MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR): Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rafa Labs Ltd	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	midazolam hydrochloride	SOLUTION;INTRAMUSCULAR	216359	NDA	Rafa Laboratories, Ltd.	71053-595-01	480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE	2022-08-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 13, 2026

Suppliers for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR): Who Manufactures, Packages, and Supplies the US Market

Midazolam hydrochloride autoinjectors are supplied through a limited set of vertically integrated and contract manufacturing networks, with supply tied to (1) the filled injection-device manufacturing and (2) the sterile drug-product filling and packaging line. For the US market, the supplier map for an “autoinjector” presentation is constrained by FDA device-drug combination manufacturing controls, sterility assurance, and device subcomponents (cartridge/needle, injector housing, spring-driven actuation). The practical supplier set therefore splits into device-platform suppliers and drug-product/combination product contract manufacturers.

This analysis is restricted to supplier entities that can be verified for an autoinjector presentation of midazolam hydrochloride and mapped to combination-product manufacturing responsibility. If a supplier cannot be tied to a specific autoinjector product configuration, it is excluded.

Which companies supply midazolam hydrochloride autoinjector devices and drug-product combination products?

A verified supplier set for an autoinjector presentation must cover two layers:

Device platform and functional components
Needle assembly, cartridge, spring/actuation mechanism, plunger/stop elements, molded housing, and packaging.
Sterile drug-product operations for a combination product
Midazolam hydrochloride drug substance-to-drug product conversion, sterile filling, sealing, labeling, and configuration into the finished autoinjector.

Featured point: For autoinjectors, the finished product supplier typically contracts device assembly and sterile drug filling through combination-product qualified facilities, with final configuration and labeling under the marketing authorization holder’s controls.

How do device-platform suppliers participate in midazolam autoinjectors?

Autoinjector device suppliers typically provide:

Actuation module (spring plunger, trigger mechanism)
Cartridge or prefilled syringe body integration compatible with sterilization and assembly
Needle and needle guard subassemblies (sterility and particulate control)
Molding and machining for housing components

In combination-product workflows, device-platform suppliers often operate as upstream partners rather than the labeled finished-product manufacturer, while the contract manufacturer performs sterile filling and final assembled unit release.

How do sterile fill-finish manufacturers participate in midazolam autoinjectors?

Sterile fill-finish participation usually includes:

Aseptic filling under ISO-class cleanroom conditions
Container closure integrity and leak testing
Sterility assurance and environmental monitoring
Final packaging into device-specific kits or preassembled autoinjector components

For midazolam autoinjector presentations, the fill-finish site must support the exact container-closure system used in the autoinjector assembly, plus device-specific assembly compatibility.

What upstream manufacturers supply the drug substance and sterile fill-finish for midazolam hydrochloride autoinjectors?

Midazolam hydrochloride is a controlled benzodiazepine active ingredient with a supply chain that typically involves:

Licensed chemical synthesis manufacturers for API
GMP API packaging and incoming-material QC testing
Drug-product formulation and aseptic fill-finish contract manufacturers

For autoinjectors, the drug-product supplier is chosen partly on device compatibility and partly on aseptic capability and combination-product QA systems.

Business consequence: API shortages can cause autoinjector supply pauses even when device assembly capacity exists, because sterile filling schedules depend on API release and formulation readiness.

What contract manufacturing organizations (CMOs) are used for autoinjector sterile filling and final assembly?

For an autoinjector drug-device combination product, CMOs that matter for supplier planning are those that can:

Perform sterile fill-finish for the midazolam drug product
Integrate with an autoinjector platform (pre-assembled device integration or final assembly)
Support combination-product regulatory expectations (device and drug GMP alignment)
Provide stability data for the finished combination configuration

Procurement implication: If a CMO can only do sterile filling but not device integration (or vice versa), the finished autoinjector supply depends on a second specialized partner, increasing lead time and batch coordination risk.

Which suppliers control needle assemblies, cartridges, and actuation mechanisms for midazolam autoinjectors?

The autoinjector sub-supply chain is usually the critical path for lead time because:

Needle assemblies must meet particulate and sterility requirements
Actuation mechanisms require tight tolerances and validated assembly processes
Cartridge compatibility governs usable fill volume and dose accuracy

Procurement planning therefore typically treats needle assembly and actuation components as separate supplier categories with distinct qualification packages and lead-time buffers.

What patents and Orange Book listings affect supplier access for midazolam hydrochloride autoinjector products?

If the midazolam autoinjector is marketed as a drug-device combination with an FDA-approved NDA and listed in FDA’s Orange Book, patent protection would bind generic and licensing entry for:

Formulation (midazolam concentration, excipients, pH, stabilizers)
Container closure system
Manufacturing process and controls
Device subcomponents where integrated with the drug product

Limitation: Supplier eligibility is not determined by patents alone. FDA approvals for the drug-device combination and validated manufacturing process qualification govern who can supply at commercial scale.

When do generic or “follow-on” autoinjector midazolam products become viable from a supplier standpoint?

Supplier timing for generic/follow-on entry depends on:

Patent expiry for listed Orange Book patents
Exclusivity periods (if any)
Whether the generic can replicate the device-drug interface, dose accuracy, and usability under the autoinjector platform

If exclusivity/patent protection prevents approval, CMOs may still manufacture components but cannot assemble and commercialize the finished autoinjector without regulatory clearance.

What competitive landscape exists for midazolam hydrochloride autoinjectors in the US?

The market for rescue benzodiazepine injectables has tight device constraints. A supplier map for autoinjectors typically concentrates around:

One or two autoinjector drug-device platforms
A small set of qualified sterile fill-finish and combination assembly CMOs
Upstream needle and actuation suppliers supporting multiple drug programs

Commercial implication: Even when multiple CMOs have sterile filling capability, only those qualified for the specific autoinjector integration win supply contracts.

Key Takeaways

Midazolam hydrochloride autoinjector supply chains split into device-platform (actuation, cartridge, needle assembly) and sterile drug-product/combination assembly (aseptic filling, device integration, packaging).
Supplier lists for autoinjectors must be tied to combination-product manufacturing responsibility; sterile-only suppliers and device-only suppliers do not cover the finished product demand.
Lead-time risk is driven by sterile filling release dates and autoinjector subcomponent availability (needle assemblies, actuation modules, cartridge components).

FAQs

1) Who is the primary manufacturer of MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) in the US?

The primary manufacturer is the FDA marketing authorization holder’s finished-product manufacturer for the specific labeled autoinjector configuration.

2) Do autoinjector suppliers provide sterile fill-finish for midazolam or just device hardware?

Autoinjector device suppliers typically provide hardware and subassemblies; sterile fill-finish is usually performed by combination-product qualified CMOs.

3) What parts of the autoinjector are most likely to constrain supply?

Needle assemblies, cartridge integration-compatible components, and actuation modules are the most frequent constraints due to qualification and lead-time variability.

4) Can API suppliers impact autoinjector delivery even when device capacity exists?

Yes. Aseptic sterile filling is dependent on API release and formulation readiness, so API shortages can halt autoinjector production.

5) What determines whether a new supplier can commercialize an autoinjector midazolam product?

Regulatory approval for the specific drug-device combination, plus validated manufacturing that reproduces the autoinjector configuration and drug-device interface.

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-13).
FDA. Drug Products, Including Biological Products, for Which Certain Patents Have Been Identified. (Orange Book guidance and listings). (Accessed 2026-06-13).

Suppliers and packagers for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)