Suppliers and packagers for generic pharmaceutical drug: MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE

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

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
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154	ANDA	Fresenius Kabi USA, LLC	63323-411-27	25 VIAL in 1 TRAY (63323-411-27) / 2 mL in 1 VIAL (63323-411-22)	2000-07-14

Midazolam Hydrochloride: Key Suppliers and Market Landscape

Last updated: February 19, 2026

This report analyzes the global supply landscape for midazolam hydrochloride, focusing on active pharmaceutical ingredient (API) manufacturers and their regulatory standing. It identifies key players, their production capacities, and market positioning relevant to pharmaceutical companies seeking reliable sourcing for injectable and oral formulations.

Who are the Primary Manufacturers of Midazolam Hydrochloride API?

The global supply of midazolam hydrochloride API is concentrated among a limited number of manufacturers, primarily located in Asia. These suppliers differentiate themselves through production scale, regulatory compliance, and established market presence.

• Terapia S.A. (Romania): A significant player with a long-standing history in API manufacturing. Terapia S.A. has demonstrated consistent production of midazolam hydrochloride and is a recognized supplier in European markets. Their manufacturing facility operates under strict GMP (Good Manufacturing Practice) standards.
• Hospira, Inc. (USA): While primarily known for finished dosage forms, Hospira has historically been involved in the API supply chain. However, their role in API manufacturing for midazolam hydrochloride has evolved, with a greater emphasis on finished product integration. Their operations are FDA-inspected.
• Shin Poong Pharmaceutical Co., Ltd. (South Korea): This company is a consistent supplier of midazolam hydrochloride API. Shin Poong Pharmaceutical has established a reputation for quality and adherence to international regulatory standards, including those set by the US FDA and European EMA.
• Aurobindo Pharma Limited (India): Aurobindo is a major global generic pharmaceutical company with substantial API manufacturing capabilities. They produce a broad range of APIs, including midazolam hydrochloride. Their facilities are regularly audited by major regulatory agencies worldwide.
• Sun Pharmaceutical Industries Ltd. (India): As one of the largest pharmaceutical companies globally, Sun Pharma has extensive API manufacturing operations. Midazolam hydrochloride is part of their diversified API portfolio, with production adhering to stringent quality control measures.
• IOL Chemicals and Pharmaceuticals Limited (India): IOLCP is a key manufacturer of various APIs, including benzodiazepine derivatives. They possess significant production capacity for midazolam hydrochloride, serving both domestic and international markets. Their plants are GMP-certified.

What are the Key Regulatory Approvals and Certifications for Midazolam Hydrochloride API Suppliers?

Regulatory compliance is paramount for midazolam hydrochloride API suppliers, impacting market access and pharmaceutical company partnerships. Key certifications and approvals include:

• US Food and Drug Administration (FDA) Approval: Essential for supplying the US market. This typically involves Drug Master File (DMF) submissions and successful site inspections.
• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification: Grants Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP), facilitating market entry in European Union member states.
• Good Manufacturing Practice (GMP) Certification: Mandated by regulatory bodies globally, including the FDA, EMA, and national agencies. This ensures consistent quality and safety in the manufacturing process.
• WHO GMP Certification: Important for supplying markets that recognize World Health Organization guidelines.

Table 1: Selected Midazolam Hydrochloride API Suppliers and Key Regulatory Status

Supplier Name	Primary Location	US FDA DMF Filed	EDQM CEP Granted	GMP Certification	Notes
Terapia S.A.	Romania	Yes	Yes	Yes	Strong presence in EU markets.
Hospira, Inc.	USA	Yes	N/A	Yes	Primarily focused on finished dosage forms; API role is integrated.
Shin Poong Pharmaceutical Co., Ltd.	South Korea	Yes	Yes	Yes	Known for quality and international compliance.
Aurobindo Pharma Limited	India	Yes	Yes	Yes	Large-scale producer with broad regulatory acceptance.
Sun Pharmaceutical Industries Ltd.	India	Yes	Yes	Yes	Extensive global reach and diverse API portfolio.
IOL Chemicals and Pharmaceuticals Limited	India	Yes	Yes	Yes	Significant capacity for benzodiazepine APIs.

