MIDAZOLAM HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154	ANDA	Fresenius Kabi USA, LLC	63323-411-10	10 VIAL in 1 TRAY (63323-411-10) / 10 mL in 1 VIAL (63323-411-13)	2000-07-14
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154	ANDA	Fresenius Kabi USA, LLC	63323-411-12	25 VIAL in 1 TRAY (63323-411-12) / 2 mL in 1 VIAL (63323-411-15)	2000-07-14
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154	ANDA	Fresenius Kabi USA, LLC	63323-411-25	25 VIAL in 1 TRAY (63323-411-25) / 5 mL in 1 VIAL (63323-411-18)	2000-07-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Midazolam hydrochloride is a widely used benzodiazepine primarily employed for anesthesia induction, sedation in intensive care units, and procedural sedation. Its efficacy, rapid onset, and relatively short duration of action have rendered it a critical component in various medical settings. As demand surges globally, the supply chain's robustness becomes paramount for healthcare providers, pharmaceutical companies, and regulators. This article provides a comprehensive overview of the key suppliers for midazolam hydrochloride, emphasizing their manufacturing capabilities, market reach, regulatory compliance, and strategic significance.

Global Manufacturing Landscape

The supply of midazolam hydrochloride hinges on a handful of key pharmaceutical manufacturers primarily located in India, China, Europe, and the United States. These regions host both established pharmaceutical giants and specialized API (Active Pharmaceutical Ingredient) producers capable of synthesizing high-purity midazolam hydrochloride.

Major Suppliers and Manufacturers

1. Sun Pharmaceutical Industries Ltd.

Overview: An Indian multinational, Sun Pharma is among the world's leading producers of generic pharmaceuticals, including midazolam hydrochloride.
Manufacturing Capabilities: Their facilities in India and the United States are compliant with cGMP guidelines, producing midazolam API at pharmaceutical-grade purity.
Market Reach: Sun Pharma exports to over 100 countries, serving both generic drug producers and institutional healthcare providers.
Regulatory Compliance: Holds approvals from US FDA, EMA, and other regulatory authorities, ensuring high-quality standards.

2. Cipla Limited

Overview: Another key Indian manufacturer, Cipla specializes in sterile injectables, including benzodiazepine APIs.
Manufacturing Capabilities: Their API plant in Maharashtra adheres to stringent regulatory standards, with a focus on sterile APIs like midazolam.
Market Reach: Cipla's products are distributed globally with a focus on emerging markets and regulated regions.
Regulatory Compliance: Certified by US FDA, EU-GMP, and other agencies, facilitating access to developed markets.

3. Zhuhai Pharmaceutical Co., Ltd. / Hainan Westland Biological Pharmacy

Overview: Based in China, these manufacturers supply pharmaceutical raw materials, including midazolam hydrochloride.
Manufacturing Capabilities: Specialize in the synthesis of benzodiazepines with cost-competitive processes.
Market Reach: Primarily serve Asian markets, with increasing exports to Africa and Latin America.
Regulatory Compliance: Gaining approvals from WHO PQ and some regional regulators; however, registration in strict markets like the US remains limited.

4. North China Pharmaceutical Group Corporation (NCPC)

Overview: A Chinese state-owned enterprise with scale manufacturing capabilities for midazolam and other anesthetic agents.
Manufacturing Capabilities: Offers bulk API suitable for regulated markets; invests heavily in quality control.
Market Reach: Supplies into domestic Chinese markets and select international markets based on licensing agreements.
Regulatory Compliance: Working towards obtaining US FDA and EMA approvals.

5. Fagron NV

Overview: A European-based supplier specializing in pharmaceutical ingredients and compounding products.
Manufacturing Capabilities: Produces midazolam hydrochloride for compounding pharmacies, especially within Europe.
Market Reach: Strong presence across European healthcare institutions and compounding sectors.
Regulatory Compliance: Compliant with EU-GMP standards, ensuring high-quality ingredients.

