Agomelatine Tablets 25mg

Agomelatine Tablets 25mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. A) Agomelatine Tablets 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. A) Agomelatine Tablets 25mg
   Each film coated tablet contains:
   Agomelatine IP…………………25mg
   Excipients ………………………………q.s.
   Colour: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

• Agomelatine is an antidepressant used to treat depression. The brain is usually good at making sure we have enough of the chemicals we need to function properly. But depression can affect a number of brain chemicals.

CAUTION &  WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
•  WARNING : NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A PSYCHIATRIST.

STORAGE & DOSAGE:

• Storage: Store below 30 °C.
  Protect from Light and moisture.
• Dosage: As directed by the psychiatrist.

Introduction to Agomelatine Tablets 25mg

Agomelatine Tablets 25mg belong to a modern class of antidepressant medicines primarily prescribed for the treatment of major depressive disorder (MDD) in adults. Depression is a persistent disturbance of mood that interferes with everyday life, affecting sleep, appetite, productivity, and emotional well-being. With increasing awareness of mental health and sleep disorders worldwide, the demand for effective and well-tolerated antidepressants like agomelatine is rising rapidly across global markets.

Agomelatine is unique because it acts as a melatonin receptor agonist (MT1 and MT2) and a serotonin (5-HT2C) antagonist, helping resynchronize the disturbed sleep-wake cycle commonly associated with depression. It is also used in the management of insomnia and jet lag, making it highly valuable in modern psychiatric therapy.

Taj Pharma, the well-known Agomelatine Tablets 25mg Manufacturer in India, assures international buyers of high quality, purity, and regulatory compliance. Manufactured at advanced facilities in Vapi, Gujarat, India, Taj Pharma supplies this critical antidepressant to domestic and international markets with consistent quality and reliable delivery.

  Uses and Therapeutic Benefits

Agomelatine Tablets 25mg are prescribed mainly for:

• Treatment of major depressive disorder in adults

• Management of sleep disturbances associated with depression

• Treatment of insomnia and circadian rhythm disorders

• Relief from jet lag-related sleep disruption

Unlike many conventional antidepressants, agomelatine does not typically cause sexual dysfunction or significant daytime sedation, making it a preferred option for long-term therapy under medical supervision.

Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter, and Supplier of Agomelatine Tablets 25mg from Vapi, Gujarat, ensuring international-grade formulations suitable for regulated and semi-regulated markets.

Why Global Demand for Agomelatine Tablets 25mg Is Growing

The global burden of depression and sleep disorders is increasing due to lifestyle changes, stress, and aging populations. Countries in Asia, Africa, the Middle East, Europe, and Latin America are witnessing rising prescriptions for melatonergic antidepressants.

Key drivers of demand include:

• Growing mental health awareness

• Preference for antidepressants with better sleep profile

• Increasing diagnosis of insomnia and depression

• Expansion of generic pharmaceutical markets

This has positioned India as a global hub, with Taj Pharma emerging as a Leading #1 Agomelatine Tablets 25mg Manufacturer & Supplier in India.

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma supports global buyers with complete regulatory and technical documentation, including:

• WHO-GMP Certificates

• EU-GMP (subject to market requirements)

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Stability Data

• CTD / ACTD Dossier support

• MSDS & Free Sale Certificate

Custom Packaging & Labeling

As a professional Agomelatine Tablets 25mg Exporter from India, Taj Pharma offers:

• Alu-Alu / Blister / Strip packaging

• Customized carton design

• Multilingual labeling as per importing country norms

• Private label & contract manufacturing support

Shelf-Life, Storage & Dosage Form

• Dosage Form: Film-coated tablet

• Strength: 25 mg

• Shelf Life: 24–36 months

• Storage: Store below 25°C, protected from light and moisture

Export Certifications

Taj Pharma complies with international standards such as:

• WHO-GMP

• ISO Certifications

• COPP

• CTD / Dossier support for product registration

Target Export Countries & Markets

Taj Pharma exports Agomelatine Tablets 25mg to:

• Africa

• Southeast Asia

• CIS Countries

• Middle East

• Latin America

• Select European and Asian markets

Why Taj Pharma Is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma operates advanced WHO-GMP certified manufacturing units in Vapi, Gujarat, equipped with:

• Automated production lines

• In-house quality control labs

• Strict pharmacovigilance systems

Affordable Pricing with Quality Assurance

As a top Agomelatine Tablets 25mg Manufacturer Supplier in India, Taj Pharma delivers:

• Competitive export pricing

• Consistent batch-to-batch quality

• Compliance with pharmacopeial standards

Global Presence & Supply Chain Support

• Strong logistics network

• On-time international shipments

• Regulatory assistance for new market entry

Top 20 Countries Exported To

India , Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines, Cambodia, Nigeria, Kenya, Ghana, Egypt, Ethiopia, Morocco, Peru, Colombia, Ecuador, Bolivia , Ukraine, Uzbekistan, Kazakhstan

Technical Product Specification  

Safety Profile & Side Effects

Most side effects of Agomelatine Tablets 25mg do not require medical attention and disappear as the body adjusts to the medicine. However, patients should consult a doctor if symptoms persist.

Common side effects include:

• Headache

• Dizziness

• Fatigue

• Anxiety

• Insomnia or sleepiness

• Increased liver enzymes

• Abnormal dreams

• Gastrointestinal disturbances

• Weight gain

You have been prescribed agomelatine for the treatment of depression. It may take a few weeks to start working. Continue taking it as prescribed.

Top 20 FAQs  

1. What is Agomelatine Tablets 25mg used for?
   Used to treat depression and sleep disorders in adults.

2. Is Taj Pharma a WHO-GMP manufacturer?
   Yes, Taj Pharma is a WHO-GMP certified manufacturer in India.

3. Can Agomelatine be exported from India?
   Yes, Taj Pharma exports globally with full documentation.

4. What is the shelf life?
   24–36 months.

5. Does Taj Pharma offer private labeling?
   Yes, private labeling and contract manufacturing are available.

6. Is agomelatine safe for long-term use?
   Yes, under medical supervision.

7. Does it cause dependence?
   No, agomelatine is non-habit forming.

8. What packaging options are available?
   Blister and Alu-Alu packs.

9. Is it suitable for insomnia?
   Yes, especially insomnia linked to depression.

10. Does it affect sexual function?
    Minimal impact compared to other antidepressants.

11. Is liver monitoring required?
    Yes, periodic liver function tests are advised.

12. Can Taj Pharma supply bulk quantities?
    Yes, bulk and large export orders are supported.

13. What countries does Taj Pharma export to?
    Over 20 countries worldwide.

14. Is it prescription-only?
    Yes, prescription medicine.

15. Can Taj Pharma support product registration?
    Yes, CTD and regulatory support available.

16. Is it effective for jet lag?
    Yes, due to melatonin receptor activity.

17. What is the usual dosage?
    25 mg once daily as prescribed.

18. Where is Taj Pharma located?
    Vapi, Gujarat, India.

19. Does Taj Pharma provide COA?
    Yes, COA is provided with every batch.

20. Why choose Taj Pharma?
    Quality, compliance, affordability, and global trust.

Call to Action 

If you are looking for a reliable Agomelatine Tablets 25mg Manufacturer in India, trusted by global buyers, Taj Pharma is your ideal partner. With WHO-GMP certified manufacturing, competitive pricing, and complete export support, Taj Pharma ensures long-term success for distributors, importers, and PCD franchise partners worldwide.