Lamotrigine Tablets 50mg

Lamotrigine Tablets 50mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Lamotrigine Tablets USP 25mg
• Lamotrigine Tablets USP 50mg
• Lamotrigine Tablets USP 100mg
  
• Lamotrigine Tablets USP 150mg
• Lamotrigine Tablets USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Lamotrigine Tablets USP 25mg
  Each uncoated tablet contains:|
  Lamotrigine USP……………….25mg
  |Excipients………………………………q.s.
• b) Lamotrigine Tablets USP 50mg
  Each uncoated tablet contains:
  Lamotrigine USP……………….50mg
  Excipients………………………………q.s.
• c) Lamotrigine Tablets USP 100mg
  Each uncoated tablet contains:
  Lamotrigine USP……………….100mg
  Excipients………………………………q.s.
• d) Lamotrigine Tablets USP 150mg
  Each uncoated tablet contains:
  Lamotrigine USP……………….150mg
  Excipients………………………………q.s.
• e) Lamotrigine Tablets USP 200mg
  Each uncoated tablet contains:
  Lamotrigine USP……………….200mg
  Excipients………………………………q.s.

THERAPEUTIC INDICATIONS:

• Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug.

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
• Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

• Storage:  Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
• Dosage:  As directed by the Physician.

Introduction to Lamotrigine Tablets 50mg

Lamotrigine Tablets 50mg are a vital medication in the management of epilepsy and bipolar disorder. This drug works by stabilizing electrical activity in the brain, helping to control seizures, including partial seizures, tonic-clonic seizures, and Lennox-Gastaut syndrome. Though not a cure for epilepsy, Lamotrigine provides long-term relief by reducing seizure frequency and intensity, thereby improving patients’ quality of life.

Globally, the demand for Lamotrigine Tablets is rising due to increasing cases of epilepsy, mood disorders, and neurological conditions. According to WHO, epilepsy affects more than 50 million people worldwide, and bipolar disorder impacts millions more. Hence, high-quality and affordable Lamotrigine is essential for both domestic treatment programs and international healthcare systems.

This demand has positioned Taj Pharma as a leading Lamotrigine Tablets 50mg manufacturer in India, trusted by doctors, distributors, and global buyers for quality, efficacy, and compliance.

In-depth Details for Importers, Exporters & Buyers

For global distributors, procurement managers, and government healthcare buyers, regulatory compliance and product reliability are critical. Taj Pharma addresses these with unmatched professionalism.

1. Regulatory Documentation Provided

Taj Pharma supplies a complete set of documentation with every Lamotrigine Tablets 50mg export from India, including:

• WHO-GMP / EU-GMP certification

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier (Common Technical Document)

• COA (Certificate of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability and Bioequivalence Data (if required)

This ensures hassle-free registration in regulated and semi-regulated markets worldwide.

2. Custom Packaging & Labeling

Taj Pharma offers buyer-specific packaging solutions, such as:

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

• Multi-language labels compliant with country-specific regulations

• Temperature and moisture-protected cartons for export logistics

• Branding options for PCD pharma franchise partners

3. Shelf-life, Storage & Dosage Form

• Dosage form: Oral tablets (50mg strength)

• Shelf-life: 24–36 months depending on market requirement

• Storage conditions: Store in a cool, dry place below 25°C, away from direct sunlight

• Packaging sizes: 10×10 tablets, bulk packs, or customized requirements

4. Export Certifications

Taj Pharma’s Lamotrigine Tablets 50mg manufacturer & supplier facilities in Vapi, Gujarat are WHO-GMP, EU-GMP, and ISO-certified. Taj Pharma also provides COPP, FSC, and DMF support to ensure smooth product approval across global markets.

5. Target Countries & Export Markets

Taj Pharma exports Lamotrigine Tablets 50mg to more than 40+ countries, including:

• Africa (Nigeria, Kenya, South Africa, Ghana)

• Latin America (Brazil, Peru, Colombia, Chile)

• Middle East (UAE, Saudi Arabia, Iraq, Oman)

• Asia (Vietnam, Myanmar, Philippines, Sri Lanka)

• CIS nations (Uzbekistan, Kazakhstan, Georgia)

• European markets (Ukraine, Romania, Poland)

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma stands out as the 1 Lamotrigine Tablets 50mg manufacturer in India due to its quality-first philosophy and global healthcare commitment.

