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

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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: August 8, 2025

Introduction

Midazolam Hydrochloride in autoinjector format represents a critical product in emergency medicine, used for rapid sedation, anesthesia induction, and status epilepticus management. Its ease of administration via autoinjector enhances rapid response capabilities, especially in pre-hospital or emergency settings. As demand for this medication grows, understanding key suppliers and manufacturing sources becomes vital for healthcare providers, distributors, and stakeholders involved in procurement and strategic sourcing.

Overview of Midazolam Hydrochloride Autoinjector

Midazolam, a short-acting benzodiazepine, is available in various formulations, including injectables for intravenous, intramuscular, and intranasal routes. The autoinjector form is a specialized delivery device designed for swift, simplified administration by trained personnel or even by patients or caregivers in certain contexts. This formulation combines the pharmacological efficacy of midazolam with the convenience and safety of auto-injection technology, ensuring minimal dosage errors and rapid onset.

Key Global Suppliers and Manufacturers

1. Hikma Pharmaceuticals

Overview: Hikma Pharmaceuticals, based in Jordan, is a leading manufacturer of generic injectable medicines, including midazolam. Its global footprint spans the Middle East, Europe, and North America.

Midazolam Autoinjector Status: Hikma supplies midazolam in injectable form, with some formulations available in pre-filled syringes and ampoules. While specific autoinjector versions are not universally available, Hikma's comprehensive portfolio positions it to develop or produce autoinjector variants upon market demand.

Market Presence: Hikma’s sizable manufacturing facilities in Jordan and the UK produce high-volume, high-quality generics recognized by regulatory agencies such as the FDA and EMA.

2. Pfizer Inc.

Overview: Pfizer is a major global pharmaceutical leader with extensive expertise in injectable sedatives and anesthetics, including midazolam.

Midazolam Autoinjector Offerings: Pfizer historically supplies midazolam products, mainly for hospital settings. They have developed specialized delivery systems, and recent trends indicate ongoing interest in autoinjector formats, particularly for outpatient or emergency use.

Regulatory Footprint: Pfizer's products undergo stringent approval processes in multiple markets, with some formulations approved in the US and Europe, although specific autoinjector versions may still be under development or clinical evaluation.

3. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion therapies, with an extensive range of injectable medicines, including midazolam.

Product Availability: It manufactures midazolam in various formulations, including ready-to-use injections suitable for emergency settings. While the company primarily produces traditional formulations, it is actively investing in innovative delivery systems akin to autoinjectors.

Market Strategy: Focused on hospital and pre-hospital markets, Fresenius continues to expand its portfolio for critical care and emergency medicine, possibly including autoinjector prototypes in the future.

4. Teva Pharmaceutical Industries

Overview: Teva is a significant global manufacturer of generic medicines, including benzodiazepines.

Midazolam Supply: Teva produces midazolam in multiple forms, with widespread distribution in North America and Europe. While currently focusing on traditional multidose preparations, their R&D efforts potentially target autoinjector formats given market trends.

5. Local and Regional Manufacturers

Numerous regional manufacturers supply midazolam in various formats, often tailored to local regulatory standards. Notable among these are companies based in India, China, and Eastern Europe, which may either produce generic versions or collaborate with device manufacturers for autoinjector formulations.

Emerging and Specialized Autoinjector Providers

While most traditional pharmaceutical companies supply midazolam in standard injectable formats, the autoinjector variant is a niche category primarily driven by device manufacturers and biotech firms specializing in drug delivery systems. This includes collaborations with medical device companies such as:

BD (Becton Dickinson): Offers injection devices and autoinjector platforms that can be customized for drugs like midazolam.
Ypsomed: A Swiss company providing autoinjector devices with customizable drug cartridges, potentially partnering with pharmaceutical companies to develop midazolam autoinjectors.
Eli Lilly’s PreFilled Syringes: Known for autoinjectors in other therapeutic areas, they could adapt their platforms for emergency midazolam delivery.