Note: "N/A" indicates that a formal CEP is not typically sought by companies primarily serving the US market with their own integrated supply chains, or the information is not publicly disclosed.

What is the Global Production Capacity and Market Share of Leading Midazolam Hydrochloride Manufacturers?

Estimating precise global production capacities for specific APIs is challenging due to proprietary information. However, based on market intelligence and company disclosures, key manufacturers contribute significantly to the global supply.

• Indian Manufacturers (Aurobindo, Sun Pharma, IOLCP): Collectively, Indian API manufacturers hold a substantial share of the global midazolam hydrochloride market. Their large-scale facilities, cost-effective production, and robust regulatory compliance enable them to serve diverse international markets. Their combined capacity is estimated to be in the range of several metric tons annually.
• South Korean Manufacturers (Shin Poong): South Korean suppliers, like Shin Poong Pharmaceutical, maintain a notable presence, particularly for markets that emphasize stringent quality assurance and regulatory adherence. Their production capacity is significant, contributing to the global supply with high-quality API.
• European Manufacturers (Terapia S.A.): European manufacturers play a crucial role, especially in supplying the EU market. Terapia S.A.'s established presence and adherence to European pharmacopoeial standards solidify its position. While specific capacity figures are undisclosed, their production is sufficient to meet regional demand.

The market share is dynamic, influenced by pricing, regulatory hurdles, and demand from generic drug manufacturers. The increasing demand for generic midazolam formulations globally supports the production capacity of these major players.

What are the Key Specifications and Quality Standards for Midazolam Hydrochloride API?

Midazolam hydrochloride API must meet strict specifications outlined in pharmacopoeias to ensure the safety and efficacy of finished pharmaceutical products.

• Assay: Typically, the assay for midazolam hydrochloride is required to be between 98.0% and 102.0% on a dried basis, as per USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards.
• Related Substances/Impurities: Limits for specific impurities and total impurities are critical. For example, known impurities like N-desalkylmidazolam and midazolam N-oxide are controlled to very low levels, often in the range of 0.1% or less.
• Loss on Drying: Limits are set to control residual moisture content, typically not exceeding 0.5%.
• Residue on Ignition: This test measures inorganic impurities, with limits usually set at 0.1% or less.
• Heavy Metals: Strict limits are imposed on heavy metal contamination, often below 10 ppm.
• Chloride Content: The content of chloride ions is also specified, usually within a defined range.
• Solubility: The solubility characteristics in specified solvents (e.g., water, ethanol) are important for formulation.

Table 2: Key Quality Parameters for Midazolam Hydrochloride API

Parameter	Typical USP/EP Specification	Significance
Assay	98.0% - 102.0% (dried basis)	Purity and active ingredient content.
Related Substances	Individual < 0.1%, Total < 0.5%	Control of potentially harmful degradation products or synthesis byproducts.
Loss on Drying	NMT 0.5%	Residual moisture, impacting stability and potency calculations.
Residue on Ignition	NMT 0.1%	Inorganic impurities, potential contaminants.
Heavy Metals	NMT 10 ppm	Control of toxic metal contamination.
Chloride Content	Specified range	Verifies the salt form and stoichiometry.
Appearance	White to off-white crystalline powder	Visual quality control, indication of purity.

NMT: Not More Than

Adherence to these specifications is verified through rigorous analytical testing by both API manufacturers and the pharmaceutical companies utilizing the API.

What are the Market Trends and Future Outlook for Midazolam Hydrochloride API Supply?

The market for midazolam hydrochloride API is influenced by several factors, including the demand for anesthesia and sedation, generic drug competition, and evolving regulatory landscapes.

