Suppliers and packagers for generic pharmaceutical drug: nitric oxide

nitric oxide

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	GENOSYL	nitric oxide	GAS;INHALATION	202860	NDA	VERO BIOTECH, INC.	72385-001-01	216 L in 1 CARTRIDGE (72385-001-01)	2019-12-20
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860	NDA	VERO BIOTECH, INC.	72385-002-01	216 L in 1 CARTRIDGE (72385-002-01)	2022-12-28
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860	NDA	VERO BIOTECH, INC.	72385-003-01	73 L in 1 CARTRIDGE (72385-003-01)	2025-06-04
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845	NDA	INO Therapeutics LLC	64693-002-01	1 CYLINDER in 1 CARTON (64693-002-01) / 353 L in 1 CYLINDER	1999-12-23

NITRIC OXIDE Pharma Suppliers: Who Manufactures Gas and Delivery Systems for Hospital Use and How Procurement Works

Last updated: May 23, 2026

Nitric oxide (NO) is supplied as a medical-grade gas through dedicated industrial gas manufacturers and specialty medical gas distributors. In the U.S., routine procurement is typically tied to hospital purchasing contracts for (1) compressed nitric oxide cylinders or (2) nitrogen-balanced nitric oxide delivery systems that integrate gas handling, metering, and safety interlocks for neonatal pulmonary hypertension and related indications.

Scope note: “Nitric oxide” supply in procurement contexts usually means medical nitric oxide gas and the corresponding delivery equipment used in NICUs, plus service/validation components. It does not cover inhaled biologics or tablet/infusion formulations.

Which companies supply medical nitric oxide gas and delivery systems in the US?

Direct answer: Medical nitric oxide delivery in U.S. hospital settings is commonly sourced from large industrial gas players and specialty medical gas suppliers that provide (a) NO cylinders and (b) integrated delivery hardware, calibration, and service contracts.

Common supplier categories

1. Industrial gas manufacturers (medical gases business units)
2. Specialty medical gas distributors (hospital channel)
3. Original equipment manufacturers for NO delivery devices (device channel)
4. Clinical gases service providers (maintenance, replacement parts, device validation)

Typical product forms seen in procurement

• Compressed nitric oxide in cylinders (medical-grade)
• Nitric oxide in nitrogen balance (premixed systems delivered to the device)
• Delivery systems used for neonatal inhaled therapy, including:
  • gas metering and blending
  • continuous monitoring
  • alarms and safety shutoffs
  • workflow consumables (hoses, sensors, filters, calibration components)

Practical procurement mapping (gas vs. device)

Hospitals frequently buy:

• NO cylinders (recurring supply line item), and
• delivery systems (capex or lease), plus
• service contracts (preventive maintenance, sensor replacement, calibration verification, downtime coverage).

This creates a two-vendor procurement model even when the same company sells both.

What delivery-system brands and device suppliers are used with nitric oxide therapy?

Direct answer: The NO delivery market is device-driven in practice because safe dosing requires integrated control, alarms, and monitoring. Hospitals typically standardize on a delivery system platform, then procure nitric oxide gas to match that platform’s requirements.

Device characteristics procurement teams evaluate

• Compatible gas inlet type and pressure range
• Metering accuracy and linearity across dosing range
• Sensor technology for real-time NO/NO2/O2 monitoring
• Alarm setpoints, failsafes, and emergency shutoff
• Data logging and integration with NICU workflow
• Consumables and service availability (lead times, service level terms)
• Cleaning and decontamination procedures for throughput and compliance

How supplier lock-in happens without a “patent tie”

Even where multiple gas sources exist, delivery systems can create operational lock-in because:

• the device has specific cylinder adapters or premix configurations
• hospital SOPs rely on validated dosing behavior
• service contracts are often tied to the installed base

Are there FDA-approved nitric oxide products, and how does that affect suppliers?

Direct answer: FDA approval affects who can market nitric oxide for medical use, and hospitals must procure NO from sources that support compliant labeling, traceability, and lot release.

Regulatory pathway implication for sourcing

In procurement terms, approved products and labeling drive:

• allowable indications (neonatal pulmonary hypertension context)
• dosing instructions and safety monitoring requirements
• device compatibility statements

Where manufacturers show up in hospital purchasing

Supply agreements usually reference:

• product SKU and cylinder size
• nominal concentration
• lot and expiration handling terms
• device compatibility documentation

What supplier roles exist in the nitric oxide supply chain?

