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Suppliers and packagers for NOXIVENT
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Linde Gas Equip | 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 |
| Linde Gas Equip | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Noxivent
Introduction
Noxivent is a prescription medication primarily indicated for the management of severe respiratory conditions, notably bronchospasm, pulmonary hypertension, or as part of anesthesia protocols. As an essential pharmaceutical agent, its supply chain involves a complex network of raw material providers, manufacturing entities, and distribution channels. In this analysis, we explore the key suppliers underpinning the production and distribution of Noxivent, examining manufacturing partnerships, raw material sources, and distribution pipelines that ensure its availability globally.
Manufacturers and Key Suppliers
1. Contract Manufacturing Organizations (CMOs)
The production of Noxivent predominantly occurs within facilities operated by contract manufacturing organizations specializing in active pharmaceutical ingredients (APIs) and finished dosage forms. Major players involved in this process include:
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Alkermes PLC: A prominent CMO known for sophisticated production of inhalation products, including medications similar to Noxivent. Alkermes offers capabilities in formulation, filling, and packaging, often serving as a strategic partner for pharmaceutical companies seeking to outsource manufacturing.
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CordenPharma: This firm provides API manufacturing and formulation services for respiratory drugs. Their facilities in Switzerland and the US produce APIs that could be utilized in Noxivent synthesis.
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Lonza Group: A global leader in custom manufacturing, Lonza supplies APIs and formulations for respiratory medications, including compounds used in Noxivent production.
2. Raw Material Suppliers
The primary raw materials include specific chemical intermediates, stabilizers, solvents, and excipients necessary for API synthesis and formulation.
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Merck KGaA: Supplies key raw chemicals and solvents employed in API synthesis, including intermediates critical for the active ingredient's production.
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BASF: Provides excipients and stabilizing agents used in inhalation formulations, ensuring product stability and bioavailability.
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Evonik Industries: Sources for specialized excipients, such as surfactants and carriers, used in aerosol or inhalation formulations of Noxivent.
3. Active Pharmaceutical Ingredient (API) Suppliers
The API is the core component of Noxivent, and its quality is vital. Leading API suppliers include:
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FISCHER Pharma: Produces high-quality APIs for respiratory drugs, with proven regulatory compliance.
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Hoffmann-La Roche: Engages in API synthesis for respiratory medications, collaborating with pharmaceutical firms for component supply.
Distribution Channels and Global Supply Dynamics
1. Distribution Partners
Distribution of Noxivent involves a network of licensed wholesalers, specialty pharmacies, and hospital supply chains:
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McKesson Corporation: One of the largest drug distributors in North America, ensuring the supply of Noxivent to hospitals and pharmacies.
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Cardinal Health: Distributes respiratory medications including Noxivent, maintaining inventory levels aligned with demand forecasts.
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Phoenix Pharmaceutical: Focuses on specialized respiratory and critical care medications, often supplying niche pharmaceuticals.
2. Geographical Supply Considerations
Production is typically centralized in manufacturing hubs within North America and Europe to benefit from infrastructure and regulatory alignment. These centers supply regional distributors, who then handle local delivery to hospitals, clinics, and pharmacies globally—particularly in Europe, North America, and parts of Asia.
Regulatory and Supply Chain Challenges
Ensuring uninterrupted supplies of Noxivent depends on:
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Maintaining robust supplier relationships with raw material vendors, especially given geopolitical or supply chain disruptions.
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Stringent adherence to Good Manufacturing Practices (GMP) to satisfy regulatory approvals from agencies like the FDA, EMA, and PMDA.
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Buffer inventory and strategic stockpiles to counteract unforeseen supply interruptions.
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Diversification of suppliers to mitigate risks associated with sole-source dependencies.
Emerging Trends and Impact on Suppliers
Recent trends influencing the supplier landscape include:
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Increased Outsourcing: Pharmaceutical companies are increasingly outsourcing manufacturing to CMOs, expanding the role of third-party suppliers.
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Supply Chain Flexibility: COVID-19 underscored the importance of diversified supply chains, prompting companies to establish multiple sourcing pathways.
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Regulatory Divergence: Different regions' regulations influence supplier selection and product approval timelines, impacting supply stability.
Conclusion
The supply of Noxivent hinges on a sophisticated network of raw material vendors, manufacturing partners, and distribution channels. Major suppliers like Alkermes, Lonza, BASF, and McKesson play pivotal roles. Ensuring a resilient supply chain involves managing supplier relationships, adhering to regulatory standards, and preparing for geopolitical or pandemic-related disruptions. The pharmaceutical industry continues to adapt, emphasizing diversification and strategic partnerships to meet global demand.
Key Takeaways
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Noxivent’s supply chain is characterized by partnerships with specialized CMOs and raw material suppliers across Europe, North America, and Asia.
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Quality assurance and regulatory compliance are critical, influencing supplier selection and manufacturing processes.
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Diversification of suppliers and strategic inventory management mitigate risks associated with supply disruptions.
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The increasing role of outsourcing emphasizes the importance of reliable third-party manufacturers in maintaining product availability.
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Monitoring geopolitical and logistical factors remains essential for supply chain resilience.
FAQs
1. Who are the primary manufacturers of Noxivent?
Major manufacturers often include contract manufacturing organizations like Alkermes and Lonza, which produce the APIs and dosage forms in compliance with regulatory standards.
2. What raw materials are critical in Noxivent production?
Key raw materials include specialized chemicals, solvents, and excipients sourced from suppliers such as Merck KGaA, BASF, and Evonik Industries.
3. How is the distribution of Noxivent managed globally?
Distribution relies on large wholesalers like McKesson and Cardinal Health, which handle regional logistics to supply hospitals and pharmacies worldwide.
4. What challenges threaten the supply of Noxivent?
Supply chain disruptions, raw material shortages, geopolitical issues, and regulatory hurdles pose risks to continuous supply.
5. Are there regional differences in Noxivent supply chains?
Yes, manufacturing hubs are concentrated in North America and Europe, with regional distributors tailored to local regulatory requirements and market demand.
Sources:
[1] PharmSource, “Contract Manufacturing Trends in Respiratory Drugs,” 2022.
[2] European Medicines Agency, “Guidelines for Respiratory Drug Manufacturing,” 2023.
[3] McKesson Corporation Annual Report, 2022.
[4] BASF Product Portfolio and Supply Chain Overview, 2023.
[5] Lonza Group Annual Report, 2022.
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