Regulatory and Patent Considerations

Developing an autoinjector formulation for midazolam entails navigating complex regulatory frameworks, including FDA approvals and EMA clearances. Patents associated with drug-device combinations and delivery systems may also influence market entry and supplier selection. Proprietary autoinjector platforms from device companies often involve licensing or collaborations with pharmaceutical manufacturers.

Strategic Sourcing and Procurement Insights

Existing Supply Chain: Major pharmaceutical companies such as Hikma, Pfizer, and Fresenius supply standard midazolam injections, which can serve as foundational products for conversion into autoinjector formats either through partnerships or licensing.
Innovation Potential: Firms actively investing in drug delivery device innovations—such as BD and Ypsomed—are positioned to supply autoinjector-based midazolam once regulatory approvals are secured.
Regional Considerations: Regional manufacturers may offer cost-effective alternatives but may vary in device quality and regulatory compliance. Careful evaluation of GMP standards and approval status is essential.
Collaborative Development: The intersection of pharmaceutical expertise and device engineering is anticipated to catalyze the advent of commercialized midazolam autoinjectors. Procurement strategies should consider partnerships with device incumbents to mitigate development timelines.

Conclusion and Outlook

The market for midazolam hydrochloride autoinjectors remains emergent, with the key pharmaceutical suppliers traditionally producing injectable forms rather than autoinjector-specific products. The ongoing integration of drug delivery devices and pharmaceuticals signals potential growth, driven by technological innovation and regulatory approvals. Major pharmaceutical companies such as Hikma, Pfizer, Fresenius Kabi, and Teva serve as foundational suppliers for the active pharmaceutical ingredient (API) and traditional injectable formulations, which could be adapted into autoinjector formats via partnerships with medical device firms.

As market demand escalates—especially amid global health initiatives emphasizing rapid emergency response—the development and procurement of proven, regulatory-compliant midazolam autoinjectors are expected to accelerate. Stakeholders should monitor collaborative ventures, technological advancements, and regulatory pathways to secure reliable sourcing channels for this critical medical device.

Key Takeaways

Leading suppliers of midazolam hydrochloride primarily provide injectable formulations, with key players including Hikma, Pfizer, Fresenius Kabi, and Teva.
Autoinjector-specific formulations are currently limited but are anticipated to emerge through collaborations between pharmaceutical companies and specialized device manufacturers.
Strategic partnerships with device innovators like BD and Ypsomed offer pathways to develop and secure autoinjector supplies rapidly.
Regulatory navigation is essential, as approval for drug-device combinations involves rigorous testing and compliance with regional standards.
Market trends favor innovation and integration of drug and device manufacturing, presenting opportunities for early entrants and strategic procurement.

FAQs

1. Are there any approved midazolam autoinjectors on the market?
No widely recognized, fully approved midazolam autoinjectors are currently available commercially. Most formulations are traditional injectables. However, ongoing development and regulatory submissions may lead to market approvals in future years.

2. Which companies are most likely to supply midazolam autoinjectors in the near term?
Companies specializing in drug-device combination products, such as BD and Ypsomed, are leading candidates, especially through collaborations with pharmaceutical firms capable of providing the active ingredient.

3. How can healthcare providers source midazolam for emergency use?
Currently, most procure standard injectable midazolam from major pharmaceutical manufacturers like Hikma or Fresenius. Adoption of autoinjector formats will depend on regulatory approvals and commercial availability.

4. What regulatory challenges exist for autoinjector development?
The primary challenges involve obtaining approval for the combination of the drug and device, ensuring safety, efficacy, and compliance with medical device and pharmaceutical standards across jurisdictions.

5. Is regional manufacturing a viable option for sourcing midazolam autoinjectors?
Regional manufacturers may offer cost advantages but must demonstrate compliance with GMP standards and obtain necessary regulatory clearances. Such options require careful validation and quality assurance.

References

[1] FDA Drug Database: Midazolam formulations and device approvals.
[2] EMA Regulatory Documents on benzodiazepine inhalers and injectables.
[3] Hikma Pharmaceuticals product portfolio overview.
[4] Pfizer’s Emergency Medicine Device Development Initiatives.
[5] Market analysis reports on drug-device combination products.

Suppliers and packagers for MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)