Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg

Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Sodium Valproate & Valproic acid Controlled Release Tablets 135mg+58mg
B) Sodium Valproate & Valproic acid Controlled Release Tablets 200mg+87mg
C) Sodium Valproate & Valproic acid Controlled Release Tablets 333mg+145mg
D) Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Sodium Valproate & Valproic acid Controlled Release Tablets 135mg+58mg
Each film coated Controlled Release tablet contains:
Sodium Valproate IP……………………135mg
Valproic acid IP…………………………….58mg
(Both together corresponds to sodium valproate IP 150mg)
Excipients………………………………………q.s.
Colour: Erythrosine

B) Sodium Valproate & Valproic acid Controlled Release Tablets 200mg+87mg
Each film coated Controlled Release tablet contains:
Sodium Valproate IP…………………….200mg
Valproic acid IP……………………………….87mg
(Both together corresponds to sodium valproate IP 250mg)
Excipients……………………………………..q.s.
Colour: Ponceau 4 R

C) Sodium Valproate & Valproic acid Controlled Release Tablets 333mg+145mg
Each film coated Controlled Release tablet contains:
Sodium Valproate IP…………………333mg
Valproic acid IP…………………………145mg
(Both together corresponds to sodium valproate IP 500mg)
Excipients…………………………………..q.s.
Colour: Quinoline yellow SS

D) Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg
Each film coated Controlled Release tablet contains:
Sodium Valproate IP…………………..499mg
Valproic acid IP……………………………217mg
(Both together corresponds to sodium valproate IP 750mg)
Excipients………………………………………q.s.
Colour: Lake brilliant blue

THERAPEUTIC INDICATIONS:

Sodium Valproate + Valproic Acid is used in the treatment of epilepsy.

CAUTION &  WARNING:

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

 WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Physician.

Introduction to Sodium Valproate & Valproic Acid Controlled Release Tablets 499mg+217mg

Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg are a combination of antiepileptic medications widely used to manage epilepsy, bipolar disorder, and migraine prevention. These tablets work by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, a calming neurotransmitter, which helps stabilize neuronal activity.

Taj Pharma, a leading manufacturer, supplier, and exporter in India, produces these high-quality controlled-release tablets with stringent quality standards. Their extended-release formulation ensures consistent therapeutic levels over 24 hours, enhancing patient compliance and seizure control.

Global demand for Sodium Valproate & Valproic acid controlled-release formulations has surged due to increasing awareness of neurological disorders and mental health treatments, making these tablets a preferred choice for international distributors and healthcare providers.

2. In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures seamless global trade and regulatory compliance by providing:

• Certificate of Analysis (COA)

• WHO-GMP Certification

• EU-GMP compliance documentation

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD dossiers for registration in multiple countries

• Free Sale Certificate

• Stability data and batch records per ICH guidelines

These documents allow easy import and distribution across international markets.

Custom Packaging & Labeling

Taj Pharma offers flexible packaging and labeling options:

• Alu-Alu blister packs for controlled-release tablets

• HDPE bottles for bulk supply

• Private labeling with distributor branding

• Country-specific regulatory labeling

This ensures market-ready products that comply with local regulatory authorities.

Shelf-Life, Storage, and Dosage Form

• Dosage Form: Controlled-Release Tablet

• Strength: 499mg Sodium Valproate + 217mg Valproic Acid

• Shelf-life: 24–36 months

• Storage: Store below 25°C in a cool, dry place, away from sunlight

Export Certifications

Taj Pharma’s products are certified by:

• WHO-GMP

• EU-GMP for selected markets

• ISO 9001:2015

• COPP for multiple countries

• CTD/ACTD dossiers for registration abroad

These certifications ensure global regulatory compliance and high-quality manufacturing standards.

