Trileptal (oxcarbazepine) is licensed as monotherapy or adjunctive therapy for focal seizures, and buyers can specify the Novartis brand or a licensed generic tablet or suspension line against the same tender.
Trileptal (oxcarbazepine), originated by Novartis, is an oral carboxamide anticonvulsant used as monotherapy or add-on therapy for focal (partial-onset) seizures, structurally close enough to carbamazepine to matter at the dispensing counter. M Care Exports is a merchant exporter: we source Trileptal and FDA- and MHRA-approved generic oxcarbazepine tablets and suspension through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Oxcarbazepine exporter and bulk supplier from India.
For hospital neurology pharmacy, wholesaler and MoH tender orders, M Care quotes oxcarbazepine tablets and suspension against buyer specification: brand (Trileptal) or generic, strength mix (150 mg, 300 mg, 600 mg tablets or 300 mg/5 mL suspension) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because epilepsy formularies typically fix a patient to one named product once stabilised, we confirm which brand or generic a tender or repeat order actually specifies before quoting, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator.
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.
Carboxamide anticonvulsant; keto analogue of carbamazepine, voltage-gated sodium-channel blocker, sourced and documented for export.
Oxcarbazepine is a carboxamide anticonvulsant, chemically a keto analogue of carbamazepine. It and its active metabolite block voltage-sensitive sodium channels, stabilising hyperexcited neuronal membranes and limiting the repetitive neuronal firing that drives a focal seizure. It was developed specifically to keep carbamazepine's sodium-channel mechanism while reducing enzyme-inducing drug interactions and some tolerability problems. Trileptal's licensed use, per the FDA label and UK SmPC, is monotherapy or adjunctive therapy for focal (partial-onset) seizures with or without secondary generalisation, in adults and children from 4 years (monotherapy) or 2 years (adjunctive) depending on destination-country labelling; it is not indicated for generalised absence or myoclonic seizures. It carries no controlled-drug status, unlike some CNS therapies on the same formulary. Trileptal is supplied as 150 mg, 300 mg and 600 mg film-coated tablets and a 300 mg/5 mL (60 mg/mL) oral suspension, dosed twice daily.
Active ingredient
oxcarbazepine. Carboxamide anticonvulsant; keto analogue of carbamazepine, voltage-gated sodium-channel blocker.
Forms and strengths
150 mg film-coated tablet; 300 mg film-coated tablet; 600 mg film-coated tablet; 300 mg/5 mL oral suspension.
Indications
Oral carboxamide anticonvulsant indicated as monotherapy or adjunctive therapy for focal (partial-onset) seizures, structurally related to carbamazepine, carrying a labelled risk of serious dermatologic reactions (SJS/TEN, HLA-B*1502-linked, though not a boxed warning) and a meaningful carbamazepine cross-sensitivity risk.
Administration
oral. Film-coated tablet and oral suspension.
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 oxcarbazepine are hospital and community neurology pharmacists managing patients newly diagnosed with focal epilepsy or switched from carbamazepine for tolerability, paediatric neurology services using the oral suspension, national and regional MoH tender desks running epilepsy and CNS formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation programmes supporting epilepsy-care access in markets where local registration is in place.
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 oxcarbazepine.
Oxcarbazepine is titrated, not started at a maintenance dose: adults typically begin at 600 mg/day in two divided doses, rising in increments of up to 600 mg/day at roughly weekly intervals to a target of 1,200-2,400 mg/day depending on the regimen; paediatric adjunctive dosing is weight-based, targeting roughly 900-1,800 mg/day by weight band in patients 4-16 years (median around 31 mg/kg/day in trials), or up to 60 mg/kg/day in children aged 2 to under 4, built up over two to four weeks. The counselling point that matters most at dispensing is brand and generic consistency: once a patient is seizure-controlled, an unannounced switch between Trileptal and a generic oxcarbazepine product, or between different generic manufacturers, is a recognised trigger for breakthrough seizures, so formulary changes need the prescriber's sign-off, not a routine substitution. Hyponatraemia (serum sodium below 125 mmol/L) develops in a minority of patients, most often in the first three months, so baseline and early sodium monitoring is standard practice, particularly alongside diuretics or SIADH-risk comedication. Roughly a quarter to a third of patients with a documented carbamazepine hypersensitivity will also react to oxcarbazepine, so a carbamazepine allergy history should prompt caution, not automatic substitution, when a formulary is choosing between the two.
