Neurological & CNS

Fosphenytoin SodiumThird Party Manufacturing in India

Looking to get Fosphenytoin Sodium manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
92134-98-0
Drug Class
Hydantoin anticonvulsant
Molecular Formula
C₁₆H₁₃N₂Na₂O₆P
Molecular Weight
406.24 g/mol
Grade Standards
IP, BP, USP
Therapeutic Category
Neurological & CNS
MOQ
Contact us for MOQ — varies by strength and dosage form
Dosage Forms
Injection

Mechanism of Action

Fosphenytoin Sodium works by acting as a highly water-soluble prodrug that rapidly converts into phenytoin once it enters the body. Within the bloodstream and liver, enzyme activity splits the phosphate group from fosphenytoin, releasing active phenytoin to target the central nervous system.

It binds preferentially to the inactive state of voltage-gated sodium channels on brain cell membranes. This action blocks the rapid influx of sodium ions into neurons, preventing the cells from firing the high-frequency, sustained electrical signals that initiate and spread epileptic seizures. By stabilizing these overactive neural pathways, the drug restores normal electrical activity in the brain.

Unlike traditional intravenous phenytoin, Fosphenytoin Sodium is highly compatible with standard intravenous solutions and carries a significantly lower risk of severe injection site reactions, such as purple glove syndrome. It is highly effective and well-tolerated for adult and pediatric patients requiring rapid seizure control in emergency settings.

Therapeutic Uses & Indications

Therapeutic Uses

Fosphenytoin Sodium is prescribed for the treatment and management of acute convulsive disorders:

  • Status Epilepticus: It is used to control generalized tonic-clonic status epilepticus, a medical emergency characterized by prolonged or back-to-back seizures.
  • Seizure Prevention in Neurosurgery: It is administered to prevent and treat seizures during or following neurosurgical procedures.
  • Short-Term Oral Substitution: It serves as a temporary injection-based substitute for oral phenytoin when patients cannot take medications by mouth.

Why Manufacturers Choose Fosphenytoin Sodium

Fosphenytoin Sodium is a high-value molecule for third party manufacturing in India due to its critical role in emergency medicine and critical care units. Its superior solubility and safety profile over classic intravenous phenytoin have made it the preferred clinical choice globally, driving strong demand for export markets and institutional government tenders.

For pharmaceutical distributors and export-oriented companies, sourcing Fosphenytoin Sodium injection from WHO-GMP certified partner facilities ensures strict compliance with global pharmacopoeial standards. Sourcing this specialized injectable enables portfolio expansion into high-barrier therapeutic segments, backed by reliable supply chain logistics. This makes Fosphenytoin Sodium one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Injection
50mg PE/ml

Frequently Asked Questions

What is the minimum order quantity for Fosphenytoin Sodium?
Minimum order quantity for Fosphenytoin Sodium is Contact us for MOQ — varies by strength and dosage form. Please contact us for bulk pricing and custom quantities.
What dosage forms of Fosphenytoin Sodium can you manufacture?
We manufacture Fosphenytoin Sodium as: Injection (50mg PE/ml).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Fosphenytoin Sodium for export?
Yes. We provide export-ready Fosphenytoin Sodium formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Fosphenytoin Sodium?
We manufacture Fosphenytoin Sodium to IP, BP, USP pharmacopoeial standards.
Third Party Manufacturing

Get Fosphenytoin Sodium made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Vials, ampoules. Packaging customized to client brand guidelines.

Start Manufacturing Fosphenytoin Sodium Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Fosphenytoin Sodium across all dosage forms. PCD franchise and export orders welcome.

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