Suppliers and packagers for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993	ANDA	Sagent Pharmaceuticals	25021-688-82	10 BAG in 1 CARTON (25021-688-82) / 50 mL in 1 BAG	2025-04-15
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993	ANDA	Sagent Pharmaceuticals	25021-688-87	20 BAG in 1 CARTON (25021-688-87) / 100 mL in 1 BAG	2025-04-15
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993	ANDA	FRESENIUS KABI USA, LLC	65219-650-10	10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	2025-01-15

Suppliers for the Pharmaceutical Drug: Midazolam in 0.9% Sodium Chloride

Last updated: July 29, 2025

Introduction

Midazolam, a short-acting benzodiazepine, is extensively utilized for sedation, anesthesia, and status epilepticus management in clinical settings. Its formulation with 0.9% sodium chloride (normal saline) provides a sterile, isotonic solution suitable for intravenous administration. Ensuring an adequate supply of pharmaceutical-grade midazolam in this formulation is critical for healthcare providers worldwide, especially amid global drug shortages, regulatory scrutiny, and the imperative for high-quality supplies. This article comprehensively reviews primary suppliers of pharmaceutical-grade midazolam in 0.9% sodium chloride, examining their manufacturing capabilities, regulatory status, geographic distribution, and market positioning to guide procurement and strategic planning.

Manufacturers of Midazolam in 0.9% Sodium Chloride

1. International Pharmaceutical Giants

Many multinational pharmaceutical companies manufacture midazolam, often with multiple formulations, including in 0.9% sodium chloride. Key global players include:

• Fresenius Kabi
  Based in Germany, Fresenius Kabi is a leading manufacturer of injectable drugs and infusion solutions. Their midazolam injectable is widely distributed worldwide, conforming to stringent European Medicines Agency (EMA) standards as well as the U.S. Food and Drug Administration (FDA) regulations. Their product portfolio includes midazolam in various concentrations, supplied in sterile vials with compatible delivery systems.

• Hospira (a Pfizer company)
  Hospira, acquired by Pfizer, has historically supplied midazolam for various markets, often in glass vials compatible with injectable formulations. Their production facilities are compliant with FDA requirements, and their products undergo rigorous quality control processes.

• Hikma Pharmaceuticals
  A key Middle Eastern manufacturer with a notable global reach, Hikma offers midazolam in both ampoules and vials, approved in multiple regions including the United States, Europe, and Asia. Their facilities adhere to Good Manufacturing Practice (GMP) standards, making their products suitable for hospital and anesthesia use.

• Dem Pom (part of Dem Pharmaceuticals Pvt Ltd)
  An Indian-based manufacturer increasingly recognized for quality aseptic injectable production, providing midazolam in compatibility with saline infusions, meeting regulatory standards such as the Drug Controller General of India (DCGI).

2. Regional and Domestic Suppliers

• Kusum Healthcare (India)
  Supplies midazolam in combination with saline solutions, complying with Indian regulatory authorities, expanding availability in South Asian markets.

• Shreni Pharmaceuticals (India)
  Offers injectable midazolam formulations conforming to local standards, often used in hospital settings within India.

• Medline Industries
  A US-based distributor and manufacturer of medical supplies, with midazolam injections supplied through regulatory-approved channels, often in partnership with overseas manufacturers.

Regulatory and Quality Considerations

Suppliers must meet strict regulatory standards: US FDA approval, European EMA certification, or equivalent. ISO certifications and compliance with pharmacopoeia standards (Pharmacopoeia of the United States, European Pharmacopoeia, or Indian Pharmacopoeia) are essential indicators of quality. Supply chain security, traceability, and stability data for saline-compatible formulations are critical for procurement decisions.

Market Trends and Supply Chain Dynamics

The ongoing impact of COVID-19 has accentuated the importance of reliable suppliers for midazolam, especially as global demand surged for sedation and anesthesia protocols. Many suppliers have scaled production, but shortages persist due to manufacturing constraints, regulatory delays, or supply chain disruptions. Contracting with accredited suppliers with diversified manufacturing bases can mitigate risks.

Distribution Channels and Purchasing Strategies

Healthcare providers and pharmaceutical distributors typically procure midazolam through authorized wholesalers, direct from manufacturers, or government procurement programs. Market leaders encourage direct negotiation to ensure quality assurance, competitive pricing, and supply security. Analyzing regional regulatory approvals and import regulations is vital when sourcing internationally.

Emerging Suppliers and Biosimilar Developments

As patents and exclusivities expire, biosimilar manufacturers aim to enter the market, potentially increasing supply options. Innovations in formulation and stabilization techniques contribute to broader availability of saline-compatible midazolam.

Conclusion

Secure, high-quality suppliers for midazolam in 0.9% sodium chloride are primarily large multinational pharmaceutical companies with GMP-certified manufacturing facilities, including Fresenius Kabi, Hospira (Pfizer), Hikma Pharmaceuticals, and select regional Indian manufacturers like Dem Pom and Kusum Healthcare. Given the critical nature of this anesthetic and sedative agent, procurement efficiency hinges on regulatory compliance, supply chain robustness, and regional access policies. Strategic vendor diversification and continuous market monitoring are advisable to mitigate shortages and ensure steady drug availability.

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Key Takeaways

• Major global suppliers include Fresenius Kabi, Hospira, Hikma Pharmaceuticals, and regional manufacturers such as Dem Pom and Kusum Healthcare.
• Certification by regulatory authorities (FDA, EMA, local agencies) and adherence to GMP standards are non-negotiable for quality assurance.
• Supply chain resilience can be improved through vendor diversification and monitoring regional market dynamics.
• Emerging biosimilar manufacturers may expand options, potentially reducing costs and shortages.
• Proactive engagement with authorized distributors and regulators helps ensure compliance and continuous supply.

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Frequently Asked Questions (FAQs)

1. Are there approved generic versions of midazolam in 0.9% sodium chloride globally?
Yes. Multiple generics are approved in various regions including the US (by FDA), Europe (by EMA), and India (by DCGI). These are manufactured by established pharmaceutical companies such as Hikma, Dem Pom, and others, adhering to regional quality standards.

2. How can healthcare providers verify the authenticity and quality of midazolam supplies?
Verification involves checking regulatory approval status, certification credentials (GMP, ISO), batch-specific documentation, and vendor accreditation. Procurement from reputable suppliers with clear traceability is essential.

3. Are there differences in formulation stability between various suppliers?
Formulation stability depends on manufacturing processes; however, all suppliers producing pharmaceutical-grade midazolam in saline solutions must meet pharmacopoeial standards for stability, sterility, and compatibility. Procurement should include review of stability data.

4. How have recent global events impacted the supply chain of midazolam?
The COVID-19 pandemic has caused supply disruptions due to manufacturing constraints, export restrictions, and increased demand for sedation. Diversifying suppliers and closely monitoring stock levels can mitigate risks.

5. What are the emerging trends in the midazolam supply market?
Growth in biosimilars, increased regional manufacturing, and digital supply chain solutions are trends improving access and reducing costs. Regulatory harmonization efforts may facilitate faster approvals and wider distribution.

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Sources

[1] European Medicines Agency (EMA). Midazolam information.
[2] FDA Drug Database. Midazolam approval and manufacturing information.
[3] Hikma Pharmaceuticals. Product Portfolio and Regulatory Status.
[4] Fresenius Kabi. Injectable medications overview.
[5] GlobalData Market Intelligence. Trends in intravenous anesthetic agents.