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Pramipexole 0.25 mg Tablet bulk supplier for pharma manufacturers

Pramipexole 0.25 mg Tablet Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: ER tab: 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg; IR Tab: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg

Reference Brands: Mirapex®(US), Sifrol® (EU)

Category: Antipsychotropic Drugs

Pramipexole tablets, immediate-release 0.125-1.5 mg and extended-release 0.375-4.5 mg, a dopamine agonist for Parkinson's disease and restless legs. For importers, distributors and hospital buyers.

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Product Description:

Pramipexole is a non-ergot dopamine agonist that acts on D2 receptors and, with marked preference, on D3 receptors. This page lists immediate-release tablets from 0.125 mg to 1.5 mg, with 0.25 mg a common early strength, and once-daily extended-release tablets from 0.375 mg to 4.5 mg. Watch how strength is written. US labels state the dihydrochloride monohydrate salt, while European labels state the base, so a 0.25 mg salt tablet appears there as 0.18 mg.

Immediate-release tablets are used in Parkinson's disease, alone or with levodopa, and for moderate to severe restless legs syndrome, where one small dose is taken two to three hours before bed. The extended-release tablet is for Parkinson's disease only and is swallowed whole once a day. Pramipexole leaves the body mostly unchanged in urine, so doses are cut when renal function is poor. Prescribers watch for sudden sleep episodes, impulse control disorders and hallucinations. Cimetidine and amantadine, which share its renal transport route, can raise levels.

Sourcing notes. Pramipexole is prescription-only. Request a CTD or ACTD dossier with bioequivalence studies for each release type, plus comparative dissolution profiles for the extended-release tablets. Zone IVb stability data help where heat and humidity are high. Packs should protect from light and moisture, at room temperature. Ask the supplier for a per-batch CoA together with GMP and CoPP certificates. In your enquiry, say whether you need immediate or extended release, whether labels should express salt or base, the pack size and shelf life on arrival.

Pramipexole 0.25 mg Tablet — third party manufacturing & bulk supply

Pramipexole 0.25 mg Tablet 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

Pramipexole 0.25 mg Tablet is supplied as Tablets — 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 Pramipexole 0.25 mg Tablet listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.

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Frequently Asked Questions

Pramipexole is used for the treatment of Parkinson’s disease and restless legs syndrome (RLS). It helps improve motor symptoms such as stiffness, tremor, and impaired movement by stimulating dopamine receptors in the brain.

Pramipexole is a synthetic dopamine agonist. The complete generic name is pramipexole dihydrochloride monohydrate, which is chemically synthesized and not derived from any biological source.

Pramipexole is marketed under trade names such as Mirapex and Sifrol in different global markets.

The original branded versions of pramipexole were developed by Boehringer Ingelheim. Today, it is manufactured by multiple generic pharmaceutical companies worldwide.

The generic name of Pramipexole is pramipexole dihydrochloride monohydrate.

The commonly known brand names of Pramipexole include Mirapex and Sifrol.

Pramipexole is manufactured in various countries including India, the USA, and several European countries by approved pharmaceutical manufacturers.

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