Description
Sodium Valproate Tablets (Valproic Acid)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a premier manufacturer of Sodium Valproate Tablets (the salt form of Valproic Acid) in India. This broad-spectrum anticonvulsant is essential for treating epilepsy and bipolar disorder. We produce high-quality Enteric Coated (EC) and Controlled Release (CR) tablets. Our facility adheres to strict WHO-GMP standards. Therefore, we guarantee stability and patient compliance. Healthy Inc manages our global exports and bulk tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Sodium Valproate Tablets | | Active Ingredient | Sodium Valproate IP / BP / USP (Valproic Acid) | | Strength | 200mg / 300mg / 500mg | | Dosage Form | Enteric Coated / Controlled Release Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Anticonvulsant / Mood Stabilizer | | Shelf Life | 36 Months | | Packaging | 10×10 Alu-Alu Blister / Bulk Jar |
3. Manufacturing Sodium Valproate 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. Sodium Valproate is highly hygroscopic (absorbs moisture from air). Therefore, we manufacture in low-humidity zones (<40% RH). Furthermore, Valproic Acid severely irritates the stomach. To solve this, we use advanced Enteric Coating technology. This ensures the tablet bypasses the stomach and dissolves in the intestine, preventing nausea.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Sodium Valproate Tablets. We use Alu-Alu packaging to provide the highest barrier against moisture. We serve markets in LATAM, Africa, and Southeast Asia. We ensure timely shipment for chronic disease programs.
4. Quality Assurance We test every batch rigorously.
Assay Verification: We use HPLC testing. This confirms the exact drug content.
Dissolution (Stage 1 & 2): We test the enteric coating. The tablet must not dissolve in acid (stomach simulation) but must dissolve rapidly in buffer (intestine simulation).
Moisture Content: We strictly check water content. Excess moisture degrades the tablet quickly.
5. Why Use Sodium Valproate Tablets? This drug is a first-line treatment for multiple seizure types.
Mechanism: It increases the levels of GABA (a calming neurotransmitter) in the brain.
Effect: It stabilizes electrical activity in the brain, preventing seizures and mood swings.
Key Indications:
Treatment of Epilepsy (Generalised and Partial Seizures).
Management of Bipolar Disorder (Manic Episodes).
Prophylaxis of Migraine Headaches.
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 Sodium Valproate Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this the same as Valproic Acid? A: Yes, Sodium Valproate converts to Valproic Acid in the body. It is the stable solid form used for tablets.
Q: Are these tablets Enteric Coated? A: Yes, we manufacture Enteric Coated tablets to prevent vomiting and stomach pain.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: Dosage is highly individualized. It typically starts at 600mg/day and is increased based on body weight and response.
Administration: Swallow the tablet whole. Do not crush or chew, as this damages the enteric coating and causes irritation.
Timing: Take with meals to further reduce stomach upset.
9. Side Effects and Precautions
Common Side Effects: Nausea, tremor, weight gain, or hair loss may occur.
Liver Warning: Valproic Acid can cause liver toxicity (Hepatotoxicity). Liver function tests are required regularly.
Pregnancy Warning: This drug is Teratogenic (can cause birth defects). It should not be used during pregnancy unless absolutely necessary.
10. Storage Instructions
Store below 25°C in a dry place.
Critical: Keep tightly closed or in original blister. Extremely sensitive to moisture.
Keep out of reach of children.