The documentation pack a regulator actually asks for.
As an oral tablet and suspension, oxcarbazepine travels on standard ambient-temperature, moisture-controlled logistics rather than the cold-chain lanes M Care validates for biologics. 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. Oxcarbazepine does not appear on the current WHO Model List of Essential Medicines, which lists carbamazepine and sodium valproate as the EML antiepileptic entries for focal epilepsy; NICE nonetheless recommends oxcarbazepine as an option for adjunctive or, in some cases, first-line treatment of focal seizures, so tender desks should treat it as a mainstream second-generation choice rather than an EML-listed first-line agent. In the EU, Trileptal and its generics are authorised market-by-market through national procedures rather than under a single centralised EMA marketing authorisation, so the exact licensed indications and pack sizes can vary slightly by destination country and should be checked against the local SmPC before a tender specification is finalised. On the brand-versus-generic question, Trileptal remains the originator product from Novartis. FDA-approved and MHRA-licensed generic oxcarbazepine tablets and suspension from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice; because epilepsy patients are sensitive to product switches, M Care always confirms which named product a tender or repeat order specifies rather than substituting on our own initiative. UK buyers should also note a 2024 Department of Health and Social Care supply notification affecting oxcarbazepine 150 mg and 300 mg tablets, which we treat as a live example of why formulary desks keep a secondary export source on file.
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 oxcarbazepine.
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 oxcarbazepine.
- 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.
Oxcarbazepine supply, the specific questions.
Is there a generic version of Trileptal?
Yes. FDA-approved generic oxcarbazepine tablets and oral suspension are registered and marketed in the US, and MHRA-licensed generics are available in the UK, alongside Novartis's Trileptal. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Trileptal or generic oxcarbazepine to our market?
Yes, on an import basis. We source Trileptal through Novartis's licensed Indian distribution channels, and generic oxcarbazepine tablets and suspension through WHO-GMP manufacturer lines, and dispatch against your import authorisation and any local registration your pharmacy or hospital holds.
What strengths of oxcarbazepine does M Care supply?
150 mg, 300 mg and 600 mg film-coated tablets, and a 300 mg/5 mL (60 mg/mL) oral suspension, matching the Trileptal presentation and equivalent licensed generic lines. Tell us your dosing protocol and patient population and we quote the strength mix accordingly.
Why can't a patient be switched between oxcarbazepine brands without checking first?
Once a patient with focal epilepsy is seizure-controlled, an unannounced switch between Trileptal and a generic product, or between different generic manufacturers, is a recognised trigger for breakthrough seizures. Formulary or supplier changes for oxcarbazepine need the prescribing team's sign-off, which is why M Care confirms exactly which named product a tender specifies before quoting.
Is oxcarbazepine on the WHO Essential Medicines List?
No. The WHO Model List carries carbamazepine and sodium valproate as its antiepileptic entries for focal epilepsy, not oxcarbazepine. NICE nonetheless recommends oxcarbazepine as an option for focal seizures, so it functions as a mainstream second-generation choice on most formularies rather than an EML-listed agent.
Does oxcarbazepine carry a boxed warning?
No. Unlike carbamazepine, Trileptal's current FDA label carries no boxed warning. Its Warnings and Precautions section does flag serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and notes that patients carrying the HLA-B*1502 allele, more common in Han Chinese, Thai, Filipino and some Malaysian populations, may be at increased risk. Patients with a documented carbamazepine hypersensitivity also carry a meaningfully raised risk of reacting to oxcarbazepine, so that history should be checked before dispensing.
What documentation does M Care provide with an oxcarbazepine 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, plus confirmation of exactly which brand or generic product a shipment contains, given how sensitive epilepsy patients are to product switches.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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.