Agomelatine Tablets

Description

Agomelatine Film-Coated Tablets (25 mg)

Healthy Inc is a specialized global supplier and exporter of advanced CNS, psychiatry, and targeted neurological therapeutics. We provide ultra-high-purity, kinetically optimized Agomelatine Tablets, manufactured in WHO–GMP certified, high-precision specialized CNS facilities. This “Melatonergic (MT1/MT2) Agonist & 5-$HT_{2C}$ Antagonist” is a premium strategic export to mental health hospitals, sleep clinics, and government health ministries, serving as the globally preferred intervention for Major Depressive Episodes in adults.

Product Overview

This formulation operates as a “Bio-Clock Resynchronizer.” Agomelatine is chemically unique; it does not affect serotonin levels directly but instead repairs the broken sleep-wake cycles that often trigger or worsen depression.

• Mechanism 1 (Melatonergic Agonism): Agomelatine acts as a potent agonist at $MT_1$ and $MT_2$ receptors in the Suprachiasmatic Nucleus (the brain’s internal clock). This physically resynchronizes the circadian rhythm, improving sleep quality and daytime alertness.

• Mechanism 2 (Selective 5-$HT_{2C}$ Antagonism): By blocking the 5-$HT_{2C}$ serotonin receptors, Agomelatine triggers a localized release of Dopamine and Norepinephrine in the frontal cortex. This lifts the mood and energy levels without causing the systemic serotonin surges responsible for weight gain or sexual side effects.

• Mechanism 3 (The Tolerability Advantage): Because it lacks affinity for most other receptors (H1, alpha-1, or muscarinic), it is virtually free from the sedation, dry mouth, or blurred vision associated with older antidepressants.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Bioavailability Tablet, packed in high-barrier Alu-Alu blister strips to ensure the stability of the API.

Technical & Logistics Specifications

• HS Code: 3004.90.79 (Other medicaments acting on the CNS – Antidepressants)

• CAS Number: 138112-76-2 (Agomelatine)

• Dosage Form: Film-Coated Tablet

• Packaging: Alu-Alu Blisters. Protects the API from environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• API Purity Excellence: Our manufacturing process focuses on absolute chemical stability to ensure the MT1/MT2 selectivity remains exact, providing the predictable clinical response required for complex psychiatric cases.

• Neuro-Grade Containment: We utilize Segregated CNS Production Blocks to ensure zero cross-contamination, meeting the strictest international regulatory standards for psychiatric medications.

Primary Indications

• Psychiatry: Treatment of Major Depressive Episodes (MDE) in adults.

• Sleep Medicine: Management of depression-related insomnia and delayed sleep-phase syndrome.

• Specialist Care: First-line choice for patients who are sensitive to the sexual or metabolic side effects of SSRIs/SNRIs.

Dosage & Administration

• Standard Adult Dosing: 25 mg once daily, taken strictly at bedtime. If no improvement is seen after two weeks, the dose may be increased to 50 mg (two tablets).

• Administration: Can be taken with or without food.

Safety Warning: Hepatotoxicity. Agomelatine can cause increases in liver enzymes. MANDATORY: Liver function tests (LFTs) must be performed at initiation, and then at 3, 6, 12, and 24 weeks. Discontinue immediately if transaminases exceed 3x the upper limit of normal. Strictly contraindicated in patients with hepatic impairment (cirrhosis or active liver disease).

Global Export & Contract Manufacturing

Healthy Inc is a premier CNS Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for next-generation Melatonergic Antidepressants. Whether you are a Psychiatry Hospital Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.