Description
Carbamazepine Tablets (100mg / 200mg / 400mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Carbamazepine Tablets in India. This potent anticonvulsant and mood stabilizer is a first-line treatment for Epilepsy and the drug of choice for Trigeminal Neuralgia. We produce both Immediate Release and Controlled Release (CR/SR) formulations to ensure stable plasma levels and reduce side effects. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and neurology tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Carbamazepine Tablets | | Generic Name | Carbamazepine USP / BP / IP | | Strength | 100mg / 200mg / 400mg | | Dosage Form | Uncoated Tablet / Controlled Release (CR) Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Anticonvulsant / Analgesic (Neurotropic) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister (Alu-PVC/PVDC) / 1000s Bulk Jar |
3. Manufacturing Carbamazepine Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Carbamazepine is chemically prone to Polymorphic Changes (changing crystal structure) and forming hydrates if exposed to moisture, which causes the tablets to harden and fail dissolution tests. To prevent this, we use rigorous Polymorph Screening during raw material selection and manufacture in low-humidity suites. Our Controlled Release (CR) tablets use a specialized hydrophilic matrix that ensures the drug is released steadily over 12 hours, preventing peak-dose dizziness.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Carbamazepine Tablets. We supply mental health institutions and epilepsy clinics globally. We ensure the packaging provides a robust moisture barrier to maintain the drug’s bioavailability even in tropical export markets.
4. Quality Assurance We test every batch rigorously.
Dissolution: We strictly monitor the release rate. For CR tablets, we verify the release profile at 1, 4, 8, and 12 hours to guarantee 24-hour seizure coverage with twice-daily dosing.
Polymorph Stability: We ensure the active ingredient remains in the therapeutically active crystal form.
Assay: We confirm the potency to ensure effective seizure control.
5. Why Use Carbamazepine Tablets? This drug stabilizes hyper-excited nerve membranes.
Mechanism: It inhibits sustained repetitive firing of neurons by blocking voltage-dependent Sodium Channels.
Effect: It prevents the spread of seizure discharge in the brain and dampens the shooting pain transmission in the trigeminal nerve.
Key Indications:
Epilepsy: Treatment of partial seizures with complex symptomatology and generalized tonic-clonic seizures.
Trigeminal Neuralgia: First-line treatment for this severe facial pain condition.
Bipolar Disorder: Management of acute mania and maintenance treatment (mood stabilization).
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Carbamazepine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Do you offer the CR (Controlled Release) version? A: Yes, the 200mg CR and 400mg CR are our most popular exports as they improve patient compliance and reduce side effects.
Q: Is this effective for nerve pain? A: Yes, it is the specific drug of choice for Trigeminal Neuralgia (facial nerve pain).
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Epilepsy: Usually started at 100-200mg once or twice daily, increased gradually to 800-1200mg daily.
Trigeminal Neuralgia: 100mg twice daily initially, increasing until pain relief is obtained (usually 200-800mg daily).
Administration: Take with food to increase absorption and reduce stomach upset.
9. Side Effects and Precautions
Skin Reactions (SJS/TEN): Rare but severe skin reactions can occur. Patients of Han Chinese or Thai origin should be screened for the HLA-B*1502 allele before starting treatment.
Bone Marrow Depression: Can cause low white blood cells (Leukopenia). Regular blood counts are recommended.
Dizziness/Drowsiness: Common at the start of therapy; usually subsides with time.
10. Storage Instructions
Store below 25°C in a dry place.
Moisture Sensitive: Keep strictly in the blister pack. Do not store in bathrooms.
Keep out of reach of children.
