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Suppliers and packagers for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
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NALOXONE HYDROCHLORIDE (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 |
|---|---|---|---|---|---|---|---|---|---|
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457 | NDA | Kaleo, Inc. | 60842-002-02 | 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK | 2022-02-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Naloxone Hydrochloride (Autoinjector) Suppliers: Contract Manufacturing and Key Upstream Inputs
Who supplies naloxone hydrochloride autoinjectors to the market?
Naloxone hydrochloride autoinjectors are sourced through branded manufacturer supply chains that typically use (1) drug substance and drug product manufacturing/packaging by contract manufacturers, and (2) autoinjector device and electromechanical components from med-device OEMs. Across markets, the branded product supply chain concentrates around a small set of device platforms and CMOs that support both sterile fill-finish and device integration.
Because “naloxone hydrochloride (autoinjector)” is a platform product name that spans multiple branded presentations and device forms (different injectors, spring strengths, needle gauges, and cartridge formats), suppliers are best treated by product family (branded label) and by function (drug manufacturing vs. device assembly vs. packaging).
Branded product supply chains (device + drug product integration)
| Branded autoinjector (example market identifiers) | Device platform family | Typical supplier roles in the chain |
|---|---|---|
| Narcan Nasal (not autoinjector) | N/A | Not included here |
| Naloxone autoinjector brands | Autoinjector OEM families | Drug substance and drug product (sterile fill-finish), device manufacturing, final packaging, distribution |
No complete, universally agreed supplier list exists for “naloxone hydrochloride (autoinjector)” as a single line item, because supplier composition changes by country, labeler, and regulatory filing. For business procurement and R&D planning, supplier mapping must be done label-by-label using regulatory filings and manufacturing site disclosures.
Which companies are the most common contract partners for sterile naloxone drug product?
Autoinjector naloxone requires sterile manufacturing, typically handled by specialized sterile injectables CMOs capable of filling naloxone hydrochloride solution or suspension into a device-compatible container/cartridge, then qualifying for assembly into autoinjectors.
Common CMO functions include:
- Sterile drug product fill-finish (solution filling, stoppering/closing, lyophilization only if applicable to a formulation)
- Container-closure compatibility with the autoinjector cartridge or syringe barrel
- Device integration support under controlled change control (often performed by a device assembly partner or the same integrated manufacturer for final QA release)
What device OEMs and component suppliers support autoinjector systems?
Autoinjectors use a repeatable set of subassemblies. Suppliers in this layer typically provide:
- Injection mechanism (spring drive, striker, plunger, needle actuation)
- Needle assembly (sterile needles, hub-to-barrel compatibility)
- Cartridge and barrier system (fluid path, seals, leakproofing)
- Safety features (needle shield, lockout, accidental actuation prevention)
Market-leading autoinjector OEMs provide complete mechanical platforms and component kits that drug manufacturers can integrate with their drug product. The supplier set is constrained by regulatory precedent and device performance qualification requirements.
How to structure a supplier shortlist for naloxone hydrochloride autoinjectors
For procurement, investment diligence, or R&D vendor selection, build the shortlist by function:
1) Labeler / Marketing Authorization Holder (MAH)
- Owns the regulatory dossier and change control for both drug and device interfaces.
2) Sterile fill-finish CMO
- Produces naloxone hydrochloride drug product under cGMP.
- Supplies drug product to device assembly.
- Provides batch-level documentation (CoA, deviation history, stability commitments).
3) Autoinjector device OEM / device assembly site
- Manufactures autoinjector housings, internal injection mechanism, needle actuation system.
- Performs device assembly with drug cartridge/filled syringe integration.
- Conducts functional testing (actuation, needle deployment, dose delivery) and packages into the final kit.
4) Packaging and logistics
- Produces outer cartons, leaflets, and unit presentation.
- Manages cold-chain only if required by the specific naloxone formulation and storage conditions.
Key diligence checks to confirm the “supplier” you are buying from
When evaluating suppliers for naloxone hydrochloride autoinjectors, require proof for each link in the chain:
- GMP manufacturing site for sterile fill-finish (stated on batch documentation and regulatory submissions)
- Device integration qualification (evidence the filled drug container is compatible with the specific injector platform)
- Needle and cartridge compatibility (extractable/leachable and interface integrity testing)
- Right-to-market and distribution chain (labeler release authority and QA disposition responsibilities)
- Change control history for formulation, container-closure, needle gauge, or injection mechanism
Key Takeaways
- “Naloxone hydrochloride (autoinjector)” is not one fixed supply chain; it maps to multiple branded labelers and device platforms.
- Supplier mapping must be performed by label and presentation, separating sterile fill-finish CMO from autoinjector device OEM/device assembly and from final packaging/distribution.
- A reliable supplier shortlist for procurement or diligence focuses on the MAH, the sterile manufacturing site, and the device assembly site, then validates interface qualification and batch-release governance.
FAQs
1) What does “supplier” mean for naloxone hydrochloride autoinjectors?
It usually spans three layers: sterile fill-finish (drug product), autoinjector device OEM or device assembly, and final packaging/distribution under the labeler’s QA release.
2) Is the sterile fill-finish supplier the same as the autoinjector device supplier?
Often they are different; some integrated suppliers do both, but most programs use specialized sterile injectables CMOs plus device OEMs.
3) What evidence should I require to confirm device-drug interface qualification?
Batch documentation plus qualification/validation evidence that the filled container/cartridge meets the autoinjector platform’s dose delivery and functional test criteria.
4) Why do suppliers vary across countries?
Regulatory dossiers, tendering, and manufacturing capacity allocation differ by market; device platform selection and labeling can change by territory.
5) What is the fastest way to identify real suppliers for a specific naloxone autoinjector?
Use the exact branded presentation (country label) and extract manufacturing site and device assembly information from regulatory submissions and batch release disclosures tied to that specific product.
References
[1] FDA. Autoinjector drug-device combination product information and regulatory frameworks (FDA labeling and submission context). U.S. Food and Drug Administration.
[2] EMA. Guidance and regulatory expectations for combination products and device-drug interfaces. European Medicines Agency.
[3] ISO. ISO 11608 series (Injection systems for medical use). International Organization for Standardization.
[4] USP. Sterile product and container-closure compatibility chapters applicable to injectable drug products. United States Pharmacopeia.
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