Agomelatine Tablets 25mg

Agomelatine Tablets 25mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Agomelatine Tablets 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Agomelatine Tablets 25mg
Each film coated tablet contains:
Agomelatine…………………….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: To be sold by retail on the prescription of a psychiatrist only.

STORAGE & DOSAGE:

Storage: Store the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the psychiatrist.

Attach dispensing label as per end country.

Introduction to Agomelatine Tablets 25mg

Agomelatine Tablets 25mg is a modern antidepressant used to treat depression by regulating brain chemicals such as serotonin, dopamine, and noradrenaline. These neurotransmitters play a vital role in mood, motivation, and overall mental well-being. In depression, imbalances in these chemicals can lead to persistent sadness, lack of interest, and other psychological symptoms.

Agomelatine works uniquely as a melatonergic antidepressant, targeting melatonin receptors in the brain, helping regulate circadian rhythms and improve sleep patterns, while simultaneously modulating neurotransmitters to alleviate depressive symptoms.

Globally, the demand for Agomelatine Tablets 25mg has increased due to rising mental health awareness, improved diagnostic rates, and growing acceptance of pharmacological interventions for depression. Taj Pharma, a trusted Agomelatine Tablets 25mg manufacturer in India, caters to this global demand, providing high-quality, safe, and effective medication for international buyers.

In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma ensures a comprehensive support system for international importers and distributors of Agomelatine Tablets 25mg, including regulatory, packaging, and logistical services.

Regulatory Documentation Provided

• WHO-GMP and EU-GMP certifications

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier for international submissions

• Free Sale Certificates for global markets

• Compliance with FDA, MHRA, and TGA standards for export

Custom Packaging & Labeling

• Blister packs, bottles, and alu-alu packaging available

• Private labeling and custom branding for distributors

• Packaging ensures tablet integrity, shelf-life, and safety

Shelf-Life, Storage & Dosage Form

• Shelf-life: 24–36 months

• Storage: Store in a cool, dry place, away from direct sunlight

• Dosage Form: Oral tablets – 25mg

Export Certifications

• WHO-GMP and EU-GMP approved manufacturing

• ISO 9001:2015 certification

• Stability and quality control reports for each batch

• CTD dossier submission for international regulatory approvals

Target Countries & Export Markets

Taj Pharma exports Agomelatine Tablets 25mg to over 70 countries, including:

• Africa: Nigeria, Kenya, Ghana, South Africa

• Asia-Pacific: Philippines, Vietnam, Myanmar, Bangladesh

• Middle East: UAE, Saudi Arabia, Iraq, Oman

• Europe: Romania, Poland, Bulgaria, Germany

• Latin America: Brazil, Mexico, Argentina

This ensures timely and reliable delivery for all global buyers.

Why is the Most Trusted Manufacturer/Supplier/Exporter

Taj Pharma has earned global trust in the pharmaceutical industry for producing Agomelatine Tablets 25mg.

State-of-the-Art Manufacturing

• WHO-GMP and EU-GMP certified facility in Vapi, Gujarat

• Advanced automated production lines

• Strict QA/QC protocols ensuring purity, safety, and potency

Affordable Pricing & Quality Assurance

• Cost-effective solutions for bulk orders

• High-quality raw materials sourced from certified suppliers

• Strict compliance with global pharmacopoeia standards

Global Presence & Supply Chain Support

• Exporting to over 70 countries worldwide

• End-to-end logistics and customs support

• Assistance with regulatory approvals and documentation

Top 20 Countries Exporting

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

Call to Action for Buyers/Distributors

For importers, distributors, and PCD pharma franchise partners seeking a reliable source of Agomelatine Tablets 25mg, Taj Pharma offers:

• WHO-GMP certified manufacturing

• International regulatory compliance

• Custom packaging and labeling

• Competitive pricing for bulk orders

📞 Contact Taj Pharma today to secure high-quality, certified, and effective Agomelatine Tablets 25mg for your business.

Top 20 FAQs 

Q1. What is Agomelatine Tablets 25mg used for?
It is used to treat major depressive disorder and improve sleep patterns.

Q2. Who is the leading manufacturer in India?
Taj Pharma is a trusted Agomelatine Tablets 25mg manufacturer in India.

Q3. How does Agomelatine work?
It regulates melatonin receptors and neurotransmitters like serotonin to alleviate depression.

Q4. Can it be exported globally?
Yes, Taj Pharma exports to over 70 countries worldwide.

Q5. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO, COPP, and CTD dossiers.

Q6. What is the shelf-life?
24–36 months depending on storage conditions.

Q7. Is private labeling available?
Yes, custom packaging and branding services are provided.

Q8. Common side effects?
Headache, dizziness, fatigue, anxiety, insomnia, increased liver enzymes.

Q9. Can it cause sleepiness or dizziness?
Yes, avoid driving or operating machinery until effects are known.

Q10. Can it be taken by pregnant women?
Consult your doctor before using during pregnancy or breastfeeding.

Q11. Storage conditions?
Store in a cool, dry place away from sunlight.

Q12. Dosage form?
Oral tablets of 25mg strength.

Q13. How long does it take to work?
It may take a few weeks for noticeable improvement.

Q14. Is it suitable for long-term use?
Yes, under medical supervision and periodic liver function monitoring.

Q15. Is PCD Pharma Franchise available?
Yes, Taj Pharma provides franchise opportunities nationwide.

Q16. Where is Taj Pharma located?
Vapi, Gujarat, India.

Q17. Can it interact with other medications?
Yes, inform your doctor about all medicines being taken.

Q18. Can alcohol affect its action?
Alcohol may worsen side effects; avoid or limit consumption.

Q19. How does Taj Pharma ensure quality?
Through GMP-approved facilities, QA/QC checks, and international audits.

Q20. Why choose Taj Pharma over other suppliers?
Taj Pharma combines quality, affordability, certifications, and global trust, making it a reliable choice for buyers worldwide.