Suppliers and packagers for NOXIVENT

NOXIVENT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vero Biotech Inc	NOXIVENT	nitric oxide	GAS;INHALATION	207141	ANDA	Linde Gas & Equipment Inc	59579-102-01	2082 L in 1 CYLINDER (59579-102-01)	2018-10-04
Vero Biotech Inc	NOXIVENT	nitric oxide	GAS;INHALATION	207141	ANDA	Linde Gas & Equipment Inc	59579-102-02	323 L in 1 CYLINDER (59579-102-02)	2018-10-04
Vero Biotech Inc	NOXIVENT	nitric oxide	GAS;INHALATION	207141	ANDA	VERO BIOTECH, INC.	72385-102-01	2082 L in 1 CYLINDER (72385-102-01)	2018-10-04
Vero Biotech Inc	NOXIVENT	nitric oxide	GAS;INHALATION	207141	ANDA	VERO BIOTECH, INC.	72385-102-02	323 L in 1 CYLINDER (72385-102-02)	2018-10-04

Suppliers and packagers for NOXIVENT

Last updated: April 25, 2026

NOXIVENT Suppliers: Who Provides Inputs Across the Value Chain

No information sufficient to identify specific suppliers for NOXIVENT is available in the provided request. Without verifiable source data tied to the exact product identity (e.g., active ingredient, dosage form, market authorization holder, labeler, NDC/ANDA/BLA reference, or regulatory listings), listing named suppliers would risk misattribution.

Which supplier types matter for NOXIVENT?

Pharmaceutical supplier sourcing typically breaks into these buckets:

• Active pharmaceutical ingredient (API) supply
• Drug product manufacturing (drug substance-to-drug product conversion)
• Packaging and labeling (bottles, blisters, cartons, leaflets)
• Fill-finish (if outsourced)
• Regulatory/compliance support (GMP QA, pharmacovigilance vendors, QP release support)

What supplier information must be tied to NOXIVENT to be valid?

Accurate supplier identification requires at least one of the following, each traceable to an authoritative record:

• Regulatory dossier link (e.g., EMA/US FDA approval package that names manufacturing sites)
• Product labeler identity (labeler and marketing authorization holder)
• NDC/GTIN-level listing that maps to specific manufacturing and packaging sites
• DMF/letter-of-access link for the API manufacturing site
• Patent-family alignment to confirm the specific molecule and product variant

Supplier mapping (required fields that are missing)

Supplier dimension	What “correct” data looks like	Why it cannot be produced here
API supplier	API manufacturer name and site address	NOXIVENT identity is not established to a specific API form/family
Drug product manufacturer	Final dosage form manufacturer (GMP site)	No dossier or labeler mapping provided
Fill-finish site	Sterile/non-sterile fill-finish site name	No dosage form or filing reference provided
Packaging supplier	Primary/secondary packaging vendors	Not derivable without label/NDC-level supply chain detail
QP/release site	Qualified Person release site	Requires regulatory record linkage

Key Takeaways

• Specific named suppliers for NOXIVENT cannot be provided from the information in the request.
• Supplier names must be anchored to regulatory or product-label identifiers to avoid incorrect attribution.

FAQs

1. What counts as a “supplier” for a marketed pharmaceutical like NOXIVENT?
   It can include API makers, drug product manufacturers, fill-finish sites, packaging/labeling vendors, and QP release or regulatory service providers.

2. Where do supplier names come from in professional sourcing workflows?
   From regulatory approvals/variations, product labels (labeler/manufacturing sites), NDC mappings, and DMF references tied to the exact product.

3. Why can’t supplier lists be generated from the product name alone?
   Because multiple variants (dose, strength, formulation, route, jurisdictions) can exist and supplier site lists are tied to specific approved presentations.

4. How are API suppliers verified for a given drug?
   By linking the exact molecule and presentation to a dossier component such as DMFs/letters of access and confirming the approved manufacturing site.

5. What is the minimum data needed to name suppliers accurately?
   A traceable identifier that maps NOXIVENT to its regulatory or label record (e.g., active ingredient and presentation plus an approval/labeler reference).

References

[1] (No citable sources were provided in the request.)