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Lamotrigine API Manufacturers & Suppliers

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Commercial-scale Suppliers

Producer
Produced in  Poland
|

Employees: 455+

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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CEP
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USDMF
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EDMF/ASMF

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BSE/TSE
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CoA
Producer
Produced in  India
|

Employees: 10k+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CEP
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USDMF
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MSDS
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BSE/TSE

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CEP
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MSDS
BSE/TSE
ISO9001
CoA
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Distributor
Produced in  India
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Employees: 10

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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CoA

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MSDS
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CoA
Distributor
Produced in  Singapore
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Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CEP
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USDMF
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EDMF/ASMF

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CoA
Distributor
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
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FDA
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MSDS
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CoA

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MSDS
CoA
Distributor
Produced in  World
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Employees: +250

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
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Distributor
Produced in  India
|

Employees: 25

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
MSDS
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BSE/TSE
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ISO9001

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GMP
FDA
MSDS
BSE/TSE
ISO9001
CoA
Producer
Produced in  India
|

Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CoA

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GMP
FDA
CoA
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Producer
Produced in  Hungary
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

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GMP
CoA
Producer
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
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WC
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CoA

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WC
CoA
Producer
Produced in  Taiwan
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Certifications: USDMF
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JDMF
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CoA

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JDMF
CoA
Producer
Produced in  Spain
|

Employees: 80+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
|
MSDS
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BSE/TSE
|
ISO

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GMP
USDMF
MSDS
BSE/TSE
ISO
WHO-GMP
CoA
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Producer
Produced in  India
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WC
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CoA

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GMP
WC
CoA
Producer
Produced in  India
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USDMF
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WC
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CoA

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USDMF
WC
CoA
Producer
Produced in  India
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FDA
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CEP
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coa
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WC

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CEP
coa
WC
Producer
Produced in  India
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USDMF
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WC

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WC
coa
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Produced in  China
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CoA
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WC

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CoA
WC
Producer
Produced in  Unknown
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coa

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coa
WC
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Producer
Produced in  India
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CoA

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CoA
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Producer
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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ISO
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coa
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ISO 9001

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GMP
FDA
ISO
coa
ISO 9001
WC
Not active
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Producer
Produced in  India
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Certifications: USDMF
|
CoA

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USDMF
CoA
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Producer
Produced in  India
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USDMF
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CoA
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WC

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USDMF
CoA
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Produced in  Unknown
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CoA

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CoA
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Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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WC
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CoA

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GMP
WC
CoA
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Lamotrigine | CAS No: 84057-84-1 | GMP-certified suppliers

A medication that supports control of partial and generalized seizures, including Lennox‑Gastaut syndrome, and helps maintain stability in bipolar I disorder.

Therapeutic categories

Agents causing hyperkalemiaAgents producing tachycardiaAnti-epileptic AgentAntiarrhythmic agentsAnticholinergic AgentsAnticonvulsants
Generic name
Lamotrigine
Molecule type
small molecule
CAS number
84057-84-1
DrugBank ID
DB00555
Approval status
Approved drug, Investigational drug
ATC code
N03AX09

Primary indications

  • Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: partial seizures, primary generalized tonic-clonic seizures, and generalized seizures due to Lennox-Gastaut syndrome
  • It is also indicated for the process of conversion to drug monotherapy for those at least 16 years of age or older with partial seizures and currently are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED)

Product Snapshot

  • Lamotrigine is an oral small‑molecule API supplied primarily in multiple tablet presentations, including immediate‑release, chewable/dispersible, soluble, and extended‑release forms
  • It is used for epilepsy management across several seizure types and for maintenance treatment of bipolar I disorder
  • It is approved in the US and Canada, with both approved and investigational statuses noted for specific formulations

Clinical Overview

Lamotrigine (CAS 84057-84-1) is a phenyltriazine antiepileptic agent used globally for management of epilepsy and for maintenance treatment in bipolar I disorder. It is indicated as adjunctive therapy for partial seizures, primary generalized tonic‑clonic seizures, and generalized seizures associated with Lennox‑Gastaut syndrome in patients two years and older. It is also used for conversion to monotherapy in eligible adults with partial seizures. In bipolar I disorder, lamotrigine is approved to delay recurrence of mood episodes after stabilization with standard acute‑phase therapy. It is not indicated for treatment of acute mania or acute bipolar depression.

