Suppliers and packagers for INOMAX

INOMAX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
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
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845	NDA	INO Therapeutics LLC	64693-002-02	1 CYLINDER in 1 CARTON (64693-002-02) / 1963 L in 1 CYLINDER	1999-12-23
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845	NDA	INO Therapeutics LLC	64693-003-01	78 L in 1 CYLINDER (64693-003-01)	2023-01-17

Suppliers for the Pharmaceutical Drug: Inomax (Nitric Oxide)

Last updated: July 28, 2025

Introduction

Inomax, the branded formulation of inhaled nitric oxide (iNO), is a critical therapeutic agent primarily used to treat neonates and adults experiencing pulmonary hypertension and respiratory failure. As a potent vasodilator, nitric oxide (NO) plays a vital role in decreasing pulmonary artery pressure, improving oxygenation, and reducing the need for extracorporeal membrane oxygenation (ECMO) in vulnerable patient populations. Given its clinical importance, the supply chain for Inomax and its generic counterparts is carefully scrutinized by pharmaceutical companies, healthcare providers, and regulators alike. This article provides a comprehensive overview of the key suppliers involved in manufacturing and distributing Inomax, examining the market landscape, procurement sources, and strategic considerations shaping supply continuity.

Overview of Inomax's Manufacturing and Supply Chain

Inomax (nitric oxide) is produced through specialized manufacturing processes designed to ensure high purity, stability, and safety. The active pharmaceutical ingredient (API), nitric oxide gas, requires stringent handling and storage, given its gaseous state and reactive nature. The final formulation involves dissolving nitric oxide in medical-grade oxygen or air, delivered via specialized ventilators or inhalation devices optimized for clinical settings.

Manufacturers of Inomax are typically located within regulatory jurisdictions such as the United States (FDA-approved), European Union (EMA-approved), and other regions with established pharmaceutical production standards. The complex manufacturing process, coupled with the necessity for strict regulatory compliance, constrains the number of active suppliers capable of meeting quality and safety standards.

Leading Suppliers of Nitric Oxide for Medical Use

1. Linde PLC

Linde PLC is a global leader in industrial gases and has a significant footprint in medical gas production. The company manufactures medical-grade nitric oxide, supplying both branded and generic products to healthcare facilities worldwide. Linde’s advanced production facilities ensure high purity levels, cross-contamination prevention, and consistent supply, making it a primary supplier for several pharmaceutical companies producing Inomax.

2. Air Liquide S.A.

A major player in gases, Air Liquide produces nitric oxide for medical applications through its extensive network of industrial and medical gas plants. Their global reach and quality assurance systems position them as a key supplier, especially to regional pharmaceutical companies aiming for reliable API sources. Air Liquide's nitric oxide is used both directly in clinical settings and as a raw material in manufacturing processes.

3. Praxair Technology Inc. (now part of Linde)

Prior to its acquisition by Linde in 2018, Praxair was a prominent supplier of medical gases, including nitric oxide. Praxair's legacy infrastructure and expertise continue to influence Linde’s operations, ensuring a seamless supply chain for nitric oxide used in hospitals and pharmaceutical manufacturing.

4. AiPharma Inc. (a specialized nitric oxide manufacturer)

AiPharma, a US-based company, focuses exclusively on nitric oxide production tailored to medical applications, especially neonatal and adult pulmonary treatments. Their manufacturing facilities are certified by relevant health authorities, and they supply nitric oxide to several pharmaceutical entities involved in Inomax formulation.

5. Mallinckrodt Pharmaceuticals

Mallinckrodt, a provider of specialty pharmaceuticals, sources nitric oxide from established medical gas manufacturers and supplies the final formulations under their brand or as OEM components for larger pharmaceutical companies. Their supply chain integration ensures timely availability for clinical needs and commercial distribution.

Regulatory and Manufacturing Considerations

The production of nitric oxide for medical purposes is highly regulated. Manufacturing facilities must comply with Good Manufacturing Practices (GMP), ISO standards, and undergo regular inspections by agencies such as the FDA and EMA. These regulations restrict the number of qualified suppliers, favoring those with proven safety, constantly maintained quality systems, and robust supply chains.

