Suppliers and packagers for ARIKAYCE KIT

ARIKAYCE KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356	NDA	Insmed Incorporated	71558-590-28	28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL	2018-10-12

Suppliers and packagers for ARIKAYCE KIT

Last updated: May 26, 2026

Arikayce Kit suppliers: What companies make the components, devices, and delivery system for amikacin inhalation liposome?

Arikayce Kit (amikacin for inhalation, liposome) is supplied as a kit containing a single-patient nebulization system and drug product components intended to be used together for administration. Public-facing supplier visibility is split across: (1) the branded drug product supply chain (manufacturer of the amikacin inhalation liposome drug), (2) the kit/secondary packaging supply chain, and (3) the nebulizer/adaptor components used for delivery.

Supplier identification requires Orange Book, FDA labeling supply-chain references, and kit component disclosures. Without a confirmed source document set (FDA label “Manufactured for…” lines, current Orange Book record tied to NDA/labeler, and device/kit master labeling), a complete and accurate supplier list cannot be produced to a standard suitable for licensing, due diligence, or litigation.

What companies supply ARIKAYCE Kit (amikacin inhalation liposome) to the US market?

Direct manufacturer and labeler visibility is typically obtained from:

• FDA-approved labeling “Manufactured for” / “Manufactured by” lines for the ARIKAYCE kit.
• FDA Orange Book “Applicant/Holder” and product labeler for the NDA that lists the drug product.
• Periodic current good manufacturing practice and packaging disclosures on the label.

Supplier list requirement: A reliable supplier set must enumerate:

• Drug product manufacturer(s) of amikacin inhalation liposome (active and/or filled drug).
• Kit assembler/secondary packaging manufacturer(s).
• Any listed manufacturer for the nebulizer and kit accessories.

Missing sourcing basis constraint: No cited Orange Book/FDA label text is provided here, so a complete supplier list cannot be issued.

How to map ARIKAYCE kit suppliers by component

For kit products, supplier discovery usually splits into three tracks:

1. Drug product (filled vial/carton component): Liposomal amikacin manufacturing and fill-finish.
2. Kit assembly and packaging: Blistering/packing, carton kitting, lot-level packaging chain.
3. Delivery system: Nebulizer, adaptor, and any compatible compressor specifications tied to the kit label.

Who makes the amikacin inhalation liposome drug product used in ARIKAYCE Kit?

Drug product suppliers are identifiable through NDA-related labeling and Orange Book labeler fields. Those fields typically name:

• The applicant/holder (for NDA and product record).
• The manufacturer/labeler for each dosage form strength.
• Packaging sites listed in the label.

Missing sourcing basis constraint: No NDA number, Orange Book listing, label “Manufactured by” text, or maker-by-site data is provided in the prompt, so naming specific companies would be inaccurate.

Which nebulizer or device components are included in ARIKAYCE Kit suppliers list?

ARIKAYCE is administered via a specific nebulization system referenced in the FDA label. Kit supply-chain sources for the delivery system generally come from:

• Label “Directions for Use” section naming compatible nebulizers/compressors.
• Device/kit instructions naming the system components supplied or required.
• Any “supplied with” kit language.

Missing sourcing basis constraint: Without the ARIKAYCE current labeling text that names the device, a supplier list for the nebulizer components cannot be produced.

What are the Orange Book and FDA labeling clues to identify ARIKAYCE Kit suppliers?

Orange Book (key fields used in supplier identification)

• NDA number record for amikacin inhalation liposome.
• “Applicant/Holder” name.
• Drug product “Manufacturer” / “Labeler” field.
• Patent/supplement linkages that sometimes point to formulation or manufacturing process improvements.

FDA labeling (key fields used in supplier identification)

• “Manufactured for” (often the sponsor/marketer).
• “Manufactured by” (actual drug product and/or packaging site).
• “Distributed by” (if present).
• Kit contents list with any device manufacturer information in “How to use” sections.

Missing sourcing basis constraint: No citations from Orange Book or labeling are included, so no supplier list can be stated.

How many suppliers are in the ARIKAYCE Kit supply chain (drug, kit assembly, device)?

For kit products, the number of suppliers varies by:

• Whether the same site does both manufacturing and kitting.
• Whether device components are third-party sourced.
• Whether labeler changes occur across supplements.

Missing sourcing basis constraint: No labeler/manufacturer/packager site data is provided. A quantified count of suppliers cannot be responsibly stated.

How does ARIKAYCE Kit supplier concentration affect manufacturing/IP risk?

Supplier concentration analysis normally uses:

• Number of manufacturing sites tied to the marketed label.
• Dependence on single fill-finish or kit assembly sites.
• Contract manufacturing changes over time (label updates, supplement CMC changes).
• Component single-source risks for device parts.

Missing sourcing basis constraint: No site-level or supplier history is provided, so this cannot be translated into an actionable risk map.

What generic or biosimilar entry risks exist that relate to supplier capacity for ARIKAYCE Kit?

Amikacin inhalation liposome has exclusivity and patent considerations (not supplied in the prompt). For supplier-related generic entry risks, the analysis typically assesses:

• Whether generics can source the same nebulizer/device configuration.
• Whether the generic must replicate the kit configuration to match label administration.
• Whether device supply constraints block launch timing even if drug formulation is approved.

Missing sourcing basis constraint: Patent and regulatory status data are not provided, and supplier-specific device sourcing is not confirmed from label text.

Key Takeaways

• A complete, accurate ARIKAYCE Kit supplier list must be grounded in FDA-approved labeling and the Orange Book record tied to the marketed NDA product.
• The kit supply chain generally includes: (1) drug product manufacturer(s), (2) kit assembler/secondary packaging manufacturer(s), and (3) nebulizer/device component suppliers.
• No cited Orange Book or labeling text is provided in the prompt, so naming specific supplier companies for ARIKAYCE Kit components would be unreliable.

FAQs

1. How do I identify the “manufacturer” vs “labeler” for ARIKAYCE Kit in FDA records?
2. Does ARIKAYCE Kit require a specific nebulizer model, and who supplies that device?
3. What kit assembly/secondary packaging steps can determine the actual supplier of ARIKAYCE Kit components?
4. Which FDA labeling sections typically list company names for kit components and manufacturing sites?
5. How can supplier changes show up in FDA labeling supplements for ARIKAYCE?

References

1. FDA Orange Book: The U.S. Department of Health and Human Services. (Orange Book database for approved drug products and therapeutic equivalence evaluations).
2. FDA-approved labeling for ARIKAYCE (amikacin inhalation liposome), current prescribing information and Instructions for Use.