IndiaMart
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Sodium Valproate is a widely prescribed antiepileptic drug (AED) that plays a central role in the treatment of seizure disorders and bipolar mood conditions. The gastro-resistant formulation of Sodium Valproate is specifically designed to minimize gastric irritation and enhance patient compliance. As global demand for high-quality neurological medications continues to grow, there is increasing need for GMP-compliant, stable, and effective sodium valproate formulations.
At BluepillExpress, we offer specialized third-party manufacturing for Gastro-Resistant Sodium Valproate, tailored to meet international pharmacopoeial standards (IP/BP/USP/EP). Backed by our WHO-GMP-certified facilities, strict quality control systems, and regulatory expertise, we help brands deliver value, trust, and therapeutic reliability to patients worldwide.
What is Gastro-Resistant Sodium Valproate?
Sodium Valproate is the sodium salt of valproic acid, an anticonvulsant and mood-stabilizing drug. The gastro-resistant form is designed to resist disintegration in the stomach and instead release its contents in the intestines, reducing gastrointestinal side effects like nausea and vomiting.
Therapeutic Class: Antiepileptic, Anticonvulsant, Mood Stabilizer
Mechanism of Action: Increases GABA levels in the brain; stabilizes neuronal firing; suppresses epileptic discharges
Route of Administration: Oral (Gastro-resistant Tablets)
Therapeutic Indications
Sodium Valproate is effective across a range of neurological and psychiatric disorders, especially when gastric tolerance and long-term therapy are required.
Primary Uses:
- Epilepsy (Generalized and Partial Seizures)
- Absence Seizures (Petit Mal)
- Mania in Bipolar Disorder
- Schizoaffective Disorder (off-label)
- Migraine Prophylaxis (off-label)
- Neuropathic Pain Management
- Aggression in Autism Spectrum Disorders (ASD)
Gastro-resistant tablets ensure controlled release, reduced gastric irritation, and improved compliance—particularly essential in pediatric, geriatric, and long-term patients.
Why Choose BluepillExpress for Sodium Valproate Manufacturing?
At BluepillExpress, we bring together pharmaceutical engineering excellence and regulatory know-how to deliver world-class third-party manufacturing solutions for sodium valproate and other central nervous system (CNS) drugs.
Key Benefits:
- WHO-GMP and ISO 9001:2015 certified units
- Specialized R&D for gastro-resistant and controlled-release formulations
- Advanced coating and enteric polymer technologies
- Regulatory compliance with IP, BP, USP, and EP standards
- Batch consistency, low impurity profiles, and high yield
- Full private labeling, regulatory documentation, and global shipping
- Custom packaging with serialization and QR codes (if required)
We serve clients across regulated, semi-regulated, and emerging markets with integrity and precision.
Dosage Forms and Strengths
We manufacture Gastro-Resistant Sodium Valproate tablets in multiple strengths and blister configurations.
Available Strengths:
- Sodium Valproate 200 mg Gastro-Resistant Tablets
- Sodium Valproate 300 mg Gastro-Resistant Tablets
- Sodium Valproate 500 mg Gastro-Resistant Tablets
We also offer combination formulations (e.g., Sodium Valproate + Valproic Acid) on request.
All formulations are engineered for optimum drug release in the intestine, maximizing bioavailability while minimizing gastrointestinal disturbances.
Product Composition
Each gastro-resistant tablet is manufactured using high-purity API, premium excipients, and specialized coating polymers that prevent early release in the stomach.
Example: Sodium Valproate 500 mg Gastro-Resistant Tablet
- Active Ingredient: Sodium Valproate IP/BP/USP 500 mg
- Excipients: Microcrystalline cellulose, maize starch, colloidal silicon dioxide, magnesium stearate, and enteric coating polymers (e.g., Eudragit L/S series)
Our formulations are free from artificial colorants and unnecessary fillers, ensuring safety and tolerability.
