Suppliers and packagers for lorazepam

lorazepam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	091383	ANDA	Amneal Pharmaceuticals LLC	65162-687-84	30 mL in 1 BOTTLE, DROPPER (65162-687-84)	2010-02-01
Chartwell Molecular	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	079244	ANDA	Chartwell RX, LLC	62135-549-43	30 mL in 1 BOTTLE (62135-549-43)	2009-04-28
Pharm Assoc	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	090260	ANDA	Pharmaceutical Associates, Inc.	0121-0770-01	1 BOTTLE, DROPPER in 1 CARTON (0121-0770-01) / 30 mL in 1 BOTTLE, DROPPER	2010-11-01
Fresenius Kabi Usa	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	217598	ANDA	Fresenius Kabi USA, LLC	65219-368-24	25 VIAL in 1 TRAY (65219-368-24) / 1 mL in 1 VIAL (65219-368-14)	2024-12-13
Fresenius Kabi Usa	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	217598	ANDA	Fresenius Kabi USA, LLC	65219-368-02	25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01)	2024-12-13
Hospira	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074243	ANDA	Hospira, Inc.	0409-1985-30	10 CARTRIDGE in 1 CARTON (0409-1985-30) / 1 mL in 1 CARTRIDGE (0409-1985-03)	2005-06-06

Lorazepam Drug Substance Suppliers

Last updated: February 19, 2026

Lorazepam drug substance is primarily manufactured by a limited number of global chemical and pharmaceutical companies. Supply chain stability is influenced by regulatory compliance, manufacturing capacity, and the geopolitical landscape. Key suppliers operate under stringent Good Manufacturing Practices (GMP) enforced by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Who Are the Primary Manufacturers of Lorazepam Drug Substance?

The production of lorazepam drug substance is concentrated among a select group of companies with specialized chemical synthesis capabilities. These manufacturers are subject to rigorous quality control and regulatory oversight.

• Teva Pharmaceuticals Industries Ltd. is a significant supplier of active pharmaceutical ingredients (APIs), including lorazepam. Teva operates multiple manufacturing sites globally and has a strong track record in generic drug production. Their API division is a key component of their business, serving both internal needs and external pharmaceutical companies.
• Sun Pharmaceutical Industries Ltd. is another major player in the global pharmaceutical market and a producer of lorazepam API. Sun Pharma has expanded its API manufacturing capacity through organic growth and strategic acquisitions, positioning itself as a reliable supplier.
• Alkem Laboratories Ltd. manufactures a range of APIs, including lorazepam. Alkem emphasizes its commitment to quality and regulatory compliance, holding certifications from various international health authorities.
• Amneal Pharmaceuticals LLC is involved in the manufacturing of lorazepam API. Amneal's strategy includes backward integration for key APIs to ensure supply chain control and cost-effectiveness.
• Divi's Laboratories Limited is a prominent Indian API manufacturer that produces lorazepam. Divi's is known for its large-scale manufacturing capabilities and adherence to international quality standards.

This list represents a sample of key manufacturers. The actual number of suppliers can fluctuate based on market demand, patent status, and regulatory approvals. Companies often specialize in specific therapeutic areas or chemical synthesis pathways.

What is the Manufacturing Process for Lorazepam Drug Substance?

The synthesis of lorazepam involves multi-step organic chemistry reactions. The process typically begins with a precursor molecule and proceeds through several intermediate stages, culminating in the final lorazepam API. Key steps include halogenation, cyclization, and oxidation reactions.

A common synthetic route involves starting materials such as 2-amino-5-chlorobenzophenone. The synthesis proceeds through intermediates like 7-chloro-1,3-dihydro-5-(2-chlorophenyl)-2H-1,4-benzodiazepin-2-one, followed by hydroxylation and subsequent acetylation or other modifications to yield lorazepam. The precise sequence and reagents used can vary between manufacturers, often protected as proprietary process improvements.

The manufacturing process must adhere to strict GMP guidelines to ensure the purity, potency, and consistency of the final API. This includes:

• Raw Material Control: Sourcing and testing of all starting materials and reagents.
• In-Process Controls: Monitoring critical parameters at each synthesis stage.
• Isolation and Purification: Techniques such as crystallization and chromatography are used to isolate and purify the API to pharmaceutical grade.
• Analytical Testing: Comprehensive testing of the final API for identity, purity, assay, and residual solvents, typically using High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR) spectroscopy.
• Stability Studies: Assessing the API's degradation profile under various storage conditions.

What are the Regulatory Requirements for Lorazepam API Production?

The production of lorazepam API is heavily regulated by national and international health authorities. Manufacturers must comply with current Good Manufacturing Practices (cGMP) as defined by organizations like the FDA and EMA.

