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

NAYZILAM (midazolam nasal spray) Suppliers: Who Manufactures, Fills, and Supplies the Product for U.S. Launch and Broader Distribution

Last updated: May 31, 2026

NAYZILAM (midazolam nasal spray, C-IV) is supplied in the U.S. under the U.S. label by Neuraxpharm Inc. (formerly known as Neuraxpharm US, a Janssen/Neuraxpharm-related brand operator). The product is manufactured via contract manufacturing and fill-finish supply chains tied to midazolam nasal dosage-form know-how. Public, regulator-linked supplier identity for every step (drug substance vs. drug product, primary packaging, secondary packaging) is not fully exposed in one place for all jurisdictions.

Who are the key NAYZILAM suppliers for manufacturing and supply?

Answer: The public-facing “supplier” profile for NAYZILAM is anchored on the U.S. label holder (Neuraxpharm Inc.) and the underlying contract manufacturing and fill-finish network disclosed through FDA labeling and regulatory filings. The specific named manufacturers for each production step are not consistently enumerated in a single public artifact.

What does “supplier” mean for NAYZILAM in regulatory terms?

For drug supply chain purposes, “supplier” typically maps to:

• Label holder / distributor (U.S. party responsible for distribution under the NDC label)
• Manufacturer of drug substance (API), if disclosed
• Manufacturer of drug product (fill-finish and finishing)
• Packager and labeler (primary container, cartons, kits)

For NAYZILAM, the most operationally relevant supplier entities are those that appear on the U.S. label and FDA-reviewed packaging/manufacturing sections.

What is the most reliable public source to identify NAYZILAM suppliers?

The most direct public sources are:

• FDA drug label (Highlights + section “How Supplied/Storage” and manufacturing information blocks)
• FDA Orange Book listing for the NAYZILAM NDC (lists application/holder, not always all manufacturers)
• CMC sections and FDA review documents (often not fully indexed for supplier names)

What does the FDA label say about NAYZILAM manufacturer and distributor entities?

Answer: The FDA label identifies the U.S. label holder/distributor and the parties associated with manufacturing and packaging in the “Manufactured for” / “Distributed by” and “How Supplied” blocks. This is the only source that usually provides step-level party naming that can be used for supplier onboarding and due diligence.

NAYZILAM label holder and U.S. distribution

The U.S. label for NAYZILAM lists Neuraxpharm Inc. as the U.S. distributor/label holder entity (source: FDA label).

How to interpret “Manufactured for” vs “Distributed by”

• Manufactured for generally indicates the party that paid for or is the named label-holder customer of the contract manufacturer.
• Distributed by indicates who is accountable for distribution in the U.S. under the label.

Which contract manufacturing and fill-finish suppliers support midazolam nasal spray?

Answer: NAYZILAM is produced using a contract manufacturing and packaging network typical of nasal spray CMC. The exact list of contract manufacturers changes by site, and public visibility varies across submissions.

What steps in a nasal spray supply chain matter for supplier selection?

• API sourcing and grade compliance for benzodiazepines
• Formulation and spray pump performance testing
• Sterility/bioburden and container-closure integrity (for the nasal product)
• Primary packaging assembly (unit dose delivery system)
• Secondary packaging (cartons, patient instructions, tamper-evident packaging)

Does NAYZILAM have multiple NDCs that imply multiple suppliers?

Answer: Multiple NDC presentations can map to different packaging configurations and can involve different contract packaging sites. Without pulling the specific NDC-by-NDC label manufacturing blocks, the public supplier list cannot be exhaustively enumerated.

What NDC-level differences can change supplier identity?

• Different pack sizes
• Different cartons and labeling formats
• Different distribution channels (institutional vs retail)
• Different pump/adapter SKUs that drive a distinct fill-finish line

What is the Orange Book status of NAYZILAM and does it affect supplier choices?

Answer: Orange Book status is mainly relevant for generic and market-entry timelines, not for identifying suppliers for the currently approved brand. It does not reliably list each manufacturing site.

How Orange Book helps in supply planning

• Confirms approved presentations and application type
• Supports forecasting for generics/biosimilars and expected competitive pressure
• Links to reference listed drug (RLD) for equivalence planning

Who supplies NAYZILAM to hospitals and specialty channels?

Answer: The channel supplier identity is typically the U.S. label holder/distributor (Neuraxpharm Inc.) or its contracted wholesalers and logistics partners. Supplier onboarding for hospital formularies typically routes through:

• the label holder’s distribution network,
• direct contracts with wholesalers,
• group purchasing organization arrangements.

Public data that names every downstream logistics and specialty channel vendor is not consolidated.

What generic entry risks exist for NAYZILAM suppliers?

Answer: Supplier strategy for NAYZILAM should assume that generic competition can trigger:

• pricing pressure,
• manufacturing-site diversification,
• increased fill-finish and packaging competition.

However, identifying specific generic challengers and their supplier readiness requires a separate, NDC-specific Orange Book and Paragraph IV litigation pull that is not included in the public “supplier” name block.

Key takeaways

• NAYZILAM’s publicly named U.S. supplier/distributor anchor is Neuraxpharm Inc. (from the FDA label).
• Step-level manufacturing and packaging supplier names are typically disclosed in the FDA label’s “Manufactured for” / “Distributed by” blocks and can vary by presentation and packaging configuration.
• For nasal spray supply chains, supplier due diligence should cover API grade control, fill-finish line qualification, pump/container-closure performance, and packaging QA.

FAQs

1) Who is the U.S. distributor of NAYZILAM?

Neuraxpharm Inc. is the U.S. distributor/label holder shown on the FDA label (see FDA label).

2) Are the NAYZILAM suppliers the same across all NDC presentations?

Not necessarily. Different pack sizes and configurations can use different packaging sites even when the label holder stays the same.

3) Does Orange Book list the contract manufacturing sites for NAYZILAM?

Orange Book typically does not list every manufacturing and packaging site. It links to the approved application and RLD, while the FDA label is the primary public source for manufacturer/packager naming.

4) What parts of the NAYZILAM supply chain should procurement validate first?

API compliance for benzodiazepines, nasal spray CMC performance, fill-finish line qualification, and container-closure and packaging integrity.

5) How does generic competition affect NAYZILAM supply risk?

It increases procurement leverage and can drive manufacturing-site diversification and cost competition, but it also increases demand volatility.

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References

1. U.S. Food and Drug Administration. NAYZILAM (midazolam) nasal spray prescribing information. FDA label.
2. U.S. Food and Drug Administration. Drug Products (Orange Book): NAYZILAM (midazolam nasal spray). FDA Orange Book database.