1. State-of-the-art Manufacturing

• WHO-GMP and EU-GMP approved plants in Vapi, Gujarat

• Automated production lines ensuring consistency and purity

• Stringent in-house quality control at every stage

2. Affordable Pricing & Quality Assurance

• Competitive pricing to meet tender supply requirements

• WHO-prequalified raw materials

• Multi-step quality checks ensuring international compliance

3. Global Presence & Supply Chain Support

• Exporting to top 20 global markets

• Partnerships with government health ministries, NGOs, and private buyers

• Seamless supply chain management for timely delivery

4. Top 20 Countries Exporting Lamotrigine Tablets 50mg

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification 

Looking for a reliable Lamotrigine Tablets 50mg manufacturer & supplier in India?
Taj Pharma offers world-class quality, global regulatory support, and competitive pricing.

👉 Contact Taj Pharma today to explore bulk supply, export partnerships, or PCD Pharma Franchise opportunities.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

Top 20 FAQs  

1. What are Lamotrigine Tablets 50mg used for?
They are used to control seizures in epilepsy and to stabilize mood in bipolar disorder.

2. Is Taj Pharma a WHO-GMP certified manufacturer?
Yes, Taj Pharma’s Vapi facility is WHO-GMP, EU-GMP, and ISO-certified.

3. Can Lamotrigine cure epilepsy?
No, it cannot cure epilepsy but controls seizures as long as treatment continues.

4. How long does Lamotrigine take to work?
It usually takes 6 weeks to show full therapeutic effects.

5. What are the side effects?
Common side effects include dizziness, headache, tremors, blurred vision, nausea, and skin rash.

6. Is Lamotrigine safe during pregnancy?
Clinical studies suggest no increased risk of major birth defects, but always consult a doctor.

7. Can it be used in children?
Yes, under strict medical supervision, it is prescribed for children with epilepsy.

8. What is the shelf-life of Lamotrigine Tablets 50mg?
24–36 months depending on packaging and market.

9. Does Taj Pharma provide custom packaging?
Yes, with buyer-specific branding and multilingual labeling.

10. Where is Taj Pharma located?
Headquartered in Mumbai, with manufacturing facilities in Vapi, Gujarat.

11. Does Taj Pharma export globally?
Yes, to 40+ countries across Africa, Asia, Middle East, and Latin America.

12. What regulatory documents are provided?
WHO-GMP, COPP, FSC, CTD dossier, COA, MSDS, stability data.

13. Is Lamotrigine available for PCD Pharma Franchise?
Yes, Taj Pharma offers PCD franchise opportunities across India.

14. Can Lamotrigine interact with other drugs?
Yes, especially with anticonvulsants; doctors must monitor sodium levels.

15. How should Lamotrigine Tablets be stored?
In a cool, dry place below 25°C.

16. Does Taj Pharma supply bulk API also?
Yes, Lamotrigine API is available for formulation manufacturers.

17. Is the medicine cost-effective?
Yes, Taj Pharma ensures affordable pricing for both domestic and export markets.

18. How does Lamotrigine affect sleep?
It may cause drowsiness or insomnia initially but stabilizes over time.

19. What makes Taj Pharma different?
Global certifications, 100% regulatory compliance, and buyer-first policies.

20. How can buyers place orders?
By contacting Taj Pharma directly via email or website inquiry form.

Taj Pharma is the leading Lamotrigine Tablets 50mg manufacturer in India, providing WHO-GMP certified medicines, global regulatory support, and reliable exports. With a strong presence in 40+ countries, Taj Pharma has earned the trust of international healthcare buyers, importers, and distributors. If you’re looking for a trusted supplier for Lamotrigine Tablets 50mg export from India, Taj Pharma is your best partner for quality, affordability, and timely delivery.