Key regulatory aspects include:

• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains detailed information about the manufacturing process, facilities, quality control procedures, and stability of the API. Pharmaceutical companies reference these DMFs in their drug product applications.
• Facility Inspections: Manufacturing sites are subject to periodic inspections by regulatory authorities to ensure ongoing compliance with cGMP.
• ICH Guidelines: Compliance with guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is essential. This includes guidelines on quality, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
• Impurity Profiling: Rigorous identification and control of process-related impurities and degradation products are mandatory. Limits for impurities are set by pharmacopoeias (e.g., USP, EP) and regulatory guidelines.
• Batch Release Testing: Each batch of API must undergo stringent testing to confirm it meets predetermined specifications before it can be released for use in finished drug products.

A Certificate of Analysis (CoA) accompanies each batch of API, detailing the results of all specified tests.

What Factors Influence the Global Supply of Lorazepam Drug Substance?

Several factors influence the availability and cost of lorazepam drug substance on the global market.

• Manufacturing Capacity and Utilization: The installed manufacturing capacity of key suppliers and their current utilization rates directly impact supply. Expansion projects or the decommissioning of older facilities can shift the supply landscape.
• Raw Material Availability and Cost: The availability and price of key starting materials and reagents used in lorazepam synthesis can affect production costs and supply reliability. Geopolitical events or supply chain disruptions impacting these raw materials can have a ripple effect.
• Regulatory Compliance and Audits: Maintaining continuous compliance with cGMP and passing regulatory audits are critical. A lapse in compliance can lead to manufacturing halts or import alerts, severely impacting supply. For example, an FDA import alert can prevent API from a specific facility from entering the U.S. market.
• Intellectual Property and Patent Expiries: While lorazepam itself is an older drug with expired composition of matter patents, process patents related to novel or improved manufacturing methods can still influence which manufacturers can use specific efficient synthesis routes.
• Geopolitical Stability and Trade Policies: Production is concentrated in regions with significant chemical manufacturing infrastructure. Political instability, trade disputes, or changes in import/export regulations in these regions can disrupt the global supply chain.
• Environmental Regulations: Stricter environmental regulations in manufacturing countries can increase production costs or necessitate process modifications, potentially impacting supply or pricing.

How Does the Supply Chain for Lorazepam API Compare to Other Benzodiazepines?

The supply chain for lorazepam API shares many characteristics with that of other benzodiazepine APIs, such as diazepam, alprazolam, and clonazepam.

• Similar Manufacturing Complexity: The synthesis pathways for most benzodiazepines involve multi-step organic reactions, requiring specialized chemical expertise and infrastructure, similar to lorazepam.
• Concentrated Supplier Base: Like lorazepam, the production of many other benzodiazepine APIs is concentrated among a relatively small number of global API manufacturers.
• High Regulatory Scrutiny: All benzodiazepines are controlled substances in many jurisdictions, leading to heightened regulatory oversight not only for the finished drug product but also for the API manufacturing process, including security measures to prevent diversion.
• Raw Material Dependence: The availability and cost of common chemical precursors used across the benzodiazepine class can influence the supply and pricing of multiple APIs simultaneously.
• Market Dynamics: The demand for benzodiazepines is driven by factors like the prevalence of anxiety disorders, epilepsy, and insomnia. Changes in prescribing patterns or the development of alternative therapies can impact the demand for the APIs.
• Genericization: The majority of benzodiazepine APIs, including lorazepam, are off-patent, leading to a highly competitive generic market for both APIs and finished dosage forms. This competition drives efficiency in manufacturing and supply.

However, specific market dynamics for lorazepam can differ due to its unique therapeutic applications, dosage strengths, and regional market penetration.

What Are the Potential Risks to the Lorazepam Drug Substance Supply Chain?

The supply chain for lorazepam drug substance faces several potential risks that could lead to shortages or price volatility.

• Regulatory Non-Compliance: A single major supplier facing regulatory action (e.g., FDA warning letter, import ban) can significantly disrupt the market, especially if that supplier holds a substantial market share.
• Geological and Environmental Disasters: Manufacturing facilities in regions prone to natural disasters (earthquakes, floods) are vulnerable. Such events can lead to temporary or prolonged production stoppages.
• Raw Material Shortages or Price Spikes: Disruptions in the supply of critical starting materials or reagents, often sourced from a limited number of global suppliers, can halt API production. For example, a shortage of a specific solvent or catalyst could halt synthesis.
• Geopolitical Instability and Trade Wars: Trade tariffs, sanctions, or political unrest in key manufacturing countries can impede the flow of goods and increase costs.
• Quality Control Failures: A significant quality issue discovered during regulatory inspection or by a customer could lead to the recall of API batches and a halt in production pending investigation and remediation.
• Consolidation Among Suppliers: If mergers or acquisitions lead to fewer major API manufacturers, it can reduce competition and potentially increase supply chain fragility if one entity experiences production issues.
• Cybersecurity Threats: As manufacturing becomes more digitized, cyberattacks on production control systems or quality management systems could disrupt operations.

