is 50 mg daily, then 100 mg daily in divided doses. The label states the dose with valproate is less than half the dose needed without it. Exceeding the recommended initial dose or escalation, and concomitant valproate, raise the risk of serious rash, so buyers stocking mixed formularies should carry the low strengths (25 mg, and 2 mg or 5 mg dispersibles) rather than relying on splitting. The UK SmPC warns against giving partial dispersible tablets and says to give the lower number of whole tablets. Per the US label, oestrogen-containing oral contraceptives decrease lamotrigine concentrations by approximately 50%, so doses often need adjusting when they start or stop. Ambient storage applies: the UK SmPC requires no special storage conditions and the US label gives 25 C with excursions to 15 to 30 C, in a dry place (some US presentations add protection from light). No cold chain is needed.

Regulatory & quality

The documentation pack a regulator actually asks for.

Lamotrigine travels on standard ambient lanes, so the documents matter more than the logistics. We provide the batch certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD or eCTD dossier support. Lamotrigine is on the WHO Model List of Essential Medicines under antiseizure medicines, first added in 2017 (TRS 1006), for epilepsy or seizures. The WHO entry does not list bipolar disorder, so a tender for bipolar use should be justified from the national formulary and the label, not the EML. On brand versus generic, the originator in the US and UK is GSK's Lamictal. DailyMed lists generic lamotrigine labels from many manufacturers. Whether the originator or a generic is accepted, and what registration it needs, is set by the destination regulator, so we confirm the route before quoting. We do not claim any Indian brand is registered in a given destination.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for lamotrigine.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Lamotrigine supply, the specific questions.

What is Lamictal 100 mg used for?

Lamictal 100 mg is a tablet strength of lamotrigine. The US label lists adjunctive therapy for partial-onset seizures, primary generalised tonic-clonic seizures and Lennox-Gastaut generalised seizures from age 2, conversion to monotherapy for partial-onset seizures from age 16, and maintenance treatment of bipolar I disorder. The UK SmPC lists epilepsy in adults, adolescents and children, and prevention of depressive episodes in bipolar I disorder in adults. The 100 mg tablet is one step in a titration range, so we confirm your indication mix and strengths before quoting.

Does Lamictal cause a rash, and what should buyers know?

Serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur and the US label carries them as a boxed warning. The risk is higher with concomitant valproate and with exceeding the recommended initial dose or escalation, and the US label notes that the HLA-B*1502 allele is associated with an increased risk in patients of Asian ancestry. The label says Lamictal should be discontinued at the first sign of rash, unless the rash is clearly not drug related. For a procurement desk this means stocking the low strengths and starter packs that support slow titration, and passing the patient information leaflet through with every shipment.

What sets the price of Lamictal for an importer?

We never publish a price. For an importer the landed price depends on originator or generic, the strength and form mix (tablets, dispersible tablets or orally disintegrating tablets), the pack count, the quantity, the destination's registration route and the Incoterms. Lamotrigine needs no cold chain, which removes one cost line. M Care Exports quotes per destination, so send your strengths, pack size and quantity and we respond against that specification.

Is Lamictal approved by the FDA, and is there a generic?

Yes. GlaxoSmithKline LLC holds the US Lamictal label on DailyMed, covering tablets, tablets for oral suspension and orally disintegrating tablets, and Lamictal XR is listed as a separate extended-release product. DailyMed also lists generic lamotrigine labels from many manufacturers, among them Zydus, Alembic, Aurobindo, Dr. Reddy's and Glenmark. We state nothing about the generic position in the EU or India that we have not checked against a regulator page, and we confirm what your destination accepts before quoting.

Which Lamictal strengths exist: 50 mg, 150 mg and 200 mg?

It depends on the market label. The UK SmPC lists Lamictal tablets at 25, 50, 100 and 200 mg, and dispersible tablets at 2, 5, 25 and 100 mg. The US label lists tablets at 25, 100, 150 and 200 mg, tablets for oral suspension at 2, 5 and 25 mg, and orally disintegrating tablets at 25, 50, 100 and 200 mg. A 50 mg tablet and a 150 mg tablet therefore do not both exist under one label, so we quote strengths against the label your regulator recognises.

Can M Care supply both the originator and Indian generics?

Yes. M Care supplies the Lamictal originator brand and Indian-made generics, for example Lamez tablets and Lamitor DT dispersible tablets in 25, 50 and 100 mg. We supply these for destinations whose registration accepts them and we do not claim any Indian brand is registered in a given country. If you write that you are looking for a partner for a single tender, tell us whether the tender names the brand or lamotrigine by INN and we quote that line.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.

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.

Lamotrigine enquiry

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.

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