Phenytoin, sold as Dilantin in the US and Epanutin in the UK, is a hydantoin anticonvulsant supplied as capsules, oral suspension, chewable tablets and a 50 mg/mL injection, none of them labelled for refrigeration.
M Care Exports supplies phenytoin, including Dilantin and Epanutin brands and Indian-made lines, to hospital pharmacies, MoH and hospital tender desks, importers and distributors in the GCC, Africa and the UK. If you are looking for capsules, oral suspension, chewable tablets or injection, send the destination, the presentation and the quantity, and we quote per destination.
Also marketed as Dilantin-125.
Phenytoin exporter and bulk supplier from India.
"We need a partner for Dilantin" is a typical way for a hospital pharmacy or a tender desk to start an enquiry, and the first question is which presentation. Phenytoin is not one product but several, and the US labels say that switching between the sodium salt and the free acid forms may need dosage adjustment and serum level monitoring. In the US, Drugs@FDA lists Dilantin extended phenytoin sodium capsules (30 mg and 100 mg), Dilantin-125 oral suspension (125 mg phenytoin per 5 mL) and Dilantin Infatabs 50 mg chewable tablets as prescription products, while the brand-name Dilantin injection is listed as discontinued; the injection label we reviewed is a nonproprietary phenytoin sodium injection at 50 mg/mL. The UK emc lists Epanutin 30 mg/5 mL oral suspension and Epanutin Infatabs 50 mg chewable tablets, both with Viatris Products Limited as marketing authorisation holder. M Care is a merchant-exporter. We supply originator or regulator-registered brands and Indian-made lines such as Dilantin 100 mg capsules (Indian-market pack), Eptoin and Fentinol, for destinations whose registration accepts them. The landed price for an importer depends on the brand or Indian-made line, the strength and pack, the quantity, the destination's registration route and Incoterms. None of these presentations is labelled for refrigeration, so cold chain is not the cost driver. M Care quotes per destination.
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.
Hydantoin anticonvulsant, sourced and documented for export.
Phenytoin is a hydantoin anticonvulsant. The US Dilantin capsule label (extended phenytoin sodium capsules, revised 4/2025) gives the indications as tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery; Drugs@FDA lists the capsules in 30 mg and 100 mg extended strengths. Dilantin-125 is a 125 mg phenytoin/5 mL oral suspension (label revised 3/2022). Dilantin Infatabs are 50 mg phenytoin scored chewable tablets (revised 7/2024). The DailyMed phenytoin sodium injection label (manufactured by Hikma, 50 mg/mL, 2 mL and 5 mL single-dose vials) covers generalised tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. The UK Epanutin 30 mg/5 mL oral suspension SmPC (Viatris Products Limited, revised 12/2025) lists tonic-clonic seizures, partial seizures or a combination of these, and seizures occurring during or following neurosurgery and/or severe head injury, and notes use in trigeminal neuralgia only as second-line therapy if carbamazepine is ineffective or not tolerated. The WHO Model List 2023 includes phenytoin injection 50 mg/mL (phenytoin sodium), oral liquid 30 mg/5 mL (phenytoin), solid oral dosage form 25 mg, 50 mg and 100 mg (phenytoin sodium) and chewable tablet 50 mg (phenytoin).
Active ingredient
Phenytoin sodium (capsules, injection) and phenytoin (oral suspension, chewable tablets). Hydantoin anticonvulsant.
Forms and strengths
30 mg extended phenytoin sodium capsule (Dilantin, US); 100 mg extended phenytoin sodium capsule (Dilantin, US; Indian-market pack supplied); 50 mg phenytoin chewable tablet (Dilantin Infatabs US, Epanutin Infatabs UK); 125 mg phenytoin/5 mL oral suspension (Dilantin-125, US); 30 mg phenytoin/5 mL oral suspension (Epanutin, UK); 50 mg/mL phenytoin sodium injection, 2 mL and 5 mL single-dose vials (US label).
Indications
Phenytoin is a hydantoin anticonvulsant supplied by M Care Exports as originator or regulator-registered brands and Indian-made lines in capsule, oral suspension, chewable tablet and injection presentations, quoted per destination.
Administration
Oral, Intravenous. Extended capsule, oral suspension, chewable tablet and solution for injection.
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 are hospital pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for phenytoin 50 mg/mL injection for a neurology tender" or "We need a partner for Dilantin 100 mg capsules and phenytoin oral suspension". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE and the MHRA in the UK, and we align the offer with it before quoting. M Care supplies originator or regulator-registered brands and Indian-made lines, and we do not claim that any Indian-made brand is registered in a given destination. Whether a destination accepts a given line, and the route that applies, depends on the regulator, and M Care Exports confirms it per enquiry.
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 phenytoin.
