Last Updated: June 8, 2026

Suppliers and packagers for ASMANEX TWISTHALER


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ASMANEX TWISTHALER

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Organon LLC 78206-114-01 1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER 2021-06-01
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Organon LLC 78206-114-02 1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER 2021-06-01
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Organon LLC 78206-114-03 1 POUCH in 1 CARTON (78206-114-03) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER 2021-06-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for ASMANEX TWISTHALER

Last updated: May 28, 2026

Suppliers for Asmanex Twisthaler (mometasone furoate inhalation powder): who makes it, who supplies it, and what to check in contracts

Executive summary: Asmanex Twisthaler is a branded inhaled corticosteroid (ICS) product delivering mometasone furoate as a dry powder. The supply chain is dominated by the commercial drug manufacturer(s) that fill and package Twisthaler units and the device supply for the breath-actuated multi-dose inhaler. The key supplier set to map for procurement, distribution, or licensing diligence is (1) NDA holder/labeler and global brand owner, (2) contract manufacturing and packaging (CMO/CDMO) for the drug product, (3) supplier of the Twisthaler inhaler components (device and subassemblies), and (4) contract suppliers for the inhalation DPI formulation and primary packaging.

Because “suppliers” can mean different roles (marketer, NDA holder, labeler, CMOs, device OEM, or component vendors), a complete supplier list is only possible with the product’s FDA labeling/packaging/manufacturer statements, Orange Book/NDA manufacturing site references, and company disclosures in device or CMO agreements.

Per the operating constraints, no complete or reliably accurate supplier roster can be produced from the information provided.

Who are the drug product suppliers for Asmanex Twisthaler (mometasone furoate)

Answer: Not enough verified data in the prompt to identify specific named CMO/CDMO sites and companies that manufacture and package Asmanex Twisthaler drug product.

What “supplier” means in procurement

  • NDA holder/labeler (responsible party on FDA label)
  • Drug product manufacturer (blend, fill, seal)
  • Packager (cartoning, labeling, unit assembly)
  • Device manufacturer (Twisthaler housing, dose counter mechanism)
  • Component suppliers (foil, blister/packaging films, actuator parts)

Which companies supply the Twisthaler inhaler device (OEM) for Asmanex

Answer: Not enough verified data in the prompt to name the Twisthaler device OEM and subcomponent suppliers.

What to verify in documentation

  • Manufacturer name and address on the device and/or outer carton
  • “Distributed by / Manufactured for” statements
  • Device component lot traceability language
  • FDA label “Manufactured for” entries for strength and dosage form

What does the FDA label list as the manufacturer for Asmanex Twisthaler

Answer: Not enough verified data in the prompt to report the FDA label’s listed manufacturers and packing sites for this specific dosage form (inhalation powder, Twisthaler).

Where supplier facts typically appear

  • Outer carton label and package insert “Manufactured for” / “Distributed by”
  • Current labeling revision references
  • NDC-specific labeling pages in the FDA labeling repository

How many suppliers typically sit in the Asmanex Twisthaler supply chain

Answer: Not enough verified data in the prompt to quantify supplier counts for this product.

Typical multi-party structure for DPI + device

  • 1 drug substance upstream supply chain
  • 1 to 2 drug product CMOs (manufacture and fill/finish)
  • 1 packaging CMO (secondary packaging)
  • 1 device OEM plus 1 to 2 subcomponent suppliers

What supplier risks exist for Asmanex Twisthaler (DPI + inhaler device)

Answer: Not enough verified data in the prompt to tie risks to named suppliers for this product.

Common operational risk points to map

  • Device supply interruptions (actuator or dose mechanism components)
  • Packaging material constraints (blister/foil, desiccant, carton stock)
  • DPI formulation stability handling constraints (humidity and particle properties)
  • Regulatory and quality agreements across multiple sites

How does the Asmanex Twisthaler supply network compare with generic mometasone inhalation products

Answer: Not enough verified data in the prompt to compare supplier networks against specific generic entrants.

What comparison requires

  • NDC-level manufacturer listings for each product
  • Site-of-manufacture and packaging differences across strengths
  • Whether generics use the same device architecture or different inhalers

What to check for contract manufacturing and device procurement for Asmanex

Answer: Not enough verified data in the prompt to specify contract manufacturing partners or device procurement terms.

Contract diligence checklist (supplier-facing)

  • Quality agreements and change control responsibilities
  • Site qualification and validation package scope
  • Device and DPI interface specifications
  • Supply continuity clauses and dual-sourcing coverage

Key Takeaways

  • “Suppliers for Asmanex Twisthaler” can include labeler/NDA holder, drug product CMO, packaging CMO, and Twisthaler device OEM.
  • A complete, accurate named supplier roster requires verified product-specific manufacturer and labeler statements.
  • The prompt does not provide those label or regulatory data points, so no reliable supplier list can be produced.

FAQs

  1. What roles are counted as “suppliers” for a DPI like Asmanex Twisthaler?
  2. How do I identify the drug product manufacturer vs the device manufacturer on Asmanex Twisthaler packages?
  3. Where can I confirm the NDC-specific manufacturer information for Asmanex Twisthaler in public records?
  4. What are the most common device-related supply disruptions for breath-actuated inhalers like Twisthaler?
  5. When comparing Asmanex Twisthaler to generic mometasone inhalation powders, what supplier mapping matters most?

References

(No sources cited because the prompt does not include verified label/FDA/regulatory supplier information.)

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