Direct answer: Nitric oxide sourcing is usually a three-layer supply chain: upstream gas production, distribution and logistics, and device integration/service.

Upstream: production and filling

• gas production at bulk sites
• cylinder filling, pressure testing, and lot documentation
• medical-grade quality control and batch release

Middle: distribution and logistics

• cold-chain is typically not required, but logistics controls are
• cylinder handling, return policies, and exchange programs
• scheduled deliveries linked to hospital administration units

Downstream: hospital integration and compliance

• delivery system installation and validation
• staff training for dosing and monitoring workflow
• ongoing service and calibration

Which procurement risks matter for nitric oxide suppliers?

Direct answer: NO procurement risk centers on cylinder availability, lead times, device compatibility, and service responsiveness during NICU demand spikes.

Key risks and operational mitigations

• Cylinder supply interruptions: dual-source arrangements by hospital system
• Device downtime: service-level agreements with rapid repair or loaner units
• Compatibility mismatches: validated adapters, premix configurations, and SOP controls
• Regulatory/traceability compliance: lot-level documentation for audit readiness
• Training drift: refresher training tied to staff turnover and device firmware/software updates

How do nitric oxide supplier contracts typically price and structure?

Direct answer: Contracts commonly separate recurring gas supply (per cylinder or exchange program) from delivery system ownership/lease and service coverage.

Pricing structures seen in practice

• Per-cylinder pricing with exchange credits
• Service bundle pricing: preventive maintenance + sensor replacement cadence
• Device lease plus consumables and service
• Volume-based tiers by facility count or annual use

Contract clauses that materially affect procurement

• minimum order quantities
• delivery lead times and emergency replenishment terms
• cylinder return logistics and credit terms
• service response time and downtime penalties
• substitution terms if the delivery system is temporarily out of service

How does nitric oxide supplier competition compare to other respiratory inhalation therapies?

Direct answer: Nitric oxide competes on supply reliability, device ecosystem, and service coverage more than on clinical differentiation because its mechanism is gas-phase delivery and the hospital requirement is safety and monitoring.

Comparison points for decision-makers

• Other inhaled therapies often compete via drug formulation and dosing regimens
• NO procurement is influenced heavily by cylinder logistics, device compatibility, and service reliability
• Switching costs come from device validation and staff training

What does a “best fit” supplier evaluation look like for hospitals?

Direct answer: Evaluation should be centered on operational continuity: availability, lead times, device compatibility coverage, and service execution.

Supplier scorecard elements

• cylinder availability and historical fill rate
• average and worst-case lead times
• breadth of device compatibility (or readiness to support the installed base)
• service contract performance (response times, first-time fix rate)
• documentation quality (lot traceability and audit readiness)
• supply chain resilience (secondary sourcing plans)

Key Takeaways

• Nitric oxide supply is a medical gas and delivery-system ecosystem, not a single-product, single-vendor procurement.
• Hospitals commonly buy nitric oxide cylinders (or nitrogen-balanced premix) and procure delivery equipment and service contracts on separate terms.
• Supplier selection is driven by continuity of supply, device compatibility, and service responsiveness during NICU demand surges.

FAQs

1. How do hospitals source nitric oxide cylinders if the delivery device is leased?
   Typically the hospital keeps the installed delivery system and contracts NO gas separately to match required cylinder adapters and validated dosing configuration.

2. What logistics terms matter most for nitric oxide cylinder supply contracts?
   Delivery lead times, emergency replenishment provisions, cylinder return/exchange credits, and lot traceability requirements.

3. Can hospitals dual-source nitric oxide without changing their delivery system?
   Dual sourcing is usually feasible when cylinders or premix formats match the delivery system’s approved inputs and the hospital’s validated SOPs.

4. What usually causes nitric oxide therapy interruption risk in procurement?
   Cylinder availability gaps, mismatched cylinder adapters, or device downtime when service coverage does not include rapid repair or loaner support.

5. Do nitric oxide suppliers also provide device installation and ongoing calibration support?
   In most hospital procurement models, gas suppliers and device/service providers are bundled via contracts or integrated through a single vendor ecosystem, but device service can also be sourced separately.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drug Approval Reports and Labeling for nitric oxide products. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. FDA. Drug Safety and Availability and labeling resources. FDA. https://www.fda.gov/drugs/drug-safety-and-availability