Specify the salt and the presentation on every order line. The US labels state that the free acid form contains approximately 8% more drug than the sodium salt, and the UK SmPC states that 100 mg of phenytoin sodium is equivalent to 92 mg of phenytoin on a molecular weight basis but that these are not necessarily biologically equivalent. The US labels advise dosage adjustment and serum level monitoring when switching, and the UK SmPC advises serum level monitoring when the dosage form changes. The US labels give a clinically effective total serum concentration of 10 to 20 mcg/mL (unbound 1 to 2 mcg/mL), and advise monitoring unbound levels in renal or hepatic impairment or hypoalbuminaemia. For the injection, the US label carries a boxed warning on cardiovascular risk with rapid infusion and states that the rate should not exceed 50 mg per minute in adults. It also describes purple glove syndrome, with oedema, discolouration and pain distal to the injection site. Storage is 20 to 25 °C for the capsules, Infatabs, Dilantin-125 and injection (the Dilantin-125 label adds protect from light and do not freeze, and the injection label permits excursions to 15 to 30 °C). The UK suspension and Infatabs are not to be stored above 25 °C.
The documentation pack a regulator actually asks for.
None of the presentations above is labelled for refrigeration. The US labels state 20 to 25 °C for Dilantin capsules, Infatabs, Dilantin-125 (protect from light, do not freeze) and the injection (excursions permitted to 15 to 30 °C). The UK Epanutin suspension states "Do not store above 25°C" with a shelf life of 3 years. These are ambient-lane consignments, and M Care confirms transit temperature documentation per tender. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. M Care Exports is a merchant-exporter, not a manufacturer, and its supply is WHO-GMP sourced. We state the source and status of each line before quoting, and make no claim that an Indian-made line is registered in a destination unless the regulator's record shows it.
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 phenytoin.
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 phenytoin.
- 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.
Phenytoin supply, the specific questions.
We are looking for Dilantin 100 mg. What can M Care supply?
Drugs@FDA lists Dilantin extended phenytoin sodium capsules in 30 mg and 100 mg strengths as prescription products in the US. M Care supplies originator or regulator-registered brands and Indian-made lines. Indian-made examples include Dilantin 100 mg capsules (Indian-market pack), Eptoin and Fentinol. We do not claim these Indian-made brands are registered in any destination. Send the destination, strength, pack and quantity, and we confirm which line your regulator accepts and quote per destination.
What is the generic name of Dilantin, and is there a generic?
The nonproprietary name is phenytoin. The Dilantin capsules contain phenytoin sodium (labelled extended phenytoin sodium capsules), while Dilantin Infatabs and Dilantin-125 use the free acid form of phenytoin. Drugs@FDA lists the brand-name Dilantin injection as discontinued, and the DailyMed phenytoin sodium injection label we reviewed (manufactured by Hikma) is marketed under an Abbreviated New Drug Application under the nonproprietary name. We did not confirm the full generic landscape for each presentation in the US, EU or UK, so M Care confirms the registered options for your destination per enquiry. The labels advise care, with serum level monitoring, when changing between salt and free acid forms.
Is Dilantin syrup the same as Dilantin-125 oral suspension?
There is no syrup on the labels we reviewed. The US product is Dilantin-125, an oral suspension of 125 mg phenytoin per 5 mL, and its label says to store at 20 to 25 °C, protect from light and do not freeze. The UK equivalent is Epanutin 30 mg/5 mL oral suspension, which is a viscous cherry red coloured suspension with the instruction not to store above 25 °C. The WHO Model List 2023 lists an oral liquid of 30 mg/5 mL (phenytoin). Because strengths differ by market, state the per-5 mL strength on your enquiry.
What is a Dilantin level, and what do the labels say about monitoring?
A Dilantin level is a serum phenytoin concentration. The US labels give a clinically effective serum total concentration of 10 to 20 mcg/mL, with unbound phenytoin at 1 to 2 mcg/mL, and advise monitoring unbound phenytoin in renal or hepatic impairment or hypoalbuminaemia. The UK SmPC gives a usual clinically effective level of 10 to 20 mcg/mL and advises serum level monitoring when the dosage form changes. M Care does not interpret levels for clinicians. This is label information for procurement teams.
What is the Dilantin dose?
M Care does not give dosing advice. Dose is set by the prescriber against the label for the product in use. For procurement purposes, the UK Epanutin SmPC states that changes in dosage should not be carried out at intervals shorter than 7 to 10 days, and the US Infatabs label says steady-state levels are reached at least 7 to 10 days after starting therapy. The labels also state that dosage adjustment and serum level monitoring may be needed when switching between the free acid and sodium salt forms, so order the exact presentation the prescriber specifies.
What side effects should a hospital pharmacy know about before ordering phenytoin?
The UK SmPC states that phenytoin can cause severe cutaneous adverse reactions, which can be fatal. The US label says to discontinue at the first sign of a rash unless the rash is clearly not drug-related. The US label also says HLA-B*1502 may be a risk factor for SJS/TEN in patients of Asian ancestry, and that genotyping must never substitute for appropriate clinical vigilance. The injection label carries a boxed warning on cardiovascular risk with rapid infusion and describes purple glove syndrome. Both the US and UK labels state that phenytoin is a potent inducer of hepatic drug-metabolising enzymes, so interactions need checking. Read the full label before use.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.
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.
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