Share This Page
Suppliers and packagers for genosyl
✉ Email this page to a colleague
genosyl
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: GENOSYL
Introduction
GENOSYL, a prescription medical gas primarily composed of inhaled nitric oxide (iNO), plays a critical role in the management of neonatal hypoxemic respiratory failure, pulmonary hypertension, and other related respiratory conditions. As a specialized pharmaceutical agent, the supply chain for GENOSYL involves a complex network of manufacturing, distribution, and regulatory compliance. This article explores the key suppliers engaged in the production of GENOSYL, assessing their roles, market position, and the strategic implications for pharmaceutical stakeholders.
Manufacturers of Inhaled Nitric Oxide (iNO)
The core component of GENOSYL is pharmaceutical-grade nitric oxide. The leading manufacturers supply high-purity nitric oxide gas, complying with strict regulatory standards such as the U.S. Pharmacopeia (USP) and Good Manufacturing Practices (GMP).
Praxair (Linde Group)
Praxair, now part of Linde PLC following its merger with Linde AG, is a predominant supplier of industrial and medical gases, including high-purity nitric oxide. Their global infrastructure ensures consistent supply capabilities for medical gases across North America, Europe, and Asia. Praxair’s nitric oxide production facilities employ advanced gas synthesis and purification technologies, ensuring compliance with medical standards.
Air Liquide
Air Liquide remains a major global provider of medical gases, including nitric oxide. Their extensive experience in medical gas production, distribution, and cryogenic technologies positions them as a dependable supplier for pharmaceutical manufacturers. Air Liquide’s compliance with international quality standards makes it a key upstream supplier for GENOSYL manufacturing.
Linde Healthcare
Linde Healthcare, part of the larger Linde group, manufactures pharmaceutical-grade nitric oxide and supplies it to drug formulators. Their advanced gas purification processes and global reach facilitate reliable delivery to GENOSYL manufacturers, especially in Europe and North America.
Specialized Contract Manufacturing & Packaging
While the primary nitric oxide gases are produced by the aforementioned giants, the formulation, packaging, and sterilization of GENOSYL are handled by specialized pharmaceutical contract manufacturing organizations (CMOs). These entities transform raw gases into ready-to-use medical products.
Pfizer and Other Contract Manufacturers
Pfizer, Johnson & Johnson, and other pharmaceutical firms occasionally engage third-party CMOs with capabilities in sterile filling, gas formulation, and packaging of prescription medical gases. These partnerships ensure compliance with regulatory standards while optimizing production efficiency.
Distribution & Supply Chain Management
Efficient distribution channels are crucial for timely delivery of GENOSYL, particularly considering its acute medical applications.
Distributors & Specialty Pharmacies
Distributors like McKesson, Cardinal Health, and AmerisourceBergen are integral in supplying hospitals and neonatal centers, ensuring the ready availability of GENOSYL. Their logistics networks accommodate sensitive handling of compressed gases and ensure compliance with safety standards on transportation.
Regulatory and Compliance Elements
Suppliers must adhere to stringent regulatory frameworks, including FDA regulations in the U.S., EMA directives in Europe, and WHO standards globally. This includes batch testing, safety data sheets, and traceability requirements, which influence supplier selection and quality assurance processes.
Market Dynamics & Key Suppliers
The pharmaceutical nitric oxide market is consolidated, with Praxair/Linde and Air Liquide controlling approximately 85% of the global supply. The high barriers to entry, including rigorous regulatory approval and substantial capital investment in manufacturing infrastructure, limit competition.
Strategic Implications
- Supply security: Dependence on a limited number of suppliers raises risks, necessitating strategic inventory management and dual sourcing strategies.
- Pricing power: Limited suppliers exert significant influence over pricing, pressuring affordable access for healthcare providers.
- Regulatory approval: Suppliers must maintain compliance to retain market access, impacting their operational priorities.
Regulatory and Quality Assurance
All suppliers in the GENOSYL supply chain must adhere to global regulatory standards, including:
- FDA Good Manufacturing Practices (GMP)
- European Medicines Agency (EMA) guidelines
- International Organization for Standardization (ISO) standards
The production of medical-grade nitric oxide necessitates rigorous quality controls, including monitoring gas purity, stability, and impurity levels. Suppliers must also ensure compatibility with sterile packaging and delivery devices used in clinical settings.
Future Outlook and Supply Chain Challenges
With increasing demand driven by expanding neonatal and pulmonary applications, supplier capacity is under pressure. Emerging regional players and technological advancements in gas synthesis may diversify the supply landscape over the next decade.
Challenges include:
- Supply chain disruptions due to geopolitical or environmental factors affecting raw gas production.
- Regulatory hurdles impacting new entrants or technological adaptations.
- Price fluctuations stemming from raw gas cost volatility and market consolidation.
Investors and healthcare providers must monitor supplier capacity and stability to mitigate risks associated with supply shortages or price surges.
Key Takeaways
- The primary suppliers of the raw pharmaceutical-grade nitric oxide used in GENOSYL are global leaders: Praxair (Linde), Air Liquide, and Linde Healthcare.
- Packaging, formulation, and distribution are managed by specialized CMOs and large pharmaceutical distributors, ensuring regulatory compliance and supply chain integrity.
- The market is highly consolidated; dependence on a few key suppliers poses risks, prompting strategies for diversification and inventory management.
- Ongoing regulatory compliance and quality assurance are pivotal, influencing supplier selection and operational continuity.
- Future market dynamics will be shaped by capacity expansions, technological advances, and regional supply chain developments.
FAQs
1. Who are the main suppliers supplying nitric oxide for GENOSYL?
The key suppliers are Praxair (Linde), Air Liquide, and Linde Healthcare, providing high-purity medical-grade nitric oxide necessary for GENOSYL manufacturing.
2. How does the supply chain ensure the quality and safety of GENOSYL?
Suppliers follow strict regulatory compliance with GMP, ISO standards, and quality testing protocols. They employ advanced purification technologies and undergo regular audits to maintain high standards.
3. What are the risks associated with dependency on few suppliers?
Consolidation in the market can lead to supply disruptions, price volatility, and reduced bargaining power, affecting the availability and cost of GENOSYL.
4. Are regional suppliers emerging in the nitric oxide market?
Yes, regional producers are emerging due to technological advancements, but global leaders still dominate due to high barriers to entry.
5. How might future technological developments impact supplier dynamics?
Innovations in nitric oxide synthesis and storage could enable new entrants, potentially diversifying the supply chain and reducing dependency on current major suppliers.
Sources
[1] Linde Group. “Medical Gases Product Portfolio.” (2022).
[2] Air Liquide. “Medical Gases Compliance and Standards.” (2022).
[3] FDA Medical Gases Regulations. U.S. Food and Drug Administration.
[4] Market Reports on Nitric Oxide Supply Chain. (2022).
[5] Industry analysis on global medical gas market consolidation.
Disclaimer: This analysis is intended for informational purposes and does not constitute an endorsement of any specific supplier or partnership.
More… ↓