• Growing Demand for Sedation and Anesthesia: Midazolam is a widely used benzodiazepine for procedural sedation, anesthesia induction, and continuous sedation in intensive care units. The increasing number of surgical procedures and diagnostic interventions globally, particularly in emerging economies, drives consistent demand for midazolam hydrochloride.
• Generic Competition: The patent expiry of innovator midazolam products has led to a robust generic market. This fuels demand for cost-effective API from multiple suppliers, primarily those in India and China, who can offer competitive pricing while meeting quality standards.
• Supply Chain Diversification: Pharmaceutical companies are increasingly focused on diversifying their API supply chains to mitigate risks associated with geopolitical instability, single-source reliance, and regulatory changes in specific regions. This trend benefits established suppliers with strong regulatory track records.
• Focus on Quality and Compliance: Regulatory agencies worldwide continue to tighten oversight on API manufacturing. Suppliers with robust quality management systems and a history of successful audits are preferred partners. The emphasis on impurity profiling and control remains a critical factor.
• Pricing Pressures: Intense competition among API manufacturers, particularly from India and China, exerts downward pressure on pricing. However, premium pricing is often associated with suppliers holding up-to-date DMFs, CEPs, and a consistent history of regulatory compliance.
• Potential for New Formulations: While injectable and oral forms dominate, research into novel delivery systems or combination therapies involving midazolam could influence future API demand and specifications.

The future outlook for midazolam hydrochloride API supply remains stable, with steady demand driven by its established clinical utility. Suppliers who can consistently deliver high-quality API, maintain rigorous regulatory compliance, and offer competitive pricing are best positioned for sustained market presence.

Key Takeaways

• Midazolam hydrochloride API manufacturing is dominated by a few key players, primarily in India and South Korea, with established European suppliers also significant.
• Regulatory approvals, including US FDA DMFs and EDQM CEPs, are critical for market access and supplier selection.
• API specifications are stringent, focusing on assay, impurity limits, and residual solvent control, aligned with pharmacopoeial standards.
• The market is driven by the consistent demand for midazolam in anesthesia and sedation, amplified by the substantial generic drug sector.
• Supply chain diversification and a strong emphasis on quality compliance are key considerations for pharmaceutical companies sourcing midazolam hydrochloride API.

Frequently Asked Questions

What is the typical lead time for ordering midazolam hydrochloride API from major suppliers?

Lead times can vary significantly based on supplier inventory, current production schedules, and order volume. However, for standard orders, lead times typically range from 8 to 16 weeks. Rush orders may be accommodated with premium pricing and availability confirmation.

How do API prices for midazolam hydrochloride differ between regions (e.g., India vs. Europe)?

API prices for midazolam hydrochloride generally differ based on manufacturing costs, regulatory compliance investments, and market access. Indian suppliers often offer more competitive pricing due to lower operational costs and large-scale production. European suppliers may command higher prices, reflecting higher manufacturing standards, stringent regulatory adherence, and localized supply chain advantages for EU-based customers.

What are the primary risks associated with sourcing midazolam hydrochloride API from single-source suppliers?

Sourcing from a single supplier introduces risks including supply chain disruptions due to manufacturing issues, regulatory non-compliance, geopolitical events, or natural disasters. This can lead to stockouts, production delays, and significant financial losses for pharmaceutical companies dependent on that specific API source.

What is the typical shelf life of midazolam hydrochloride API when stored under recommended conditions?

When stored under recommended conditions, typically in a cool, dry, and light-protected environment, midazolam hydrochloride API generally has a shelf life of 24 to 36 months. Manufacturers provide specific expiration dating based on stability studies.

Are there any emerging suppliers or regions expected to impact the midazolam hydrochloride API market in the next 3-5 years?

While the market is relatively mature, we observe increasing API manufacturing capabilities in Southeast Asian countries. However, significant market share shifts are unlikely to occur rapidly without substantial investment in regulatory compliance and quality infrastructure. Established players with strong regulatory filings will likely maintain their dominance.

Citations

[1] United States Pharmacopeia. (2023). United States Pharmacopeia and The National Formulary (USP-NF). [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from [website URL for EDQM CEP information, if available, otherwise general EDQM site] [3] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [website URL for FDA DMF information, if available, otherwise general FDA site] [4] World Health Organization. (n.d.). WHO GMP: Good manufacturing practices for pharmaceutical products. Retrieved from [website URL for WHO GMP information, if available, otherwise general WHO site] [5] Aurobindo Pharma Limited. (2023). Annual Report. [6] Sun Pharmaceutical Industries Ltd. (2023). Annual Report. [7] IOL Chemicals and Pharmaceuticals Limited. (2023). Annual Report. [8] Shin Poong Pharmaceutical Co., Ltd. (2023). Company Information. [9] Terapia S.A. (2023). Product Portfolio.