6. Teva Pharmaceutical Industries Ltd.

Overview: A global generic pharmaceutical leader based in Israel.
Manufacturing Capabilities: Produces a spectrum of injectable APIs, including benzodiazepines.
Market Reach: Extensive international distribution, with supply agreements in North America, Europe, and Middle East.
Regulatory Compliance: Holds numerous approvals, including US FDA, EMA, and Japanese PMDA.

Emerging and Niche Suppliers

Emerging API producers in Eastern Europe and Latin America are increasingly investing in midazolam manufacturing capabilities due to growing global demand. These suppliers often focus on cost competitiveness and regional distribution.

Regulatory and Quality Considerations

Suppliers for midazolam hydrochloride must adhere to strict regulatory standards due to its use in sensitive medical procedures. High-quality API suppliers typically possess:

GMP Certification: Good Manufacturing Practice compliance from major regulatory bodies.
Quality Assurance: Batch consistency, low impurities, and stability.
Regulatory Approvals: Necessary for excipient and active ingredient registration in target markets.

Failure to meet these standards risks supply disruptions or regulatory rejection, emphasizing the importance of verified, compliant suppliers.

Strategic Supplier Selection

Healthcare institutions and pharmaceutical manufacturers should consider the following when sourcing midazolam hydrochloride:

Regulatory Status: Ensure supplier compliance with WHO, FDA, EMA, or regional standards.
Supply Chain Stability: Evaluate supplier capacity, historical throughput, and risk mitigation strategies.
Quality Certifications: Confirm GMP certification and analytical testing protocols.
Market Footprint: Preference for suppliers with proven global distribution capabilities and regulatory licensing.

Emerging Trends and Future Outlook

The midazolam supply chain is poised for transformation driven by:

Manufacturing Consolidation: Increased mergers to enhance capacity and regulatory compliance.
Enhanced Regulatory Scrutiny: Suppliers expanding compliance efforts to meet evolving standards.
Regional Production Growth: Increased manufacturing capacity in India, China, and Eastern Europe to meet rising demand.
Market Diversification: New suppliers entering niche markets, including compounding and specialty formulations.

Overall, the ongoing optimization of global manufacturing networks, coupled with regulatory stringent standards, will shape the availability and pricing of midazolam hydrochloride in the coming years.

Key Takeaways

Leading global suppliers of midazolam hydrochloride include Sun Pharma, Cipla, Teva, and Chinese manufacturers like Zhuhai Pharmaceutical.
Suppliers with GMP certification and regulatory approvals offer the highest assurance of quality and supply reliability.
Regulatory compliance remains paramount, especially for suppliers targeting developed markets like the US and EU.
Diversifying suppliers and fostering supplier relationships can mitigate risks associated with supply chain disruptions.
Emerging markets are becoming increasingly important in the midazolam hydrocloride supply landscape, offering competitive options for regional procurement.

FAQs

1. What are the primary regions manufacturing midazolam hydrochloride globally?
The primary regions include India, China, Europe, and North America. India and China dominate due to large-scale manufacturing and cost advantages, while Europe and North America focus on high-quality, regulated supplies.

2. How can healthcare providers ensure the quality of midazolam hydrochloride from suppliers?
They should verify GMP certification, review regulatory approvals, conduct batch testing, and establish supply agreements with suppliers demonstrating consistent quality records.

3. Are generic midazolam hydrochloride supplies suitable for all markets?
Generics can be suitable if they meet regulatory standards and are approved by local authorities. However, some markets impose strict requirements that necessitate suppliers to hold specific certifications like FDA or EMA approval.

4. What are the risks associated with sourcing midazolam hydrochloride from emerging markets?
Potential risks include inconsistent quality, regulatory non-compliance, supply stability issues, and limited regulatory approvals. Conducting thorough due diligence mitigates these risks.

5. What trends influence the future supply of midazolam hydrochloride?
Increasing regulatory standards, manufacturing consolidations, regional capacity expansion, and demand growth are key trends shaping the midazolam supply landscape.

References

[1] Market data and regulatory insights derived from industry reports and public manufacturer disclosures.
[2] Information sourced from company websites, regulatory filings, and pharmaceutical industry publications.

(End of article)

Suppliers and packagers for generic pharmaceutical drug: MIDAZOLAM HYDROCHLORIDE