Active Pharmaceutical Ingredient

Lamotrigine API Manufacturer and Supplier in India

CAS: 84057-84-1 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Lamotrigine API Manufacturer and Supplier in India — Mediocon Inc
Lamotrigine API Manufacturer and Supplier in India

Product Overview

CAS No: 84057-84-1 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Lamotrigine is a synthetic phenyltriazine-class antiepileptic compound used as an anticonvulsant and mood-stabilizing pharmaceutical active ingredient. It is identified by CAS 84057-84-1, with molecular formula C₉H₇Cl₂N₅ and molecular weight 256.09 g/mol.

Lamotrigine API

Lamotrigine is a phenyltriazine derivative used in the management of epilepsy and for maintenance treatment of bipolar I disorder. It is a well-established pharmaceutical active ingredient with activity against abnormal neuronal electrical activity.

Chemical Information

Product Name: Lamotrigine
CAS Number: 84057-84-1
Molecular Formula: C₉H₇Cl₂N₅
Molecular Weight: 256.09 g/mol
Chemical Class: Phenyltriazine / Antiepileptic agent
IUPAC Name: 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine
PubChem CID: 3878
UNII: U3H27498KS
ChEBI ID: CHEBI:6367
DrugBank ID: DB00555

These chemical identity details are confirmed by PubChem and FDA records.

Mechanism of Action

Lamotrigine is believed to exert its anticonvulsant effects primarily by inhibiting voltage-sensitive sodium channels, thereby reducing the release of excitatory neurotransmitters and limiting abnormal neuronal activity.

The precise mechanism responsible for its therapeutic effects in bipolar disorder has not been fully established.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical and specialty chemical ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Lamotrigine quality evaluation may include identification, assay, chromatographic purity, related substances, residual solvents, water content, residue on ignition and other parameters according to the applicable product specification.

The exact analytical acceptance criteria should be confirmed against the current approved specification and batch-specific Certificate of Analysis.

Applications

Lamotrigine is used as an antiepileptic medicine for various seizure disorders and as a maintenance treatment for bipolar I disorder. Its exact approved indications and dosage forms should be confirmed according to the applicable regulatory authority and current prescribing information.

Product Characteristics

Lamotrigine is a white to pale cream-colored powder. FDA documentation reports a pKa of approximately 5.7. It is very slightly soluble in water, with reported solubility of approximately 0.17 mg/mL at 25°C.

Appearance: White to pale cream-colored powder

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and other documentation should be confirmed with MEDIOCON INC according to the intended application and customer requirements.

Product Specifications

Product NameLamotrigine API Manufacturer and Supplier in India
CAS Number84057-84-1
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to pale cream-colored powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to pale cream-colored powder

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Lamotrigine API Manufacturer and Supplier in India (CAS 84057-84-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lamotrigine API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Lamotrigine API Manufacturer and Supplier in India

What is Lamotrigine?
Lamotrigine is a phenyltriazine-class antiepileptic pharmaceutical active ingredient used as an anticonvulsant and mood stabilizer.
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