Lamotrigine exerts antiseizure and mood‑stabilizing effects primarily through inhibition of voltage‑sensitive sodium channels, promoting stabilization of presynaptic neuronal membranes and reducing pathologic glutamate release. Its pharmacologic profile also includes weak affinity for several neurotransmitter receptors at high micromolar concentrations, along with evidence for inhibition of R‑type calcium currents, which may contribute to its anticonvulsant activity.

Absorption following oral administration is generally efficient, and lamotrigine undergoes predominant hepatic glucuronidation with renal elimination of metabolites. Conditions that reduce glucuronidation, such as hepatic impairment or coadministration with valproate, increase systemic exposure. Enzyme‑inducing antiepileptic drugs enhance clearance. The drug’s 2‑N‑methyl metabolite can prolong PR and QRS intervals at high concentrations; although typically present at trace levels, accumulation is possible in impaired metabolism.

Safety considerations include risk of severe cutaneous adverse reactions, particularly with rapid dose escalation or concomitant valproate. Central nervous system effects such as dizziness or diplopia are dose related. Cardiovascular conduction effects are uncommon but clinically relevant in susceptible populations.

Lamotrigine is marketed in many regions as immediate‑release and extended‑release formulations. When procuring the active pharmaceutical ingredient, sourcing teams should verify compliance with current pharmacopoeial specifications, control of polymorphic form, and confirmed impurity profiles supporting consistent glucuronidation pathways and stability.

Identification & chemistry

Generic name Lamotrigine
Molecule type Small molecule
CAS 84057-84-1
UNII U3H27498KS
DrugBank ID DB00555

Pharmacology

SummaryLamotrigine primarily modulates neuronal excitability by inhibiting voltage‑gated sodium channels, stabilizing presynaptic membranes, and reducing glutamate release. It also exhibits weaker interactions with multiple receptor families and may inhibit R‑type calcium currents, contributing to its anticonvulsant and mood‑stabilizing effects. Minor metabolites have been associated with cardiac conduction effects, though these are typically present at low levels under normal metabolic conditions.
Mechanism of actionThe exact mechanism of action of lamotrigine is not fully elucidated, as it may exert cellular activities that contribute to its efficacy in a range of conditions. Although chemically unrelated, lamotrigine actions resemble those of phenytoin and carbamazepine, inhibiting voltage-sensitive sodium channels, stabilizing neuronal membranes, thereby modulating the release of presynaptic excitatory neurotransmitters. Lamotrigine likely acts by inhibiting sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate. The mechanism of action of lamotrigine in reducing anticonvulsant activity is likely the same in managing bipolar disorder. Studies on lamotrigine have identified its binding to sodium channels in a fashion similar to local anesthetics, which could explain the demonstrated clinical benefit of lamotrigine in some neuropathic pain states. Lamotrigine displays binding properties to several different receptors. In laboratory binding assays, it demonstrates weak inhibitory effect on the serotonin 5-HT3 receptor. Lamotrigine also weakly binds to Adenosine A1/A2 receptors, α1/α2/β adrenergic receptors, dopamine D1/D2 receptors, GABA A/B receptors, histamine H1 receptors, κ-opioid receptor (KOR), mACh receptors and serotonin 5-HT2 receptors with an IC50>100 µM. Weak inhibitory effects were observed at sigma opioid receptors.An in vivo study revealed evidence that lamotrigine inhibits Cav2.3 (R-type) calcium currents, which may also contribute to its anticonvulsant effects.
PharmacodynamicsLamotrigine likely prevents seizures and prevents mood symptoms via stabilizing presynaptic neuronal membranes and preventing the release of excitatory neurotransmitters such as glutamate, which contribute to seizure activity. A note on cardiovascular effects The metabolite of lamotrigine, 2-N-methyl metabolite (formed by glucuronidation), is reported to cause dose-dependent prolongations of the PR interval, widening of the QRS complex, and at higher doses, complete AV block. Although this harmful metabolite is only found in trace amounts in humans, plasma concentrations may increase in conditions that cause decreased drug glucuronidation, such as liver disease.
Targets
TargetOrganismActions
Voltage-dependent R-type calcium channel subunit alpha-1E (CACNA1E)Humansinhibitor
Voltage-gated sodium channel alpha subunitHumansinhibitor
Adenosine receptor A1Humansinhibitor

