Lamotrigine Tablets 200mg

Lamotrigine Tablets  200mg Technical Specification:

Product Name:	Lamotrigine Tablets USP
Brand Name:	Generics
Strength:	25mg, 50mg, 100mg, 150mg, 200mg
Dosage Form:	Tablets (Un-coated)
Route of Administration:	Via oral Route
Packing:	30s, 90s, 100s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:	COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:	Anti-Epileptic, Anticonvulsant
Indication:	Lamotrigine tablet use to treat epilepsy and bipolar disorder – NHS.
Storage:	Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

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 200mg

Lamotrigine Tablets 200mg is a widely prescribed antiepileptic medication used to prevent and control seizures in individuals with epilepsy. Beyond epilepsy, it also plays a crucial role in the treatment of bipolar disorder, especially in preventing mood episodes. The medicine works by calming overactive nerve signals in the brain and restoring stability to neural activity.

The rising global prevalence of neurological disorders has sharply increased the demand for Lamotrigine Tablets 200mg manufacturers in India, particularly because India is recognized as one of the largest exporters of affordable, high-quality generic medicines.

Taj Pharma, based in Vapi, Gujarat, is a leading WHO-GMP-certified manufacturer, supplier, and exporter of Lamotrigine Tablets 200mg. Known for quality, regulatory compliance, and cost competitiveness, Taj Pharma has established itself as a trusted partner for global buyers.

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Why Lamotrigine Tablets 200mg is in High Demand Globally

• Epilepsy impact: Around 50 million people worldwide suffer from epilepsy (WHO data), making it one of the most common neurological disorders.

• Bipolar disorder treatment: Lamotrigine is highly effective in preventing depressive episodes, a condition affecting over 40 million people worldwide.

• Safer alternative: Compared to older antiepileptic drugs, Lamotrigine has fewer sedative effects and better tolerability.

• Steady global growth: The global antiepileptic drug market is projected to surpass USD 25 billion by 2030, and Lamotrigine is a key contributor.

This makes India’s Lamotrigine Tablets 200mg manufacturers crucial players in supplying safe, effective, and affordable medicines to international markets.

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In-Depth Information for Importers, Exporters & Buyers

When sourcing pharmaceuticals internationally, buyers prioritize regulatory compliance, product stability, and affordability. Taj Pharma provides unmatched advantages to importers and distributors worldwide.

1. Regulatory Documentation Provided

• WHO-GMP / EU-GMP Certifications

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Certificate of Analysis (CoA) for every batch

• CTD/ACTD Dossier Support for product registrations

• Stability data available upon request

2. Packaging & Labeling Solutions

• Blister packs, strip packs, and bulk packs available

• Customized export-ready multilingual packaging

• Durable materials to protect tablets during transit

• Options for private labeling and branding for distributors

3. Shelf-life, Storage & Dosage Form

• Shelf life: 24–36 months

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

• Dosage form: Oral tablets, film-coated

• Strengths available: 25mg, 50mg, 100mg, and 200mg tablets

4. Export Certifications & Compliance

• WHO-GMP certified facilities

• EU-GMP for selected product lines

• ISO 9001:2015 certified

• Stringent compliance with US FDA and EMA guidelines

5. Target Export Markets

Taj Pharma supplies Lamotrigine Tablets 200mg across major international markets:

• Africa: Nigeria, Kenya, Ghana, South Africa, Tanzania

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

• Asia: Vietnam, Philippines, Myanmar, Nepal, Sri Lanka

• CIS Countries: Kazakhstan, Uzbekistan, Belarus, Ukraine

• Latin America: Peru, Ecuador, Chile, Bolivia

• Europe: UK, Romania, Germany (through partner companies)

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Why is the Most Trusted Manufacturer & Exporter

When global buyers search for a Lamotrigine Tablets 200mg manufacturer in India, Taj Pharma consistently emerges as the partner of choice.

1. State-of-the-Art Manufacturing

• US FDA & WHO-GMP approved plants in Vapi, Gujarat

• Strict adherence to ICH Q7 & cGMP guidelines

• Fully automated production & stringent quality control

2. Affordable Pricing & Quality Assurance

• Competitive bulk export pricing

• Zero tolerance for substandard batches

• In-house analytical and microbiological testing labs

3. Global Presence & Supply Chain Support

• Exporting to 40+ countries worldwide

• Experienced logistics & regulatory teams

• End-to-end custom clearance support for importers

4. Top 20 Export Countries

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 Specifications

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Call to Action

Looking for a reliable Lamotrigine Tablets 200mg manufacturer in India?

👉 Partner with Taj Pharma, India’s most trusted exporter of high-quality pharmaceutical formulations.

• 🌍 WHO-GMP/EU-GMP certified facilities

• 💊 Affordable bulk pricing

• 📦 Custom packaging & private labeling options

• 📜 Full regulatory and dossier support

📩 Contact us today at www.tajpharma.com to request samples, product quotations, or explore PCD Pharma Franchise opportunities.

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Top 20 FAQs

1. What are Lamotrigine Tablets 200mg used for?
They are prescribed for epilepsy (to control seizures) and bipolar disorder (to prevent mood episodes).

2. Who manufactures Lamotrigine Tablets 200mg in India?
Taj Pharma is a leading WHO-GMP-certified manufacturer and exporter from Vapi, Gujarat.

3. How long does Lamotrigine take to work?
It usually takes 6 weeks for the medicine to show full benefits, as doses must be increased gradually.

4. What are the common side effects?
Headache, dizziness, sleepiness, nausea, tremors, irritability, and mild skin rash.

5. Can Lamotrigine cause drowsiness?
Yes, some patients may feel sleepy or dizzy. Avoid driving or operating machinery until you know its effect.

6. Is Lamotrigine safe for long-term use?
Yes, under medical supervision, Lamotrigine is considered safe for long-term management.

7. What packaging options does Taj Pharma offer?
Blister packs, strip packs, bulk export packs, and custom private-label packaging.

8. What regulatory support does Taj Pharma provide?
Full COPP, FSC, CoA, CTD/ACTD dossier, stability studies are available for registrations.

9. What is the shelf-life of Lamotrigine Tablets 200mg?
Typically 24–36 months under proper storage conditions.

10. Does Taj Pharma offer PCD Pharma Franchise?
Yes, Taj Pharma provides PCD Pharma Franchise opportunities PAN India.

11. What is the storage condition?
Store below 25°C, away from light and moisture.

12. Can Lamotrigine be exported to Africa and CIS countries?
Yes, Taj Pharma actively exports to Africa, CIS, Middle East, and Latin America.

13. Is WHO-GMP certification available?
Yes, Taj Pharma’s facility is WHO-GMP & EU-GMP certified.

14. Can Lamotrigine Tablets 200mg be shipped in bulk?
Yes, bulk orders are supplied with customized export packaging.

15. What is the minimum order quantity (MOQ)?
Varies by country; typically 10,000 tablets for export orders.

16. Does Taj Pharma offer third-party manufacturing?
Yes, Taj Pharma is open to contract and third-party manufacturing.

17. How is Lamotrigine different from other antiepileptics?
It causes less sedation and is effective in mood stabilization compared to older drugs.

18. What are the strengths available?
25mg, 50mg, 100mg, and 200mg.

19. Can distributors request branded packs?
Yes, Taj Pharma offers private labeling for international buyers.

20. How can I import Lamotrigine Tablets 200mg from India?
Simply contact Taj Pharma with your requirements, and the export team handles documentation, logistics, and regulatory compliance.