How Can Pharmaceutical Companies Mitigate Supply Chain Risks for Lorazepam API?

Pharmaceutical companies that rely on lorazepam API can implement several strategies to mitigate supply chain risks.

• Supplier Diversification: Qualifying and maintaining relationships with multiple API suppliers across different geographic regions can provide flexibility and reduce dependence on any single source. This might involve dual sourcing for critical APIs.
• Dual Sourcing and Inventory Management: Maintaining safety stock of the API or critical intermediates can buffer against short-term disruptions. This requires careful inventory management to balance costs with risk mitigation.
• Strategic Partnerships and Long-Term Contracts: Developing strong relationships with key suppliers through long-term supply agreements can provide greater visibility into their production plans and ensure preferential allocation during times of scarcity.
• Enhanced Due Diligence and Auditing: Conducting regular and thorough audits of API manufacturers' facilities, quality systems, and regulatory compliance records is crucial. This includes assessing their business continuity plans.
• Supply Chain Mapping and Transparency: Understanding the entire supply chain, including the sources of key raw materials for the API, can identify vulnerabilities further upstream.
• Contingency Planning: Developing detailed contingency plans for various disruption scenarios, including alternative sourcing options and expedited shipping protocols, can improve response times.
• Monitoring Regulatory and Geopolitical Landscapes: Proactively tracking regulatory changes, political developments, and economic trends in key manufacturing regions can help anticipate potential supply issues.

Key Takeaways

• Lorazepam drug substance is manufactured by a concentrated group of global API producers, including Teva Pharmaceuticals, Sun Pharmaceutical Industries, Alkem Laboratories, Amneal Pharmaceuticals, and Divi's Laboratories.
• The synthesis of lorazepam is a multi-step organic process requiring adherence to strict cGMP standards and is heavily regulated by health authorities like the FDA and EMA.
• Key factors influencing supply include manufacturing capacity, raw material availability, regulatory compliance, and geopolitical stability.
• The lorazepam API supply chain shares similarities with other benzodiazepines, characterized by complex synthesis, a concentrated supplier base, and high regulatory scrutiny.
• Potential risks include regulatory non-compliance, raw material shortages, geopolitical instability, and quality control failures.
• Mitigation strategies for pharmaceutical companies involve supplier diversification, robust inventory management, strategic partnerships, and proactive risk monitoring.

FAQs

1. What is the typical lead time for sourcing lorazepam drug substance from a new supplier? Lead times for sourcing lorazepam drug substance from a new supplier can range from 3 to 9 months. This period accounts for supplier qualification, manufacturing site audits, quality agreement finalization, initial batch production, and regulatory filing (e.g., DMF updates or new drug application amendments).
2. Are there specific geographical regions that dominate lorazepam API production? Yes, a significant portion of lorazepam API production is concentrated in India and, to a lesser extent, China, which are major global hubs for chemical synthesis and API manufacturing due to cost advantages and established infrastructure. European manufacturers also contribute, often focusing on specialized or higher-value APIs.
3. What is the typical purity specification for pharmaceutical-grade lorazepam API? Pharmaceutical-grade lorazepam API typically requires a purity of not less than 99.0% and not more than 101.0% on an anhydrous basis, as per pharmacopoeial standards (e.g., United States Pharmacopeia - USP, European Pharmacopoeia - EP). Specific impurity limits are also strictly defined.
4. How frequently are API manufacturing sites for lorazepam audited by regulatory bodies? Regulatory bodies like the FDA and EMA conduct routine GMP inspections of API manufacturing sites. The frequency can vary, but sites supplying major markets are typically inspected every 2 to 3 years. Unscheduled inspections can occur if specific concerns arise.
5. Can the classification of lorazepam as a controlled substance impact its API supply chain logistics? Yes, the controlled substance status of lorazepam significantly impacts its API supply chain logistics. Manufacturers and distributors must comply with stringent regulations regarding security, record-keeping, licensing, and import/export controls (e.g., DEA regulations in the U.S.) to prevent diversion and ensure secure transportation and storage of the API.

Citations

[1] Teva Pharmaceutical Industries Ltd. (n.d.). API Business. Retrieved from [Manufacturer's official website – specific page not publicly available or generalized] [2] Sun Pharmaceutical Industries Ltd. (n.d.). API Division. Retrieved from [Manufacturer's official website – specific page not publicly available or generalized] [3] Alkem Laboratories Ltd. (n.d.). API Business. Retrieved from [Manufacturer's official website – specific page not publicly available or generalized] [4] Amneal Pharmaceuticals LLC. (n.d.). API Manufacturing. Retrieved from [Manufacturer's official website – specific page not publicly available or generalized] [5] Divi's Laboratories Limited. (n.d.). Products. Retrieved from [Manufacturer's official website – specific page not publicly available or generalized] [6] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1999). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. [7] United States Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA official website] [8] European Medicines Agency. (n.d.). Active substances (AS). Retrieved from [EMA official website]