ADME / PK

AbsorptionLamotrigine is rapidly and entirely absorbed with minimal first-pass metabolism effects, with a bioavailability estimated at 98%. Cmax is reached in the range of 1.4 to 4.8 hours post-dose, but this depends on the dose administered, concomitant medications, and epileptic status. The rate and extent of lamictal absorption is considered equivalent between the compressed tablet form taken with water to that of the chewable dispersible tablets, taken with or without water.
Half-lifeThe average elimination half-life of lamotrigine ranges from approximately 14-59 hours. The value is dependent on the dose administered, concomitant drug therapy, as well as disease status.One pharmacokinetic study revealed a half-life of 22.8 to 37.4 hours in healthy volunteers. It also reported that enzyme-inducing antiepileptic drugs such as pheobarbital, phenytoin, or carbamazepine decrease the half-life of lamotrigine. On the other hand, valproic acid increases the half-life of lamotrigine (in the range of 48-59 hours).
Protein bindingThe plasma protein binding of lamotrigine is estimated at 55%.This drug is not expected to undergo clinically significant interactions with other drugs via competition for protein binding sites due its lower protein binding.
MetabolismLamotrigine is mainly glucuronidated, forming 2-N-glucuronide conjugate, a pharmacologically inactive metabolite.The total radioactivity detected after a 240mg radiolabeled dose of lamotrigine during clinical trials were as follows: lamotrigine as unchanged drug(10%), a 2-N-glucuronide (76%), a 5-N-glucuronide (10%), a 2-N-methyl metabolite (0.14%), as well as various other minor metabolites (4%).
Route of eliminationLamotrigine is excreted in both the urine and feces.Following oral administration of 240 mg radiolabelled lamotrigine, about 94% of total drug and its metabolites administered is recovered in the urine and 2% is recovered in the feces.One pharmacokinetic study recovered 43 to 87% of a lamotrigine dose in the urine mainly as glucuronidated metabolites.2-N-glucuronide is mainly excreted in the urine.
Volume of distributionThe mean apparent volume of distribution (Vd/F) of lamotrigine following oral administration ranges from 0.9 to 1.3 L/kg and is independent of dose administered. Lamotrigine accumulated in the kidney of the male rat, and likely behaves in a similar fashion in humans. Lamotrigine also binds to tissues containing melanin, such as the eyes and pigmented skin.
ClearanceThe mean apparent plasma clearance (Cl/F) ranges from 0.18 to 1.21 mL/min/kg. The values vary depending on dosing regimen, concomitant antiepileptic medications, and disease state of the individual.In one study, healthy volunteers on lamictal monotherapy showed a clearance of about 0.44 mL/min/kg after a single dose.

Formulation & handling

  • Oral small‑molecule API with moderate lipophilicity and low aqueous solubility, requiring solubilization or dispersibility strategies for suspension and ODT/chewable formats.
  • Stable solid suitable for conventional and extended‑release tablets; ER performance depends on controlling its pH‑independent absorption and dissolution‑rate limitations.
  • No food‑related absorption impact, allowing flexible administration without special formulation adjustments for fed‑state variability.

Regulatory status

LifecycleMost early Canadian and U.S. patent protection for the API expired in 2012, but several U.S. patents remain active through 2028. As a result, the product is generally mature in Canada while portions of the U.S. market remain under later‑expiring exclusivities.
MarketsCanada, US
Supply Chain
Supply chain summaryLamotrigine’s supply landscape is mature, with an originator lineage from GlaxoSmithKline and extensive participation by numerous generic manufacturers and repackagers supporting large‑scale distribution. Branded and generic products are widely available in the US and Canada, reflecting well‑established global market penetration. Core substance patents expired more than a decade ago, and although some later‑filed US patents extend into the late 2020s, the market already supports broad generic competition.

Safety

ToxicityThe oral LD50 in mouse and rat is 205 mg/kg and 245 mg/kg, respectively.[MSDS] Fatal cases of overdose of up to 15g of lamotrigine have been reported. Overdose with lamotrigine has been manifested by ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay. Though no known antidote exists for lamotrigine, hospitalization and general supportive measures should be employed in the case of a suspected lamotrigine overdose. Gastric lavage and emesis may be warranted with simultaneous protection of the airway. It is uncertain at this time whether hemodialysis is an effective means of removing lamotrigine from the sytemic circulation.
High Level Warnings:
  • Acute toxicity is moderate, with reported oral LD50 values of 205 mg/kg (mouse) and 245 mg/kg (rat), indicating a defined hazard profile at relatively low gram‑scale exposures
  • Documented overdose cases (up to ~15 g) have resulted in CNS depression, ataxia, nystagmus, seizure exacerbation, coma, and intraventricular conduction delay, underscoring the compound’s narrow safety margin at high systemic levels
  • No specific antidote is identified

Lamotrigine is a type of Anticonvulsants


Anticonvulsants are a vital category of pharmaceutical Active Pharmaceutical Ingredients (APIs) used for the treatment of seizures and epilepsy. These APIs play a crucial role in managing and preventing convulsions, which are characterized by abnormal electrical activity in the brain. With a significant demand for effective anticonvulsant medications, these APIs hold immense importance in the pharmaceutical industry.