Target Countries & Export Markets

Taj Pharma exports Sodium Valproate & Valproic Acid Controlled Release Tablets to more than 50 countries, including:

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

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

• Middle East: UAE, Oman, Iraq, Yemen

• CIS Countries: Kazakhstan, Uzbekistan, Georgia, Ukraine

• Latin America: Peru, Ecuador, Bolivia

3. Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter

A. State-of-the-Art Manufacturing

Taj Pharma operates a modern manufacturing facility in Vapi, Gujarat, featuring:

• Advanced cleanrooms and controlled environments

• Automated production lines for tablets

• Sophisticated quality control laboratories

• Rigorous in-process and finished product testing

Each batch of Sodium Valproate & Valproic acid Controlled Release Tablets 499mg+217mg undergoes stringent checks for purity, potency, and consistency in compliance with WHO-GMP and PIC/S guidelines.

B. Affordable Pricing & Quality Assurance

Taj Pharma balances quality and affordability by:

• Sourcing APIs in-house

• Optimizing production efficiency

• Maintaining internationally recognized quality standards

This allows global buyers and distributors to access premium antiepileptic medications at competitive prices.

C. Global Presence & Supply Chain Support

Taj Pharma provides:

• Reliable door-to-port shipping

• Assistance with import registration and regulatory approvals

• Bulk supply for hospitals, distributors, and institutional tenders

• Real-time inventory and shipment tracking

This ensures timely delivery and uninterrupted supply to global partners.

D. Top 20 Countries Exporting

Taj Pharma exports these controlled-release tablets to:

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

4. Technical Product Specification Table

5. Call to Action  

If you are searching for a reliable WHO-GMP-certified manufacturer of Sodium Valproate & Valproic Acid Controlled Release Tablets 499mg+217mg in India, Taj Pharma is your ultimate partner.

Contact Taj Pharma for:

• Competitive pricing and bulk supply

• Private labeling and contract manufacturing

• Complete regulatory dossier support

• PCD Pharma Franchise opportunities

📞 Contact:
Taj Pharmaceuticals Ltd., Vapi, Gujarat, India
🌐 www.tajpharma.in
✉️ Email: info@tajpharma.com

6. Top 20 FAQs  

1. What is Sodium Valproate & Valproic Acid used for?
For epilepsy, bipolar disorder, and migraine prevention.

2. Who manufactures these tablets in India?
Taj Pharma is the leading manufacturer and exporter.

3. Are these tablets WHO-GMP certified?
Yes, the manufacturing facility is WHO-GMP and ISO certified.

4. Can buyers request private labeling?
Yes, private labeling and custom packaging are available.

5. What is the shelf life?
24–36 months under recommended storage conditions.

6. Are there side effects?
Common effects include weight gain, sleepiness, tremors, and dizziness.

7. How do these tablets work?
They increase GABA levels to stabilize brain activity.

8. Are they suitable for long-term use?
Yes, under medical supervision for chronic conditions.

9. Can they be used for migraine prevention?
Yes, these tablets help reduce migraine frequency and severity.

10. What are the packing options?
Alu-Alu blisters and HDPE bottles for bulk supply.

11. Are these tablets exported globally?
Yes, Taj Pharma exports to over 50 countries.

12. Are CTD dossiers available for registration abroad?
Yes, CTD / ACTD dossiers are available.

13. Do they require prescription?
Yes, they are prescription-only medications.

14. Can they cause liver injury?
Yes, rare cases of hepatotoxicity can occur; monitoring is required.

15. How should they be stored?
Store below 25°C in a dry place, away from sunlight.

16. Can distributors order in bulk?
Yes, Taj Pharma provides low MOQ and bulk supply options.

17. Are they safe during pregnancy?
Use only under strict medical supervision due to potential fetal risks.

18. Do these tablets interact with other medications?
Yes, consult a doctor or pharmacist for potential drug interactions.

19. Does Taj Pharma provide supply chain support?
Yes, including real-time tracking and import assistance.

20. How to contact Taj Pharma for orders?
Visit www.tajpharma.in or email info@tajpharma.com.