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Opicapone bulk supplier for pharma manufacturers

Opicapone 25 mg, 50 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 25 mg, 50 mg

Reference Brands: Ongentys (USA/EU)

Category: Neurology

Opicapone is a Neurology product available as Capsules in strengths 25 mg, 50 mg. It corresponds to the reference brand Ongentys (USA/EU). 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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📘 Sourcing Guide

Product Description:

Opicapone, marketed under the brand name Ongentys, is a peripherally acting catechol-O-methyltransferase (COMT) inhibitor used as adjunctive therapy with levodopa in patients with Parkinson’s disease. It is specifically indicated for individuals experiencing “off” episodes, where the effects of levodopa wear off before the next dose, leading to a return of motor symptoms.

Opicapone works by inhibiting the COMT enzyme in the peripheral tissues, which is responsible for the breakdown of levodopa in the body. By blocking this enzyme outside the brain, opicapone enhances and prolongs the availability of levodopa, allowing more of it to reach the central nervous system where it is converted into dopamine. Importantly, opicapone does not inhibit COMT within the brain, contributing to its targeted peripheral action.

As a result of sustained levodopa levels, dopamine concentrations in brain regions responsible for movement and coordination are better maintained. This leads to improved control of Parkinson’s disease symptoms such as stiffness, slowness of movement, and reduced mobility. With its once-daily dosing and long-lasting COMT inhibition, opicapone provides a convenient and effective option for optimizing levodopa therapy in Parkinson’s disease management.

Opicapone — third party manufacturing & bulk supply

Opicapone 25 mg, 50 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Opicapone listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Opicapone is used as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience end-of-dose “off” periods.

Opicapone is a synthetic small-molecule COMT inhibitor designed to act peripherally without significant central nervous system penetration.

The trade name of opicapone is Ongentys.

Opicapone (Ongentys) is developed and marketed by BIAL – Portela & Cª, S.A.

The generic name of Opicapone is opicapone.

The brand name of Opicapone is Ongentys.

Opicapone is manufactured in EU-based and other GMP-approved global facilities, depending on the market and supply chain.

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