Fosphenytoin sodium bulk supplier for pharma manufacturers

Fosphenytoin Sodium Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 50 mg PE/mL (2 mL and 10 mL vials)

Reference Brands: Cerebyx (USA)

Category: Neurology

Fosphenytoin sodium injection is a water-soluble prodrug of phenytoin used for status epilepticus and to prevent or treat seizures during neurosurgery. It can be infused faster than phenytoin and can also be given intramuscularly; doses are written as phenytoin sodium equivalents (50 mg PE per ml). The reference brand is Cerebyx. We quote from GMP-approved manufacturers and confirm document status, lead time and MOQ for each order.

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Product Description:

Fosphenytoin sodium is a water-soluble phosphate ester prodrug of phenytoin developed for intravenous and intramuscular administration. It is rapidly converted to phenytoin in the body and is used in the acute management of seizure disorders, particularly convulsive status epilepticus. Compared to intravenous phenytoin, fosphenytoin offers improved safety and tolerability, with a reduced risk of local tissue injury and cardiovascular complications.

In the United States, fosphenytoin sodium is approved for short-term use, typically for five days or fewer, in the treatment of epilepsy when oral or standard phenytoin administration is not feasible or is contraindicated. This includes clinical situations such as status epilepticus, repeated or cluster seizures, endotracheal intubation, persistent vomiting, or cases where the patient is unresponsive or unable to swallow.

Due to its rapid onset of action and flexible administration routes, fosphenytoin sodium is widely utilized in emergency and critical care settings. Its predictable conversion to phenytoin allows effective seizure control while providing enhanced safety during acute neurological emergencies.

Fosphenytoin Sodium — third party manufacturing & bulk supply

Fosphenytoin Sodium is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Fosphenytoin Sodium is supplied as Injection — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Fosphenytoin Sodium listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Fosphenytoin sodium is used for the treatment of status epilepticus and other acute seizure conditions. It is also used for short-term seizure prophylaxis in neurosurgical patients when oral phenytoin administration is not possible.

Fosphenytoin sodium is a synthetic phosphate ester prodrug of phenytoin. It is designed to be water-soluble and is rapidly converted to phenytoin after intravenous or intramuscular administration.

Fosphenytoin sodium is marketed under trade names such as Cerebyx in the United States and Pro-Epanutin in the European Union and the United Kingdom.

Fosphenytoin sodium was originally developed and marketed by Pfizer. It is also manufactured and supplied by other pharmaceutical companies as generic formulations in various regions.

The generic name is fosphenytoin sodium.

The brand names are Cerebyx and Pro-Epanutin.

Fosphenytoin sodium is manufactured in GMP-approved pharmaceutical facilities in the USA and Europe, with production and distribution aligned to regional regulatory approvals.