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Dalfampridine bulk supplier for pharma manufacturers

Dalfampridine 10 mg Suppliers & Bulk Manufacturers

Available Forms: Extended-Release tablets (XR)

Available Strengths: 10 mg

Reference Brands: Ampyra(US)

Category: Multiple sclerosis

Dalfampridine ER is a potassium channel blocker that enhances nerve signal conduction in damaged nerves. It improves walking speed and mobility in multiple sclerosis patients. Benefits include better gait, increased independence, and improved quality of life, supporting functional mobility and daily activity performance.

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Product Description:

Dalfampridine extended-release (ER) tablets, marketed as Ampyra, are approved in the US by the FDA and in the EU via EMA for improving walking in multiple sclerosis (MS) patients. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial results and manufacturing standards, while the EMA ensures compliance with regional safety and quality standards. 

Dalfampridine — third party manufacturing & bulk supply

Dalfampridine 10 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

Dalfampridine is supplied as Extended-Release tablets (XR) — 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 Dalfampridine 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

Dalfampridine is listed as Extended-Release tablets (XR) in 10 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Dalfampridine is referenced against Ampyra(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.

Dalfampridine is catalogued under Multiple sclerosis on PharmaTradz. Related products within the same category are listed at the foot of this page.

Submit an RFQ stating your destination market, required quantity and whether you need stock supply, third party manufacturing or dossier licensing. Matched suppliers respond with pricing, MOQ and lead times.

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