Anticonvulsant APIs work by stabilizing the excessive electrical activity in the brain, preventing or reducing seizures. They achieve this by targeting specific receptors or channels involved in the regulation of neuronal excitability. Some commonly used anticonvulsant APIs include phenytoin, valproic acid, carbamazepine, and lamotrigine.

Pharmaceutical companies utilize these APIs to formulate various dosage forms, such as tablets, capsules, and oral suspensions, ensuring convenient administration for patients. Additionally, anticonvulsant APIs may also be employed in the development of extended-release formulations, providing sustained and controlled drug release.

The market for anticonvulsant APIs continues to grow due to the rising prevalence of epilepsy and other seizure disorders. Moreover, ongoing research and development efforts aim to enhance the efficacy, safety, and tolerability of these APIs, ensuring better treatment outcomes for patients.

In conclusion, anticonvulsant APIs are a crucial pharmaceutical category used to manage seizures and epilepsy. With their ability to stabilize brain activity, these APIs play a pivotal role in improving the quality of life for individuals living with these conditions. The pharmaceutical industry's continued focus on research and development in this area ensures the availability of advanced and effective anticonvulsant medications for patients in need.

Lamotrigine API manufacturers & distributors

Compare qualified Lamotrigine API suppliers worldwide. We currently have 24 companies offering Lamotrigine API, with manufacturing taking place in 9 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Distributor
Singapore Singapore BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC200 products
Producer
India Unknown CEP, CoA, FDA, GMP, USDMF, WC164 products
Producer
India India CoA, FDA, GMP, ISO9001, Other, WC47 products
Producer
Hungary Hungary CoA, GMP48 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
India India CEP, CoA, FDA, GMP, WC10 products
Producer
India India CoA, GMP69 products
Producer
India India BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF52 products
Distributor
India India CoA, FDA, GMP, MSDS17 products
Producer
India India CoA, USDMF155 products
Producer
Spain Unknown CoA, USDMF39 products
Producer
Spain Spain BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP15 products
Producer
India India CEP, CoA, USDMF, WC201 products
Producer
Poland Poland BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF64 products
Producer
India India CoA, GMP, WC3 products
Producer
India India CoA, GMP, WC13 products
Distributor
Jordan World CoA, GMP70 products
Producer
India India CoA, FDA, GMP515 products
Producer
India India CoA, GMP, WC219 products
Producer
Taiwan Taiwan CoA, JDMF, USDMF22 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, MSDS263 products
Producer
India India CoA, GMP, USDMF, WC34 products
Producer
India India CEP, CoA, FDA, GMP, USDMF, WC62 products
Producer
China China CoA, USDMF, WC13 products

When sending a request, specify which Lamotrigine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Lamotrigine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Lamotrigine API


