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Valproic Acid Tablets (Sodium Valproate Equivalent)

Enteric-coated tablets containing sodium valproate equivalent to valproic acid BP 500 mg, for specialist-directed treatment of selected neurological and psychiatric conditions.

Product Overview

Composition per enteric-coated tablet: Sodium Valproate equivalent to Valproic Acid BP 500 mg; excipients q.s. Exact sodium-valproate salt mass must be confirmed from the approved formulation.

Dosage form: Enteric-coated tablet (not assumed to be controlled-release).

Therapeutic class: Anticonvulsant / Mood stabilizer; not an antihypertensive or cardiac medicine.

Manufacturer named in brief: Healthy Life Pharma Pvt. Ltd. Exporter named: Healthy Inc. Certifications require documentary verification.

B2B enquiries: +91 7710003340

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Product Information

Valproic Acid Tablets (Sodium Valproate Equivalent) is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

1. Product Introduction

Valproate is a broad-spectrum antiseizure medicine also used in certain jurisdictions for the management of acute manic episodes in bipolar disorder. The supplied product label specifies an enteric-coated tablet containing sodium valproate equivalent to valproic acid BP 500 mg. This is a prescription-only medicine requiring careful patient selection and monitoring.

Healthy Life Pharma Pvt. Ltd. and Healthy Inc are identified in the supplied commercial brief as manufacturer and exporter. Facility and product certifications must be verified before publishing as established claims.

Critical safety notice: Valproate can cause severe fetal harm, major congenital malformations and neurodevelopmental disorders. Pregnancy-prevention and prescribing restrictions differ by jurisdiction and must be followed rigorously.

2. Product Specifications

ProductValproic Acid Tablets 500 mg (Sodium Valproate equivalent)
Label compositionEach enteric-coated tablet contains sodium valproate equivalent to valproic acid BP 500 mg; excipients q.s.
Strength500 mg valproic-acid equivalent (confirmed in supplied text)
Dosage formEnteric-coated tablet / delayed-release presentation
StandardBP for valproic-acid equivalent as stated on supplied label; final finished-product specification must be verified
Therapeutic classAnticonvulsant / Mood stabilizer
Other strengths200 mg and 300 mg mentioned in general brief, not confirmed by supplied product label
Packaging / shelf lifeSubject to approved registration and stability evidence

3. Manufacturing Technology

Valproate formulations require control of API identity and potency, moisture exposure, blend uniformity, compression and coating integrity. Enteric coating is designed to resist gastric conditions and release medicine at higher intestinal pH. The product must not be described as controlled-release without separate release-profile evidence.

Specific humidity limits, coating chemistry, equipment, manufacturing site and packaging configurations are subject to verified batch records and approved dossiers.

4. Quality Assurance

  • Identity, assay, related substances and dosage-unit uniformity against the applicable approved specification.
  • Enteric-coating integrity and two-stage dissolution or other pharmacopoeial release testing appropriate to the product.
  • Moisture, physical tablet attributes and packaging performance where required.
  • Stability studies to justify labeled storage conditions and shelf life.

Do not publish fixed assay ranges or dissolution criteria unless confirmed for this exact registered product.

5. Why Use Valproate?

Valproate affects multiple neuronal pathways, including enhancing inhibitory GABA signaling and modulation of voltage-gated ion channels. It can reduce seizure activity and has mood-stabilizing effects.

  • Epilepsy: May be indicated for selected seizure types, depending on national labeling and patient-specific risk assessment.
  • Bipolar disorder: Certain valproate formulations are approved for acute manic episodes in some countries; indications for this exact enteric-coated product must be checked locally.
  • Migraine prevention: Some valproate products have approved preventive indications, but use is highly restricted in people who may become pregnant; not a treatment for an acute migraine attack.

Valproate is not a treatment for hypertension or cardiac disease.

6. Export and Regulatory Support

Potential B2B documentation includes approved product specifications, certificates of analysis and country-specific CTD/ACTD registration dossiers, where available. Supply requires compliance with the destination country's marketing authorization and valproate risk-minimization requirements.

WHO-GMP, COPP, Free Sale Certificate, Star Export House status, approved markets and packaging claims must be confirmed with current documentary evidence.

7. Frequently Asked Questions

Q: Is sodium valproate identical to valproic acid by weight?
A: No. Sodium valproate is a salt form; the label specifies the amount equivalent to valproic acid. Do not substitute milligram-for-milligram without checking the formulation and approved labeling.

Q: Is an enteric-coated tablet the same as controlled-release?
A: No. Enteric coating delays release until after the stomach; controlled-release products have a distinct prolonged-release profile.

Q: Can it be used in pregnancy?
A: Valproate carries a high risk of birth defects and neurodevelopmental harm. Strict national restrictions apply, and specialist advice is essential. Never stop seizure medication abruptly without urgent medical advice.

Q: Which strength is supported by the supplied label?
A: 500 mg valproic-acid equivalent per enteric-coated tablet.

8. Dosage and Administration

Dosage must be individualized by a qualified prescriber based on indication, age, body weight, other medicines, laboratory results and the specific formulation. Enteric-coated and extended-release products are not automatically interchangeable. Swallow enteric-coated tablets whole unless the approved label explicitly permits otherwise; do not crush or chew.

Do not stop valproate abruptly without specialist guidance because seizures or other symptoms may worsen. Patients should follow the approved medication guide and any mandatory pregnancy-prevention program.

9. Side Effects and Precautions

  • Common: Nausea, tremor, drowsiness, weight changes, hair thinning and gastrointestinal symptoms.
  • Serious: Potentially fatal liver injury, pancreatitis, hyperammonemic encephalopathy, thrombocytopenia/bleeding, severe skin reactions and suicidal thoughts or behavior.
  • Pregnancy and reproductive risk: Major fetal malformations and neurodevelopmental harm; strict prescribing restrictions, contraception counseling and specialist review are essential. Some jurisdictions also restrict initiation in males because of potential reproductive risks.
  • Contraindications/precautions: Significant hepatic disease, known urea-cycle disorders, certain mitochondrial disorders (including POLG-related disease), and relevant drug interactions.
  • Monitoring: Liver tests, blood counts and clinical status as advised; serum valproate levels may be indicated in selected situations.

Urgent assessment is needed for severe abdominal pain, persistent vomiting, jaundice, unusual bruising, marked lethargy or confusion.

10. Storage Instructions

Store in the original protective packaging under the temperature and humidity conditions stated on the approved product label. Protect from excessive moisture. A universal below-25°C requirement and 36-month shelf life cannot be confirmed from the supplied label. Keep out of reach of children.

For healthcare professional and B2B reference. Product availability, approvals, certifications, manufacturing processes, packaging and prescribing details must be verified for the relevant market.