In the global pharmaceutical market, the most recognized brand name for Sodium Valproate 500 mg (often in controlled-release form) is Epilim (Sanofi). In India, the market is led by brands such as Valparin Chrono (Abbott) and Epilex Chrono (Abbott/Torrent).
As a pharmacist and manufacturer, I view Sodium Valproate as a broad-spectrum anticonvulsant and mood stabilizer that is technically unique because it targets multiple pathways in the brain simultaneously.
At your WHO-GMP facility in Mumbai, this is a high-precision SKU, typically manufactured as “Chrono” or “Controlled Release” (CR) tablets to ensure stable plasma levels over 24 hours.
Primary Clinical Indications
-
Epilepsy: Management of generalized, partial, and absence seizures.
-
Bipolar Disorder: Treatment and prevention of manic episodes.
-
Migraine Prophylaxis: Prevention of chronic migraine headaches (not for acute attacks).
Mechanism: Triple-Action Neuromodulation
Sodium Valproate works by stabilizing hyper-excitable neurons through three distinct mechanisms.
GABA Enhancement: It inhibits the enzymes that break down GABA (the brain’s primary inhibitory neurotransmitter) and stimulates its synthesis, effectively “calming” the brain.
Sodium Channel Blockade: It blocks voltage-gated Sodium ($Na^+$) channels, preventing the rapid-fire electrical discharges that cause seizures.
Calcium Channel Modulation: It also limits T-type Calcium ($Ca^{2+}$) channels, which is why it is effective for absence seizures.
The Pharmacist’s “Technical Warning”
-
The “Teratogenicity” Alert: This is the most critical warning. Sodium Valproate causes severe birth defects (Neural Tube Defects). It is strictly contraindicated in women of childbearing age unless a “Pregnancy Prevention Program” is in place.
-
Hepatotoxicity & Pancreatitis: Rare but life-threatening liver failure or inflammation of the pancreas can occur. Regular Liver Function Tests (LFTs) are mandatory.
-
Therapeutic Drug Monitoring (TDM): Valproate has a narrow window. Serum levels should be monitored (typically 50–100 mg/L) to ensure efficacy and avoid toxicity.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
-
The “Chrono” Technology: On your marketplace, highlight if your 500 mg tablets use Controlled Release (CR) technology. This reduces “peak-and-trough” side effects and allows for once-daily dosing, a major selling point for international B2B buyers.
-
Stability for Export: Sodium Valproate is extremely hygroscopic (absorbs moisture from the air). Utilizing Alu-Alu blister packaging is non-negotiable for maintaining a 36-month shelf life in Zone IVb tropical regions.
-
Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international neurology tenders.