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Primidone bulk supplier for pharma manufacturers

Primidone 50 mg , 250 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets, Capsules

Available Strengths: 50 mg , 250 mg

Reference Brands: Mysoline (USA)

Category: Neurology

Primidone is a Neurology product available as Tablets, Capsules in strengths 50 mg , 250 mg. It corresponds to the reference brand Mysoline (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Primidone is a deoxybarbiturate, and it is best understood as three drugs at once: primidone itself has anticonvulsant activity, and it is metabolised to phenobarbital and to phenylethylmalonamide, both of which are also active. Steady-state effect therefore reflects the parent and its metabolites together, and phenobarbital accumulates slowly over days.

Two distinct uses persist. As an antiepileptic it is used in focal and generalised tonic-clonic seizures. Separately, and quite unlike the rest of the barbiturate family, it is a first-line pharmacological treatment for essential tremor, where low doses are often effective and the main obstacle is a pronounced first-dose reaction of sedation, nausea and unsteadiness that can be avoided by starting very low at night.

Sourcing notes. Off patent, inexpensive, established manufacture. One practical point buyers miss: because primidone is metabolised to phenobarbital, some jurisdictions apply controlled-substance handling or reporting to it even though primidone itself is generally unscheduled. Confirm the position in the destination market rather than assuming it follows the parent molecule's own status.

Primidone — third party manufacturing & bulk supply

Primidone 50 mg , 250 mg 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

Primidone is supplied as Tablets, Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 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 Primidone 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

Primidone is used to treat epilepsy, particularly generalized tonic-clonic seizures and focal (partial) seizures. It is also widely prescribed for the management of essential tremor when first-line therapies are not effective or suitable.

Primidone is a synthetic anticonvulsant compound belonging to the barbiturate-related class of antiepileptic drugs. In the body, it is metabolized into phenobarbital and phenylethylmalonamide (PEMA), which contribute to its therapeutic effect.

Primidone is commonly marketed under the trade name Mysoline.

The original branded product Mysoline was developed and marketed by Wyeth. Today, primidone is manufactured and supplied by multiple generic pharmaceutical companies worldwide.

The complete generic name is primidone.

The well-known brand name of primidone is Mysoline.

Primidone is manufactured in several countries, including the USA, UK, and EU member states, by different approved pharmaceutical manufacturers for global distribution.

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