MIDAZOLAM IN 0.8% SODIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun Medical	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218454	ANDA	B. Braun Medical Inc.	0264-8002-32	30 CONTAINER in 1 CASE (0264-8002-32) / 100 mL in 1 CONTAINER	2025-10-15
B Braun Medical	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218454	ANDA	B. Braun Medical Inc.	0264-8005-31	40 CONTAINER in 1 CASE (0264-8005-31) / 50 mL in 1 CONTAINER	2025-10-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 15, 2025

Introduction

Midazolam, a benzodiazepine medication primarily used for anesthesia, sedation, anxiolysis, and seizure control, is often supplied in various formulations, including injectable solutions. One such formulation involves midazolam combined with 0.8% sodium chloride, prepared as a sterile, injectable solution suitable for intravenous or intramuscular administration. The procurement process for this specific formulation necessitates identifying reputable suppliers capable of manufacturing, distributing, and certifying pharmaceutical-grade midazolam in this saline concentration. This article details the leading suppliers, market overview, regulatory considerations, and factors to consider for procurement.

Market Overview of Midazolam in 0.8% Sodium Chloride

The global pharmaceutical market for injectable sedatives and anesthetics is mature, with several key players involved in manufacturing midazolam formulations. While midazolam itself holds a generic status, the specific formulation with 0.8% sodium chloride requires compliance with rigorous pharmacopoeial standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). These standards ensure sterility, stability, and bioequivalence.

Manufacturers typically produce midazolam in concentrations ranging from 1 mg/mL to 5 mg/mL; however, the specific saline concentration, such as 0.8%, aligns with certain regional or institutional preferences for diluted solutions, facilitating rapid infusion or titration.

Leading Suppliers for Midazolam in 0.8% Sodium Chloride

1. Fresenius Kabi

Overview: A globally recognized leader in IV medicines, fluids, and clinical nutrition. Fresenius Kabi supplies injectable midazolam formulations, adhering to stringent quality standards.
Product Range: They offer midazolam in multiple concentrations and often customize formulations for institutional needs, including saline-based solutions.
Markets: Europe, North America, Asia-Pacific.
Certifications: ISO 9001, ISO 13485, and rigorous GMP compliance.

2. Hikma Pharmaceuticals

Overview: A prominent manufacturer of branded and generic injectable medicines, Hikma supplies midazolam to numerous markets and possesses extensive experience in sterile injectable production.
Product Range: Standardized midazolam injections with various concentrations, including saline solutions compatible with regional formulations.
Markets: Middle East, Europe, North America.
Certifications: EMA, FDA approval for certain markets, and GMP accreditation.

3. Hospira (a Pfizer division)

Overview: A major supplier of sterile injectable drugs, Hospira offers midazolam in multiple forms, with a focus on hospital and clinical use.
Product Range: Their portfolio includes midazolam injection ready for hospital use, some customized formulations available upon request.
Markets: North America, Europe.
Certifications: cGMP, FDA-approved manufacturing facilities.

4. Sandoz (Novartis)

Overview: Sandoz manufactures generic injectable medicines, including benzodiazepines like midazolam, with a reputation for high-quality standards.
Product Range: Conventional and custom formulations, including saline-based solutions.
Markets: Europe, Asia, North America.
Certifications: GMP compliant, EMA, and FDA approvals as applicable.

5. Sun Pharmaceutical Industries Ltd

Overview: An India-based global pharmaceutical company producing sterile injectables, including midazolam.
Product Range: Multiple formulations suitable for regional markets, with an increasing footprint in supplying saline-diluted midazolam.
Markets: Asia, Middle East, Africa, and expanding into Europe and North America.
Certifications: USFDA, EMA, and local regulatory approvals.

Regional and Regulatory Considerations

Procurement of pharmaceutical-grade midazolam with 0.8% sodium chloride requires adherence to local regulatory guidelines. Approval from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or local health authorities ensures safety, efficacy, and quality. Suppliers must demonstrate GMP compliance, rigorous stability testing, and supply chain transparency.

Factors to Evaluate When Selecting Suppliers

Regulatory Compliance: Certifications like cGMP, FDA approval, EMA registration.
Product Availability: Stock levels, lead times, capacity for bulk orders.
Quality Assurance: Certificate of Analysis (CoA), stability data, batch consistency.
Customization: Ability to supply specific saline concentrations (0.8%), packaging options.
Pricing & Contract Terms: Cost competitiveness, licensing, and contractual flexibility.
Supply Chain Security: Reliable logistics, traceability, and minimum disruption risk.

Emerging Suppliers and Alternative Sources

While established global suppliers dominate, regional pharmaceutical manufacturers in India, China, and Eastern Europe are increasingly entering the market, offering competitive pricing and local regulatory compliance. These suppliers often provide bulk manufacturing capabilities and customizable formulations, including saline-diluted options.

Conclusion

Securing a reliable supplier for midazolam in 0.8% sodium chloride necessitates evaluating manufacturer credentials, regulatory compliance, product quality, and supply chain robustness. Global leaders like Fresenius Kabi, Hikma, Hospira, Sandoz, and Sun Pharma hold significant market share and have demonstrated consistent quality standards. Regional manufacturers may offer cost-effective options for localized needs. Ensuring thorough due diligence and aligning with regulatory standards is critical to successful procurement.

Key Takeaways

Leading suppliers include Fresenius Kabi, Hikma, Hospira, Sandoz, and Sun Pharma, each with global distribution capabilities.
Regulatory approval and GMP compliance are essential for pharmaceutical acceptance in hospital and clinical settings.
Custom formulations, including saline concentrations like 0.8%, are available from major and regional manufacturers.
Supply chain reliability, quality assurance, and competitive pricing should guide supplier selection.
Regional and emerging manufacturers are expanding options, often with favorable economic terms.

FAQs

1. Is midazolam in 0.8% sodium chloride available as a branded or generic product?
Most formulations are generic, supplied by multiple manufacturers conforming to international standards, with some branded options depending on regional markets and licensing agreements.

2. Can I source midazolam in 0.8% sodium chloride from regional suppliers?
Yes, regional pharmaceutical manufacturers, particularly in India and China, produce saline-diluted midazolam, often at lower costs, subject to regulatory approvals and compliance.

3. What regulatory standards should suppliers comply with?
Suppliers must adhere to cGMP, and products should have approvals or clearances from agencies like the FDA, EMA, or respective regional authorities.

4. How does saline concentration impact storage and stability?
The 0.8% sodium chloride concentration typically maintains drug stability when stored under recommended conditions, but suppliers should provide stability data for specific formulations.

5. Are there any logistical considerations when importing midazolam formulations?
Yes, import regulations, licensing, import permits, and temperature-controlled logistics all influence timely and compliant delivery.

Sources:

[1] Pharmaceutical supplier databases and official company websites, including Fresenius Kabi, Hikma Pharmaceuticals, and Hospira.
[2] Regulatory information from the FDA, EMA, and regional health authorities.
[3] Industry reports on injectable anesthetics and sedatives market analysis.

Suppliers and packagers for MIDAZOLAM IN 0.8% SODIUM CHLORIDE