LAMOTRIGINE

Lamotrigine API is a well-established anticonvulsant and mood stabilizer widely used in the management of epilepsy and bipolar disorder. It belongs to the phenyltriazine class and is highly effective in controlling partial and generalized seizures, as well as preventing mood episodes in patients with bipolar disorder.

At Bluepill Express, we specialize in the large-scale manufacturing and export of pharmaceutical-grade Lamotrigine API. Produced under WHO-GMP, ISO 9001:2015, and cGMP certified facilities, our Lamotrigine meets USP / BP / IP / EP specifications and is available with complete COA, MSDS, and DMF documentation.

Lamotrigine acts primarily by stabilizing neuronal membranes and inhibiting voltage-sensitive sodium channels, which reduces excessive neuronal firing — the underlying cause of seizures and mood fluctuations. It also decreases the release of excitatory neurotransmitters such as glutamate and aspartate, ensuring controlled mood balance and seizure prevention.

Bluepill Express ensures exceptional purity, precise particle size distribution, and consistent assay across every batch, making it a reliable choice for global pharmaceutical companies and formulation developers.

Therapeutic Applications:

• Epilepsy (Partial and Generalized Seizures)
• Lennox–Gastaut Syndrome
• Bipolar I Disorder (Maintenance Therapy)
• Mood Stabilization in Depressive Episodes
• Adjunct Therapy in Seizure Disorders

Mechanism of Action:

Lamotrigine inhibits voltage-gated sodium channels in the presynaptic neurons, stabilizing neuronal membranes and decreasing the release of excitatory neurotransmitters such as glutamate and aspartate.
This dual effect contributes to both antiepileptic and mood-stabilizing actions, making it highly effective for long-term management of neurological and psychiatric conditions.

Technical Specifications:

• Chemical Name: Lamotrigine
• Molecular Formula: C₉H₇Cl₂N₅
• Molecular Weight: 256.09 g/mol
• CAS Number: 84057-84-1
• Description: White to off-white crystalline powder
• Assay (on dried basis): NLT 99.0%
• Melting Point: 216°C – 218°C
• Solubility: Slightly soluble in water; soluble in dimethylformamide and methanol
• pKa: 5.7
• Storage: Store below 25°C in a cool, dry place protected from light and moisture

Pharmacological Classification

• Therapeutic Class: Antiepileptic / Mood Stabilizer
• Pharmacopoeial Standards: USP / BP / IP / EP
• Dosage Form Applications:
  • Tablets (25 mg, 50 mg, 100 mg, 200 mg)
  • Dispersible Tablets
  • Chewable and Oral Suspensions

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured under WHO-GMP, ISO, and cGMP certifications
• Fully compliant with USP / BP / IP / EP standards
• Advanced HPLC and UV spectroscopy testing for purity and assay
• Low impurity profile and consistent batch reproducibility
• Full documentation: COA, MSDS, DMF (on request)
• Micronized grades available for specific formulation requirements

Advantages of Bluepill Express Lamotrigine API:

• High assay purity (≥99%)
• Consistent bioavailability and dissolution profile
• Suitable for global formulation and export
• Customizable packaging and labeling options
• Regulatory support for DMF submission and registration

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drum with double LDPE liner
• Labeling: In compliance with international export and regulatory norms
• Shelf Life: 3 years under recommended storage
• Export Markets: Africa, Asia-Pacific, Middle East, Europe, and Latin America
• Documents Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF) – available on request
  • BSE/TSE and Non-GMO declarations