Additionally, manufacturing nitric oxide involves advanced gas handling technologies: cryogenic separation, catalytic synthesis, and precise gas blending. The complexity limits new entrants and consolidates existing suppliers who can invest in high-cost, high-technology infrastructure.

Market Dynamics and Supply Challenges

While demand for Inomax remains stable, supply disruptions have occasionally occurred due to:

• Production capacity constraints: Limited facilities capable of manufacturing high-purity nitric oxide.
• Regulatory hurdles: Delays in approvals for manufacturing sites or product modifications.
• Supply chain disruptions: Interruptions in raw material sourcing, logistics, or geopolitical issues affecting global supply chains.
• Price fluctuations: Variations in production costs influence supplier competitiveness and market access.

These factors underscore the importance of diversified supplier relationships and strategic inventory management for healthcare providers and pharmaceutical developers.

Strategic Procurement and Supply Considerations

Pharmaceutical companies manufacturing Inomax or generic nitric oxide formulations typically secure supply agreements with multiple suppliers to mitigate risks. Diversification ensures supply continuity amid fluctuations in capacity, quality concerns, or geopolitical tensions. Furthermore, strategic partnerships with established suppliers like Linde and Air Liquide facilitate compliance with regulatory standards and expedite approval processes.

Healthcare providers and hospitals also engage in long-term supply contracts with primary suppliers, emphasizing the importance of reliability, product purity, and timely delivery. In addition, some companies explore vertical integration—developing in-house nitric oxide manufacturing capabilities—although this approach involves significant capital expenditure and regulatory burdens.

Future Outlook

The nitric oxide market is expected to evolve with increasing demand for pulmonary therapies, especially in neonatal intensive care units (NICUs) and adult respiratory care, fueled by rising cases of pulmonary hypertension and respiratory distress syndrome. Innovations in delivery systems and formulation stability may influence supplier strategies, with an emphasis on aligning manufacturing capacity with clinical needs.

Emerging regional manufacturers from Asia and the Middle East may also enter the market, reshaping the competitive landscape through cost advantages and localized production. However, stringent regulatory oversight remains a barrier en route to market penetration.

Key Takeaways

• Leading suppliers of nitric oxide for Inomax include Linde PLC and Air Liquide, both possessing extensive manufacturing capabilities and regulatory compliance.
• Manufacturing of medical-grade nitric oxide demands sophisticated infrastructure, limiting the number of qualified suppliers globally.
• Supply chain robustness involves diversified supplier relationships, long-term contracts, and strategic inventory management to prevent shortages.
• Regulatory compliance and high-quality manufacturing standards are crucial; suppliers must meet stringent GMP and ISO standards.
• Market dynamics indicate stable demand but highlight vulnerabilities due to capacity constraints and geopolitical factors, necessitating proactive supply chain planning.

FAQs

1. Who are the primary manufacturers of nitric oxide used in Inomax?
Linde PLC and Air Liquide are the dominant global suppliers of medical-grade nitric oxide, producing the API used in Inomax.

2. What regulatory standards must nitric oxide manufacturers meet?
Manufacturers must comply with GMP, ISO standards, and undergo FDA or EMA inspections to ensure safety, purity, and efficacy.

3. Are there alternative suppliers to Linde and Air Liquide?
While other companies like AiPharma and regional producers exist, their capacity and regulatory approval status vary, making Linde and Air Liquide the most relied-upon sources.

4. How do supply chain disruptions affect Inomax availability?
Disruptions can cause shortages, impacting clinical decisions, especially in neonatal care; thus, suppliers and healthcare providers prioritize supply chain resilience.

5. Is there a trend toward local manufacturing of nitric oxide?
Yes, some regions are developing domestic production to reduce dependence on imports, but high-quality requirements and infrastructure costs remain barriers.

References

1. FDA. (2022). Regulatory Guidelines for Medical Gases. U.S. Food and Drug Administration.
2. European Medicines Agency. (2022). Guidelines on Good Manufacturing Practice. EMA.
3. Linde PLC. (2022). Medical Gases Production and Supply. Linde Corporate Website.
4. Air Liquide. (2022). Medical Gases Portfolio and Capabilities. Air Liquide Corporate Website.
5. MarketWatch. (2023). Global Medical Nitric Oxide Market Outlook.

Note: This article is for informational purposes and does not constitute an endorsement or guarantee of supplier capabilities.