Suppliers and packagers for NAYZILAM

NAYZILAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321	NDA	UCB, Inc.	50474-500-15	2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSE	2019-05-17

Suppliers for the Pharmaceutical Drug: NAYZILAM

Last updated: July 31, 2025

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Introduction

NAYZILAM (midazolam) nasal spray is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizure clusters in patients aged 12 years and older. As a fast-acting benzodiazepine, NAYZILAM provides rapid seizure relief and is administered intranasally, making it a critical emergency intervention. Its unique mode of delivery and targeted use have positioned it distinctively within the epilepsy treatment landscape. This article explores the key suppliers for NAYZILAM, examining manufacturing sources, distribution channels, and the potential impact on supply chain stability.

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Manufacturers of NAYZILAM

NAYZILAM was developed and marketed by Neurelis, Inc., a specialty pharmaceutical company focused on developing medications for neurologic disorders. Since its approval in 2019, Neurelis has maintained primary responsibility for the production and supply of NAYZILAM.

Neurelis, Inc.

• Role: Exclusive manufacturer of NAYZILAM.
• Manufacturing Facilities: The company operates manufacturing sites compliant with Good Manufacturing Practices (GMP), critical for ensuring medication quality and safety.
• Capacity and Production: Neurelis has invested in expanding its manufacturing capabilities to meet the global demand, including establishing fill-finish lines specific to intranasal medications. These facilities enable their control over quality assurance and supply consistency.

Global Manufacturing Considerations

While Neurelis is the sole producer in the U.S., their supply chain might involve contract manufacturing organizations (CMOs) for raw materials or components, such as midazolam raw powder, prefilled nasal spray devices, and packaging materials. Several pharmaceutical ingredients—specifically midazolam hydrochloride—are sourced from specialized chemical manufacturers worldwide, primarily in Europe and Asia.

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Distribution Channels and Key Suppliers

NAYZILAM’s distribution involves multiple layers: original manufacturer, authorized distributors, pharmacies, hospital systems, and specialty clinics. The integrity of these channels directly influences availability and supply stability.

Authorized Distributors

Neurelis has established partnerships with international and regional pharmaceutical distributors to ensure broad reach, especially in North America, Europe, and other markets.

• AmerisourceBergen: One of the largest pharmaceutical wholesalers in the U.S., responsible for distributing NAYZILAM to pharmacies and healthcare providers.
• Cardinal Health: Another major U.S. distributor, facilitating access in hospital and clinical settings.
• These distributors source stock directly from Neurelis and serve as critical nodes in the supply chain, enabling rapid distribution in emergency settings.

Wholesale and Regional Suppliers

In global markets, Neurelis collaborates with regional wholesalers and importers. These include local pharmaceutical distributors who often source NAYZILAM through authorized channels, ensuring compliance with regional regulatory requirements.

Component Suppliers

The supply of NAYZILAM depends heavily on raw material suppliers:

• Midazolam Raw Material Suppliers: Key chemical manufacturers in Europe and Asia supply pharmaceutical-grade midazolam hydrochloride. Major players include:

  • Fresenius Kabi (Germany): Noted for producing active pharmaceutical ingredients (APIs) including benzodiazepines.
  • Siegfried AG (Switzerland): An established supplier of midazolam and other APIs.
  • UDP Pharma (India) and Shaanxi Jiaotong University (China): Smaller producers, increasingly involved in midazolam API manufacturing.

• Device and Packaging Suppliers: Companies specializing in nasal spray delivery devices—such as AptarGroup and West Pharmaceutical Services—provide components like spray pumps and septa.

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Supply Chain Challenges and Contingencies

The complexity of global pharmaceutical manufacturing introduces vulnerabilities:

• Raw Material Dependency: Reliance on international suppliers for midazolam API poses risk, especially amid geopolitical tensions and supply chain disruptions.

• Manufacturing Capacity Constraints: Scaling production to meet surging demand, especially during crises like the COVID-19 pandemic or epilepsy awareness initiatives, can lead to shortages.

• Regulatory Compliance: Suppliers and manufacturers must adhere to stringent GMP standards, which sometimes limit rapid scalability.

To mitigate these risks, Neurelis has been investing in expanding manufacturing capacity and establishing multiple supplier relationships for critical components.

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Market and Future Outlook

The demand for NAYZILAM is expected to grow, driven by increased epilepsy awareness and the need for rapid emergency treatments. Neurelis's strategy emphasizes expanding manufacturing capacity and forging new supplier agreements to maintain supply stability.

Emerging biosimilar or generic competitors could influence the supplier landscape if they gain regulatory approval. Currently, NAYZILAM's patent exclusivity and the complexity of nasal spray delivery serve as barriers to generic entry, securing Neurelis's market dominance.

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Key Takeaways

• Neurelis, Inc. remains the primary manufacturer and actor in the NAYZILAM supply chain.
• Raw materials, especially midazolam APIs, originate mainly from European and Asian chemical companies.
• Distribution is managed through major pharmaceutical wholesalers such as AmerisourceBergen and Cardinal Health.
• Supply chain resilience depends on diversified sourcing, manufacturing scalability, and regulatory compliance.
• Market expansion and supply chain strengthening are ongoing priorities to meet rising global demand.

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FAQs

1. Who is the main manufacturer of NAYZILAM?
Neurelis, Inc. is the sole manufacturer responsible for production, quality control, and distribution of NAYZILAM.

2. Where does the raw material midazolam come from?
Major suppliers of midazolam API are European companies like Fresenius Kabi and Siegfried AG, with additional sources in Asia.

3. How is NAYZILAM distributed to healthcare providers?
Through authorized distributors such as AmerisourceBergen and Cardinal Health, which supply pharmacies, hospitals, and clinics.

4. Are there any risks to NAYZILAM's supply chain?
Yes; reliance on international API suppliers, capacity constraints, and regulatory hurdles can impact supply continuity.

5. Is there potential for generic versions of NAYZILAM?
Currently, NAYZILAM holds exclusivity, but future generics could emerge if patent protections expire and bioequivalent products gain regulatory approval.

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References

1. U.S. Food and Drug Administration. NAYZILAM (midazolam) nasal spray, prescribing information. 2019.
2. Neurelis Official Website. About NAYZILAM.
3. Pharmaceutical News and Market Reports. API Suppliers and Manufacturing Trends.
4. Industry analysis reports on pharmaceutical supply chains and API manufacturing, 2022.
5. European and Asian pharmaceutical API manufacturer websites.