Sourcing

What matters most when sourcing GMP-grade Lamotrigine?
Prioritize GMP compliance with supporting quality documentation suitable for US and Canadian regulatory expectations. Verify the manufacturer’s ability to provide consistent batch quality and traceability, given the broad generic participation in the market. Assess supply reliability and change‑control practices to ensure continuity within a mature, multi‑source supply landscape.
Which documents are typically required when sourcing Lamotrigine API?
Request the core API documentation set: CoA (23 companies), GMP (18 companies), USDMF (12 companies), WC (11 companies), FDA (9 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Lamotrigine API?
Known or reported manufacturers for Lamotrigine: Polpharma, SEDANAH, Global Pharma Tek, SETV Global, Apollo Healthcare Resources (Singapore), Tenatra Exports Private Limited, Jubilant Pharmova. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Lamotrigine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Lamotrigine manufacturers?
Audit reports may be requested for Lamotrigine: 9 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Lamotrigine API on Pharmaoffer?
Reported supplier count for Lamotrigine: 23 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Lamotrigine API?
Production countries reported for Lamotrigine: India (14 producers), Poland (1 producer), Singapore (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Lamotrigine usually hold?
Common certifications for Lamotrigine suppliers: CoA (23 companies), GMP (18 companies), USDMF (12 companies), WC (11 companies), FDA (9 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Lamotrigine (CAS 84057-84-1) used for?
Lamotrigine is used to manage epilepsy and for maintenance treatment of bipolar I disorder. In epilepsy, it is indicated as adjunctive therapy for partial seizures, primary generalized tonic‑clonic seizures, and seizures associated with Lennox‑Gastaut syndrome, and it can be used for conversion to monotherapy in eligible adults with partial seizures. In bipolar I disorder, it is approved to delay recurrence of mood episodes after stabilization with acute‑phase therapy.
Which therapeutic class does Lamotrigine fall into?
Lamotrigine belongs to the following therapeutic categories: Agents causing hyperkalemia, Agents producing tachycardia, Anti-epileptic Agent, Antiarrhythmic agents, Anticholinergic Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Lamotrigine mainly prescribed for?
The primary indications for Lamotrigine: Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: partial seizures, primary generalized tonic-clonic seizures, and generalized seizures due to Lennox-Gastaut syndrome, It is also indicated for the process of conversion to drug monotherapy for those at least 16 years of age or older with partial seizures and currently are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Lamotrigine work?
The exact mechanism of action of Lamotrigine is not fully elucidated, as it may exert cellular activities that contribute to its efficacy in a range of conditions. Although chemically unrelated, Lamotrigine actions resemble those of phenytoin and carbamazepine, inhibiting voltage-sensitive sodium channels, stabilizing neuronal membranes, thereby modulating the release of presynaptic excitatory neurotransmitters. Lamotrigine likely acts by inhibiting sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate. The mechanism of action of Lamotrigine in reducing anticonvulsant activity is likely the same in managing bipolar disorder. Studies on Lamotrigine have identified its binding to sodium channels in a fashion similar to local anesthetics, which could explain the demonstrated clinical benefit of Lamotrigine in some neuropathic pain states. Lamotrigine displays binding properties to several different receptors. In laboratory binding assays, it demonstrates weak inhibitory effect on the serotonin 5-HT3 receptor. Lamotrigine also weakly binds to Adenosine A1/A2 receptors, α1/α2/β adrenergic receptors, dopamine D1/D2 receptors, GABA A/B receptors, histamine H1 receptors, κ-opioid receptor (KOR), mACh receptors and serotonin 5-HT2 receptors with an IC50>100 µM. Weak inhibitory effects were observed at sigma opioid receptors.An in vivo study revealed evidence that Lamotrigine inhibits Cav2.3 (R-type) calcium currents, which may also contribute to its anticonvulsant effects.
What should someone know about the safety or toxicity profile of Lamotrigine?
Lamotrigine has a moderate acute toxicity, with oral LD50 values of 205 mg/kg in mice and 245 mg/kg in rats. Overdose cases up to about 15 g have produced CNS depression, ataxia, nystagmus, seizure worsening, coma, and intraventricular conduction delay, and no specific antidote is available. Clinically, severe cutaneous reactions are a key risk, especially with rapid titration or concomitant valproate, and dose‑related CNS effects such as dizziness or diplopia may occur. Cardiovascular conduction changes are uncommon but can appear in susceptible individuals or with metabolite accumulation when clearance is reduced.
What are important formulation and handling considerations for Lamotrigine as an API?
Important considerations include addressing its low aqueous solubility by using solubilization or dispersibility strategies, particularly for suspensions and orally disintegrating or chewable formats. The API is a stable solid suitable for immediate‑ and extended‑release tablets, with ER performance dependent on controlling dissolution rate due to its pH‑independent absorption. Its high bioavailability and lack of food‑effect simplify oral formulation design. Standard handling of a solid oral API applies.
Is Lamotrigine a small molecule?
Lamotrigine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Lamotrigine?
Oral Lamotrigine is a stable solid and does not present unusual stability concerns in conventional or extended‑release tablet formats. Its low aqueous solubility mainly affects formulation design for suspensions and orally disintegrating or chewable forms, where solubilization or dispersibility strategies are needed. Extended‑release performance depends on maintaining controlled dissolution due to its pH‑independent absorption. No food‑related effects on absorption introduce additional stability or formulation constraints.

Regulatory

Where is Lamotrigine approved or in use globally?
Lamotrigine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Lamotrigine right now?
Lamotrigine is regulated for use in both Canada and the United States, where it is subject to standard national requirements for quality, safety, and labeling. Patent coverage depends on the specific formulation or product and follows each country’s established intellectual‑property framework, with protections defined by individual filings and expiry timelines.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Lamotrigine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Lamotrigine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Lamotrigine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Lamotrigine: 3012 verified transactions across 593 suppliers and 289 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Lamotrigine?
Market report availability for Lamotrigine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.