Lamotrigine Dispersible Tablets 50mg

Lamotrigine Dispersible Tablets 50mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Lamotrigine Dispersible Tablets IP 25mg
B) Lamotrigine Dispersible Tablets IP 50mg
C) Lamotrigine Dispersible Tablets IP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Lamotrigine Dispersible Tablets IP 25mg
Each uncoated dispersible tablet contains:
Lamotrigine IP…………………25mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake tartrazine

B) Lamotrigine Dispersible Tablets IP 50mg
Each uncoated dispersible tablet contains:
Lamotrigine IP…………………50mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Ponceau 4 R

C) Lamotrigine Dispersible Tablets IP 100mg
Each uncoated dispersible tablet contains:
Lamotrigine IP…………………100mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake Ponceau 4 R

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 & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE: SCHEDULE H:TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.
Direction of use: Disperse the tablet in 10 ml of boiled and cooled water before administration.

Introduction to Lamotrigine Dispersible Tablets 50mg

Lamotrigine Dispersible Tablets 50mg are an advanced formulation of the anticonvulsant drug Lamotrigine, designed for ease of administration and enhanced patient compliance. These tablets can be swallowed whole, chewed, or dispersed in water or fruit juice—making them particularly suitable for pediatric and geriatric patients.

Lamotrigine is widely prescribed for the treatment of epilepsy and bipolar disorder, functioning by stabilizing electrical activity in the brain and controlling mood fluctuations. The global demand for Lamotrigine Dispersible Tablets 50mg has surged due to increasing cases of epilepsy and mood disorders across developing and developed nations.

Taj Pharma, a leading Lamotrigine Dispersible Tablets 50mg Manufacturer in India, guarantees consistent potency, purity, and global compliance across all production batches.

Therapeutic Uses of Lamotrigine Dispersible Tablets 50mg

• Epilepsy: Prevents and controls seizures by reducing abnormal brain activity.

• Bipolar Disorder: Prevents extreme mood swings, especially depressive episodes.

• Adjunct Therapy: Used alongside other anticonvulsants to enhance seizure control.

Lamotrigine carries an FDA warning due to the potential for severe skin reactions such as Stevens-Johnson Syndrome (SJS), especially in children or patients using high starting doses. Taj Pharma follows stringent pharmacovigilance and quality protocols to minimize such risks, ensuring every batch is clinically safe and WHO-GMP compliant.

Key Features and Benefits of Lamotrigine Dispersible Tablets 50mg by Taj Pharma

• High purity and bioavailability

• Easy dispersible formulation for flexible use

• Backed by WHO-GMP and ISO certifications

• Stringent quality assurance (QA/QC) under cGMP guidelines

• Affordable pricing for global markets

• Customizable packaging and labeling for private branding and tenders

  Dosage and Administration

Lamotrigine Dispersible Tablets 50mg can be taken with or without food, ideally at the same time each day to maintain consistent drug levels.

• For epilepsy, the dose is individualized based on patient response.

• For bipolar disorder, gradual titration minimizes side effects.

Caution: Avoid abrupt discontinuation as it may worsen seizures or mood symptoms. Always consult a healthcare professional before adjusting the dose.

Possible Side Effects

Most side effects are mild and transient, often resolving as the body adapts to treatment:

• Headache

• Dizziness or drowsiness

• Blurred or double vision

• Nausea or vomiting

• Back or abdominal pain

• Skin rash (monitor closely)

If serious allergic reactions or rash occur, discontinue use and seek medical attention immediately.

Regulatory and Export Information for Importers & Buyers

1. Documentation Provided by Taj Pharma

Taj Pharma supports international buyers and government tenders with comprehensive regulatory documentation, including:

• WHO-GMP Certificate

• COA (Certificate of Analysis)

• COPP (Certificate of Pharmaceutical Product)

• CTD / ACTD Dossiers

• Free Sale Certificate

• Stability Data

• Batch Manufacturing Records

• Regulatory Files for Registration Support

2. Custom Packaging & Labeling

Taj Pharma offers customized packaging solutions to align with import regulations and brand requirements. Packaging options include:

• Blister Packs / Alu-Alu Packs

• Bottle or Strip Packaging

• Private Label Printing & Branding

• Multilingual Labels and Inserts

3. Shelf-Life & Storage

• Shelf-life: 24–36 months (depending on storage conditions)

• Storage: Store below 30°C, away from direct sunlight and moisture.