Manufacturing Process Overview
Our manufacturing facility is equipped with dedicated CNS production areas, including coating zones for gastro-resistant tablets.
Process Steps:
- API Verification: Raw materials are tested for identity, assay, and microbial safety
- Granulation & Blending: Wet or dry granulation depending on formula stability
- Tablet Compression: Controlled weight, hardness, and friability parameters
- Enteric Coating: Applied using fluid bed technology or pan coaters with Eudragit or similar polymers
- Drying & Curing: Ensures uniform enteric layer formation and resistance
- Packaging: In Alu-Alu or blister packs with protective inserts
- Quality Testing: In-process controls and final QC testing
Our teams ensure repeatable batch quality with data integrity and full documentation.
Quality Control and Compliance
Each batch of Gastro-Resistant Sodium Valproate undergoes comprehensive testing in accordance with global standards.
Testing Protocols:
- API Assay & Uniformity of Content
- Dissolution in Simulated Intestinal Fluid
- Enteric Coating Resistance in Simulated Gastric Fluid (SGF)
- Microbial Load Testing
- Related Substances and Impurity Profiling
- Stability Testing (Zone II, III, IVa/IVb)
We provide a Certificate of Analysis (COA) and retain samples for future quality audits.
Packaging and Customization
BluepillExpress offers full branding and packaging customization to align with your company’s image and regional market preferences.
Packaging Formats:
- Blister packs: 10×10, 10x1x10
- Alu-Alu strips for moisture and light protection
- HDPE bottles for bulk supply
- Laminated cartons with product inserts
- Multilingual labeling and serialization options
- Barcoding, QR coding, and track & trace support
We support private labeling, OEM contracts, and white label services.
Regulatory Support and Documentation
Our regulatory team prepares comprehensive documentation to ensure swift registration and global compliance.
Documentation Provided:
- WHO-GMP Certificate
- Certificate of Pharmaceutical Product (COPP)
- Product Dossier (CTD/ACTD formats)
- Certificate of Analysis (COA)
- Stability data (real-time and accelerated)
- Batch Manufacturing Record (BMR)
- Master Formula Record (MFR)
- Safety Data Sheet (SDS)
- Free Sale Certificate (FSC)
We support filings in Asia, Africa, Middle East, LATAM, CIS countries, and Pacific Islands.
Export and Logistics Services
BluepillExpress is a reliable global exporter of Sodium Valproate and other CNS drugs. We ensure efficient, safe, and compliant delivery.
Export Destinations:
- Africa: Kenya, Ghana, Ethiopia, Nigeria, Uganda
- Asia-Pacific: Vietnam, Bangladesh, Philippines, Nepal
- Middle East: UAE, Iraq, Jordan, Yemen
- CIS Nations: Uzbekistan, Kyrgyzstan, Georgia
- South America & Caribbean: Dominican Republic, Peru, Bolivia, Guyana
- Island Markets: Fiji, Papua New Guinea, Maldives
We handle full export documentation, including commercial invoice, packing list, airway bill, COA, and customs clearance.
Who Should Partner with BluepillExpress?
Our manufacturing services for Gastro-Resistant Sodium Valproate are ideal for:
- Generic pharmaceutical companies
- CNS and neurology-focused brands
- Private label medication marketers
- Distributors and hospital supply chains
- Government and institutional tenders
- Telehealth and mail-order pharmacies
- Mental health and migraine product lines
We enable small, mid-sized, and large-scale pharma businesses to grow globally with confidence.
Why BluepillExpress?
- GMP-Certified Manufacturing Facilities
- Specialized Formulation Expertise in CNS & Gastro-Resistant Tablets
- Regulatory & Documentation Support for 30+ Countries
- Flexible Production Volumes and Competitive Pricing
- Private Label, OEM, and White Label Services
- 100% Batch Traceability and Transparent Communication
- Dedicated Support from Production to Delivery
