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Safinamide bulk supplier for pharma manufacturers

Safinamide 50 mg ,100 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 50 mg ,100 mg

Reference Brands: Xadago (USA/EU)

Category: Neurology

Safinamide is a Neurology product available as Tablets in strengths 50 mg ,100 mg. It corresponds to the reference brand Xadago (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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Product Description:

Safinamide is a medication used in the management of idiopathic Parkinson’s disease in adults who experience motor fluctuations, commonly known as “off” episodes. It is marketed under the brand name Xadago and is prescribed as an add-on therapy for patients receiving a stable dose of levodopa, either alone or in combination with other Parkinson’s disease treatments. Safinamide is particularly beneficial for patients whose symptoms re-emerge when the effects of levodopa wear off.

Safinamide has a unique and multi-modal mechanism of action. It acts as a selective and reversible inhibitor of monoamine oxidase B (MAO-B), an enzyme responsible for the breakdown of dopamine in the brain. By inhibiting MAO-B, safinamide helps increase and prolong dopamine activity, improving motor control. In addition, safinamide modulates abnormal glutamate release, which contributes to both motor and non-motor symptom control.

Safinamide — third party manufacturing & bulk supply

Safinamide 50 mg ,100 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

Indicative minimum order quantity

Safinamide 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 Safinamide 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

Safinamide is used as an add-on treatment to levodopa, alone or in combination with other Parkinson’s disease medications, to manage motor fluctuations in adults with Parkinson’s disease.

Safinamide is a synthetic small-molecule compound developed to selectively inhibit MAO-B and modulate abnormal glutamate release in the brain.

The trade name of safinamide is Xadago.

Safinamide (Xadago) is marketed by Newron Pharmaceuticals, with commercialization partnerships in various regions.

The generic name is safinamide mesylate.

The brand name is Xadago.

Safinamide is manufactured by authorized pharmaceutical manufacturing partners supplying the USA, EU, and UK markets under regulatory approval.

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