Sodium Valproate API Manufacturer & Supplier in India

Sodium Valproate is a broad-spectrum antiepileptic and mood-stabilizing active pharmaceutical ingredient. Mediocon Inc supplies high-purity Sodium Valproate conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sodium Valproate enhances GABA activity and modulates sodium and calcium channels to prevent seizure activity. It is indicated for epilepsy (generalized and partial), bipolar disorder, and migraine prophylaxis.

Key Features

• High-purity pharmaceutical grade API
• IP / BP / EP / USP / INH / FCC / NF compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• Epilepsy — generalized and focal seizures
• Bipolar disorder and mania
• Migraine prophylaxis
• Absence seizure treatment

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Sodium Valproate (CAS 1069-66-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sodium Valproate is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries