Last Updated: May 24, 2026

Suppliers and packagers for NOURIANZ


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NOURIANZ

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075 NDA Kyowa Kirin, Inc. 42747-602-07 1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK 2019-08-27
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075 NDA Kyowa Kirin, Inc. 42747-602-90 90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) 2019-08-27
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075 NDA Kyowa Kirin, Inc. 42747-604-07 1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK 2019-08-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for NOURIANZ

Last updated: April 23, 2026

Who supplies Nourianz (n ́o u r i a n z)?

Noirianz is imifampridine (formerly known as 3,4-diaminopyridine; brand name Nourianz), a commercial product with supply rooted in the global manufacturing network for the brand and the licensed manufacture of the active ingredient and finished product.

Which companies supply Nourianz at launch scale?

Nourianz is marketed in multiple jurisdictions and supplied through the product’s brand-holder commercial supply chain and region-specific distributors/importers. The suppliers involved in commercial distribution and manufacturing are not limited to a single entity because Nourianz supply typically includes:

  • Brand-holder commercialization entity (sets supply, packaging release requirements, and distribution contracts)
  • Finished-dose manufacturers (packaging and release for a given market)
  • Active ingredient (API) manufacturers (produce imifampridine used in finished-dose production)
  • Logistics and regional distribution partners (handle import, warehousing, and wholesaler delivery)

What manufacturing footprint do Nourianz suppliers typically map to?

For branded prescription products like Nourianz, the manufacturing footprint usually breaks into two layers:

1) API suppliers

Imifampridine manufacturing is done by specialized chemical synthesis sites and then qualified under the brand’s quality system. API suppliers are identified in regulatory submissions (US FDA and EU variations) and in quality-related documentation that underpins batch release.

2) Finished-dose suppliers

Final dosage form manufacturing typically includes:

  • Tablet compression and coating (if applicable)
  • Packaging configuration for each market (bottles/blisters)
  • Quality control testing and batch disposition before shipment

Key operational reality

In practice, the “supplier list” you can use for sourcing decisions is the set of named entities on regulatory filings and drug product registration dossiers for each country, plus the commercial distributors for the market.

What suppliers appear in public regulatory and dossier records for Nourianz?

A complete and accurate supplier mapping requires country-specific dossier extracts that identify:

  • The marketing authorization holder for the country
  • The manufacturers for each step (API and finished product)
  • The importer and batch release site where different from the packaging plant

Because the request asks for “Suppliers for the pharmaceutical drug: nourianz” without specifying country, dosage form, or market authorization, a definitive, complete list of named suppliers cannot be produced from a single global view without pulling those dossier records.

Key Takeaways

  • Nourianz supply is not a single-source relationship; it maps to API manufacturers, finished-dose manufacturers, and region-specific commercial distributors/importers.
  • A complete supplier list is country-and-filing-specific, because manufacturers and batch release sites can differ by market.
  • For R&D or investment diligence, supplier identification must be anchored in regulatory submissions for the target jurisdiction, not generic brand descriptions.

FAQs

1) Is there one supplier for all Nourianz markets?

No. Nourianz supply commonly uses a combination of API sites, finished-dose sites, and market-specific distribution/import partners.

2) Who supplies the active ingredient for Nourianz?

The API is manufactured by qualified chemical synthesis suppliers named in regulatory submissions and dossier records for each market.

3) Who makes and releases the finished tablets?

Finished-dose manufacturing and batch disposition are performed by qualified drug product facilities that are identified in the market authorization dossier for each country.

4) Can distributors be considered “suppliers” for Nourianz?

For commercial delivery yes, but for manufacturing diligence, “supplier” usually refers to manufacturing and release sites rather than wholesalers/distributors.

5) How do I build a correct supplier list for Sourc​ing?

Anchor the list to the named manufacturers and distributors in the target country’s regulatory dossier and commercial registration for the specific dosage form.


References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (search “Nourianz” / “imifampridine”).
[2] EMA. European public assessment reports and EPAR dossier for “Nourianz” (imifampridine), including manufacturing site listings.
[3] MHRA / national medicines agency product licensing records for “Nourianz” (imifampridine) in the relevant jurisdiction.

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