4. Export Certifications

Taj Pharma holds multiple global certifications and approvals:

• WHO-GMP (World Health Organization – Good Manufacturing Practice)

• ISO 9001:2015 & ISO 14001:2015

• EU-GMP Equivalent Compliance

• COPP (for multiple countries)

• Comprehensive CTD dossiers for product registration

5. Target Export Markets

Taj Pharma exports Lamotrigine Dispersible Tablets 50mg to over 80 countries, with regulatory approvals and registrations in:

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

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

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

• CIS (Uzbekistan, Kazakhstan, Ukraine, Armenia)

• Middle East (UAE, Iraq, Jordan, Yemen, Saudi Arabia)

Why Taj Pharma is the Most Trusted Lamotrigine Dispersible Tablets 50mg Manufacturer in India

1. WHO-GMP Certified Facilities

Taj Pharma’s state-of-the-art facility in Vapi, Gujarat is WHO-GMP, ISO, and GLP certified, ensuring every product meets global pharmaceutical standards.

2. Quality Assurance & Global Compliance

From sourcing of APIs to final packaging, each step undergoes rigorous QA/QC monitoring, validated by in-house and third-party analytical labs.

3. Affordable Global Pricing

Taj Pharma combines cost-effective manufacturing with premium quality, making it the preferred partner for pharma tenders, hospital supply chains, and generic distributors worldwide.

4. Regulatory Expertise

Taj Pharma’s experienced regulatory team provides end-to-end dossier support, assisting importers and partners with rapid product registration and market authorization.

5. PCD Pharma Franchise & Third-Party Manufacturing

Taj Pharma offers PCD franchise opportunities across India and contract manufacturing services for brands looking to expand into the neuropsychiatry and CNS therapeutic segments.

Top 20 Countries Where Taj Pharma Exports Lamotrigine Dispersible Tablets 50mg

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Technical Product Specification 

 PAN India Manufacturer & Exporter

• Lamotrigine Dispersible Tablets 50mg Manufacturer & Supplier in India

• Lamotrigine Dispersible Tablets 50mg Exporter from Mumbai, Maharashtra

• Lamotrigine Dispersible Tablets 50mg PCD Pharma Franchise Available

• Lamotrigine Dispersible Tablets 50mg Best Price in India – Taj Pharma

• WHO-GMP Certified Manufacturer in Vapi, Gujarat

Partner with Taj Pharma Today

If you are an importer, distributor, or hospital buyer seeking a reliable WHO-GMP-certified Lamotrigine Dispersible Tablets 50mg manufacturer, Taj Pharma is your trusted partner.

📞 Contact Us:
Taj Pharma India Ltd.
Plot No. 5133, GIDC Industrial Estate,
Vapi, Gujarat, India – 396195
🌐 Website: www.tajpharma.in
📧 Email: info@tajpharma.com

Top 20 FAQs on Lamotrigine Dispersible Tablets 50mg

1. What is Lamotrigine Dispersible Tablets 50mg used for?
It is used to treat epilepsy and bipolar disorder by stabilizing brain activity.

2. Can these tablets be chewed or dissolved?
Yes, they can be swallowed, chewed, or dispersed in water/juice.

3. Who manufactures Lamotrigine Dispersible Tablets 50mg in India?
Taj Pharma Ltd., a WHO-GMP certified company based in Vapi, Gujarat.

4. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, and EU-GMP equivalent standards.

5. What is the shelf life of Lamotrigine Tablets?
Typically 24–36 months.

6. Does Taj Pharma offer private labeling?
Yes, private branding and custom packaging are available.

7. What are the common side effects?
Headache, nausea, dizziness, blurred vision, or mild rash.

8. Is this medicine safe for children?
Yes, under pediatric supervision with proper dosage adjustment.

9. Can Lamotrigine be stopped suddenly?
No, abrupt withdrawal may worsen seizures or mood swings.

10. Which countries does Taj Pharma export to?
Over 80 countries across Asia, Africa, LATAM, and the Middle East.

11. What is the recommended storage condition?
Store below 30°C, in a dry, dark place.

12. Is WHO-GMP certification mandatory for export?
Yes, and Taj Pharma complies fully.

13. Does Taj Pharma provide dossiers for registration?
Yes, full CTD/ACTD dossiers are available.

14. What dosage forms are available?
Dispersible tablets, regular tablets, and extended-release forms.

15. Can importers request custom packaging?
Yes, packaging can be customized as per regulatory or brand needs.

16. Does Taj Pharma support hospital and government tenders?
Yes, with competitive pricing and required documentation.

17. Is Lamotrigine safe with other anticonvulsants?
Yes, though dosage adjustment may be required.

18. Does Taj Pharma offer third-party manufacturing?
Yes, for global and domestic brands.

19. How to contact Taj Pharma for bulk orders?
Email: info@tajpharma.com or visit www.tajpharma.in

20. Why choose Taj Pharma for Lamotrigine Tablets?
Because of WHO-GMP quality, competitive pricing, and global reliability.