Last Updated: June 24, 2026

Suppliers and packagers for NOXAFIL


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NOXAFIL

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596 NDA Merck Sharp & Dohme LLC 0085-4331-01 1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS 2014-03-13
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003 NDA Merck Sharp & Dohme LLC 0085-1328-01 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS 2006-09-15
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003 NDA AUTHORIZED GENERIC ENDO USA, Inc. 0254-1016-36 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS 2023-03-29
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053 NDA Merck Sharp & Dohme LLC 0085-4324-02 60 TABLET, COATED in 1 BOTTLE (0085-4324-02) 2013-11-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for NOXAFIL

Last updated: May 28, 2026

NOXAFIL suppliers: who manufactures posaconazole and supplies the drug (US and major EU channels)

Executive summary: NOXAFIL is posaconazole in oral suspension (delayed-release and re-formulations), gastro-resistant tablets, and IV infusion (if launched in-country). The supplier landscape is split between (1) drug substance and drug product manufacturing, (2) marketing authorization holders and regional distributors, and (3) specialty pharmacy and hospital procurement channels. No supplier-specific answer can be produced from the information provided.

What suppliers make NOXAFIL (posaconazole) drug product and drug substance?

No supplier-specific mapping of NOXAFIL manufacturing sites or API sources can be generated without authoritative identifiers (for example, labeled manufacturers on the US package insert, EMA product details, or FDA Drug Establishment Data tied to NOXAFIL NDCs).

Which NDCs map to which NOXAFIL formulations and manufacturers?

A complete supplier answer requires:

  • NDC-by-formulation linkage (oral suspension vs delayed-release tablets vs IV formulation where approved)
  • labeled manufacturer and packager on the specific dosage form
  • cross-reference to FDA “Drug Establishment Registration and Listing” (or EMA manufacturing authorisations)

Which API suppliers provide posaconazole used in NOXAFIL?

API sourcing is typically not fully visible in consumer-facing materials. Mapping requires:

  • site-level manufacturing registrations and
  • API manufacturer listings tied to specific establishments or marketing-authorisation documentation.

What companies supply NOXAFIL to hospitals and specialty pharmacies?

Hospital and specialty supply chains depend on:

  • wholesaler distribution (typically national wholesalers plus specialty intermediaries)
  • group purchasing organization (GPO) contracting
  • NDC-specific allocation during shortages.

A credible list requires NOXAFIL-specific procurement contract identifiers or supplier-of-record data by channel.

Which suppliers handle NOXAFIL in the US market (FDA-regulated channel)?

US market supplier visibility generally comes from:

  • the approved labeling section that lists manufacturer, and
  • FDA establishment registrations tied to the marketed product NDC(s).

With only the drug name provided, supplier-of-record cannot be determined.

What suppliers cover NOXAFIL in Europe (EMA authorization and regional distribution)?

EU supplier roles depend on:

  • marketing authorisation holder (MAH) by country,
  • local packaging sites,
  • national wholesale distribution and tender awards.

A country-by-country supplier list requires EMA product pages and national dossier information linked to the exact dosage form.

How does NOXAFIL supply differ by formulation (oral suspension vs tablets vs IV)?

Supply chains diverge because:

  • tablet manufacturing uses different dosage-form equipment and solid-state lines
  • oral suspension has suspension fill-finish complexity and different component sourcing
  • IV requires sterile manufacturing and additional cold-chain or sterile supply constraints.

A formulation-specific supplier set cannot be produced without mapping each NOXAFIL presentation to its labeled manufacturers and establishments.

What generic or biosimilar-like competition affects NOXAFIL supplier choices?

Posaconazole competition is driven by:

  • generic oral formulations and
  • changes in reference product manufacturing under supply agreements.

A supplier-shift assessment requires visibility into manufacturing continuity and any shortages or contract manufacturing changes, which are not provided.

Who are the likely NOXAFIL manufacturing partners (CDMO logic) and what barriers exist?

A manufacturing-partner profile requires:

  • establishment registration patterns by dosage form and
  • evidence of contract manufacturing (CDMO) in labeling or public regulatory records.

No data is available in the prompt to connect NOXAFIL to specific CDMOs.

Key Takeaways

  • NOXAFIL suppliers split across drug substance, drug product manufacturing, marketing authorisation/distribution, and channel procurement.
  • A supplier list cannot be generated accurately from the single input “NOXAFIL” without dosage-form-specific product identifiers and linked regulatory manufacturing data.

FAQs

  1. Which NDCs correspond to NOXAFIL oral suspension, delayed-release tablets, and IV?
  2. How do I verify NOXAFIL manufacturer and packager from FDA labeling and establishment records?
  3. Do posaconazole API suppliers differ from NOXAFIL drug product manufacturers?
  4. Which factors drive hospital contracting changes for NOXAFIL during supply constraints?
  5. What EMA and national regulatory sources list NOXAFIL manufacturing sites in EU countries?

References

  1. No sources cited.

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