Suppliers and packagers for ZURNAI (AUTOINJECTOR)

ZURNAI (AUTOINJECTOR)

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Knoa Pharma	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590	NDA	Knoa Pharma LLC	59011-962-01	1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS	2025-08-07

Suppliers for ZURNAI (autoinjector): Who manufactures the device, drug product, and key subcomponents—and what supply-chain IP risks matter

Last updated: June 10, 2026

ZURNAI (autoinjector) supply-chain sourcing depends on two layers: (1) the drug substance/drug product manufacturing site(s) and (2) the autoinjector system supply chain (device manufacturer plus critical subcomponents such as the spring/needle assembly, cartridge fill interface, and usability/packaging components). Without ZURNAI’s specific FDA label manufacturing details (including listed manufacturer/labeler and any contract manufacturer names) and without ZURNAI’s Orange Book/device listings, a complete supplier map cannot be produced from authoritative records.

No patent- or regulatory-grade supplier identification can be stated here for “ZURNAI (autoinjector)” because the drug’s active ingredient, NDA/abbreviated application number, Orange Book entry, and the FDA label’s “Manufactured for/By” lines are not provided.

If the “ZURNAI” product in your target market is not uniquely identified (by active ingredient and application), any supplier list would be speculative.

Which suppliers manufacture the ZURNAI autoinjector device system?

A defensible supplier breakdown for an autoinjector requires the named device-parties in the FDA label and, when applicable, the device technical file references that appear in the application history. For ZURNAI, supplier identification cannot be completed without the product’s application identifiers and label manufacturer fields.

What autoinjector subcomponents typically come from different suppliers?

Autoinjector supply chains usually separate:

• Pre-filled syringe or cartridge system and elastomer interfaces
• Needle assembly and needle shielding mechanism
• Spring/actuation system and safety interlocks
• Injection trigger, locking features, and dose-confirmation UI
• Outer housing, overmold tooling, and shield materials
• Secondary packaging, instructions-for-use (IFU), and cartons/blisters

A supplier list requires the named parties for each layer in the ZURNAI label or application documentation.

What contract manufacturing organizations (CMOs) produce ZURNAI drug product?

Drug product manufacturing and fill-finish are typically split across specialized CMOs. For autoinjectors, fill-finish often occurs in a facility that can produce a device-compatible sterile drug product (or produce a filled cartridge/syringe that is then assembled into the autoinjector).

For ZURNAI, the drug product and fill-finish manufacturer cannot be identified without the exact FDA label “Manufactured for” and “Manufactured by” lines, plus the application number and site(s).

How do ZURNAI suppliers differ across US, EU, and other markets?

Supplier mapping varies by geography due to:

• Marketing authorization holder vs manufacturing site separation
• Local sterile manufacturing network constraints
• Device certification and distribution partners

A cross-jurisdiction supplier list requires country-specific product dossiers or label/SmPC manufacturer sections. No jurisdictional supplier assignments can be stated for ZURNAI without the specific regulatory dossier identifiers.

Which active ingredient and NDA/API identifies the correct ZURNAI product for sourcing?

Supplier lists are tied to one unique regulated product identity: active ingredient, dosage form, strength, and marketing authorization (NDA/BLA/ANDA) or EU MA number.

ZURNAI (AUTOINJECTOR) alone is insufficient to determine:

• The active ingredient and strength
• The application number(s) and submission types
• The Orange Book listing (if any)
• The listed manufacturer/labeler and each manufacturing site

Without those identifiers, any “suppliers for ZURNAI” would not meet a litigation-ready or regulatory-ready standard.

What Orange Book entries or device listings reveal about ZURNAI suppliers?

Orange Book listings typically show:

• NDA number and listed drug
• Patent/EXCLUSIVITY associations
• Sometimes listing-holder/labeler information that helps narrow manufacturing and licensing arrangements

Autoinjectors also have device-side considerations, but Orange Book is only part of the supply-chain visibility. Without ZURNAI’s NDA and labeler identity, no supplier conclusions can be drawn.

What patent or trade-secret risks can affect ZURNAI autoinjector sourcing?

Supply-chain risk depends on:

• Device mechanism patents (spring/needle shielding/safety lock)
• Combination product IP (device+drug assembly interface)
• Manufacturing method patents (sterile filling, cartridge compatibility)
• Improvements and lifecycle patents

A ZURNAI-specific IP barrier assessment requires the active ingredient identity and corresponding patent family search targets. Those are not available from “ZURNAI (autoinjector)” alone.

Key takeaways

• A complete, authoritative supplier list for ZURNAI (autoinjector) cannot be produced without the product’s unique regulatory identity (active ingredient plus application/label manufacturer identifiers).
• Supplier mapping for autoinjectors must be built from the FDA label and/or regulatory dossier manufacturer fields, which name drug product/fill-finish and device system parties.
• Any supplier list without those identifiers would be non-actionable for procurement, contracting, or litigation.

FAQs

1. How can I identify ZURNAI autoinjector device suppliers using only FDA label text?
2. What manufacturing sites typically support autoinjector fill-finish and cartridge assembly?
3. What documentation best confirms autoinjector subcomponent sourcing (needle, spring, safety lock)?
4. How do device and drug product manufacturing responsibilities differ for combination products?
5. What sources reliably map a branded autoinjector’s manufacturer network across multiple countries?

References

(No sources cited because no ZURNAI regulatory identifiers, label text, Orange Book entry, or FDA application data were provided.)