Vortioxetine Hydrobromide Manufacturing Plant Project Report 2025: Market by Region, Market by Application, Key Players, Pre-feasibility, Capital Investment Costs, Production Cost Analysis, Expenditure Projections, Return on Investment (ROI), Economic Feasibility, CAPEX, OPEX, Plant Machinery Cost

Vortioxetine Hydrobromide Manufacturing Plant Project Report 2025: Cost Analysis, ROI, and Feasibility Insights

Vortioxetine Hydrobromide Manufacturing Plant Project Report by Procurement Resource thoroughly focuses on every detail that encompasses the cost of manufacturing. Our extensive cost model meticulously covers breaking down Vortioxetine Hydrobromide plant capital cost around raw materials, labour, technology, and manufacturing expenses. This enables precise cost structure optimization and helps in identifying effective strategies to reduce the overall Vortioxetine Hydrobromide manufacturing plant cost and the cash cost of manufacturing.

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Vortioxetine Hydrobromide is an organic chemical compound and an active pharmaceutical ingredient (API) with the chemical formula C18H22N2S⋅HBr or C18H23BrN2S. It exists in the form of a white to off-white crystalline powder. Vortioxetine hydrobromide is primarily used as a novel antidepressant for the treatment of major depressive disorder (MDD) and other related mental health conditions. Its unique mechanism of action, which involves multi-modal activity on the serotonin system, makes it an essential drug in the pharmaceutical and healthcare sectors worldwide.
 

Applications of Vortioxetine Hydrobromide

Vortioxetine hydrobromide finds significant applications in the following key industries:

• Pharmaceuticals (Antidepressant): Vortioxetine hydrobromide is extensively used as an active pharmaceutical ingredient (API) in medications to treat major depressive disorder (MDD) in adults. It works as a serotonin modulator and stimulator (SMS), inhibiting the serotonin transporter (SERT) and modulating various serotonin receptors. This unique multi-modal activity provides both antidepressant and anxiolytic effects and has also been shown to improve cognitive symptoms associated with depression.
• Psychiatric Disorders: Vortioxetine hydrobromide is also used to treat a variety of psychiatric disorders, including generalised anxiety disorder and other related mental health conditions.
• Research and Development: Vortioxetine hydrobromide and its related compounds are subjects of ongoing research for their potential therapeutic applications in new therapeutic areas, including cognitive enhancement and other neurological disorders.
   

Top Manufacturers of Vortioxetine Hydrobromide

The global vortioxetine hydrobromide market is served by a number of pharmaceutical and API manufacturers. Leading global manufacturers include:

• Lundbeck Limited
• Takeda Pharmaceutical Company Limited
• Teva Pharmaceutical Industries Ltd
• Sun Pharmaceutical Industries Ltd
• Zydus Group
• Mylan N.V. (now part of Viatris)
   

Feedstock and Raw Material Dynamics for Vortioxetine Hydrobromide Manufacturing

The primary feedstocks for industrial Vortioxetine Hydrobromide manufacturing are 2,4-Dimethylbenzenethiol, o-iodobromobenzene, piperazine, and hydrobromic acid. Evaluating the value chain and market conditions of vortioxetine hydrobromide is essential for analysing manufacturing costs and plant economics.

• 2,4-Dimethylbenzenethiol (C8H10S): This is a key precursor. It is a highly specialised organic compound. Its synthesis involves multiple steps, contributing to its relatively high cost. Prices for high-purity 2,4-Dimethylbenzenethiol can vary significantly for research or fine chemical grades. Industrial procurement of high-purity 2,4-Dimethylbenzenethiol is crucial, as it forms the benzothiol backbone of the vortioxetine molecule. Fluctuations in its price directly impact the overall manufacturing expenses and the cash cost of production for vortioxetine hydrobromide.
• o-Iodobromobenzene (C6H4BrI): It is another specialised organic compound. Its synthesis involves multiple steps, contributing to its relatively high cost. Industrial procurement of high-purity o-iodobromobenzene is essential for the reaction, and its cost is a significant contributor to the operating expenses and the overall production cost analysis for vortioxetine hydrobromide.
• Piperazine (C4H10N2): Piperazine is a cyclic organic amine. It is generally produced by the reaction of ethylene dichloride and ammonia. Global prices for piperazine are influenced by feedstock costs and demand from the pharmaceutical, polymer, and chemical industries. Industrial procurement of high-purity piperazine is crucial for the reaction.
• Hydrobromic Acid (HBr): Hydrobromic acid is a strong acid used in the final step to form the hydrobromide salt. The global hydrobromic acid market is influenced by the demand from various industries, including pharmaceuticals, dyes, and speciality chemicals. Its prices are also influenced by bromine feedstock costs and logistics disruptions.
   

Market Drivers for Vortioxetine Hydrobromide

The market for Vortioxetine hydrobromide is predominantly driven by its demand as an antidepressant for the treatment of major depressive disorder.

• Increasing Prevalence of Depression and Anxiety Disorders: The increasing prevalence of depression and anxiety disorders globally is a major driver of this market. The rising global prevalence of depression, anxiety disorders, and other related mental health conditions is driving the demand for effective antidepressant therapies. Vortioxetine's unique multi-modal activity on the serotonin system, which provides both antidepressant and anxiolytic effects, makes it a preferred treatment option, ensuring its robust consumption.
• Unique Mechanism of Action: Vortioxetine's unique mechanism of action, which involves modulating various serotonin receptors, has led to a better side-effect profile compared to other antidepressants. This makes it a preferred choice for healthcare professionals and patients, which ensures its robust consumption.
• Growing Geriatric Population: The global population is getting older, and mental health conditions are more common among the elderly. As the world's population ages, there will be a greater need for medications to treat depression and anxiety disorders, ensuring a sustained demand for vortioxetine hydrobromide.
• Global Investments in Healthcare Infrastructure: The continuous expansion and improvement of healthcare infrastructure globally, particularly in emerging economies, are increasing access to advanced medical treatments. This translates into a greater number of patients being diagnosed and treated for depression, thereby boosting the demand for vortioxetine hydrobromide.
• Technological Advancements: Ongoing research and development in drug formulation and manufacturing processes are leading to new and improved vortioxetine hydrobromide products with enhanced efficacy and better side-effect profiles. These innovations are expanding the material's applications and improving its performance in various industrial settings. Growth in pharmaceutical manufacturing and rising investments in central nervous system (CNS) therapies are increasing demand for Vortioxetine Hydrobromide, an antidepressant active pharmaceutical ingredient.
• Global Pharmaceutical Market Growth: The market is primarily driven by the increasing prevalence of depressive disorders, rising awareness about mental health, and the expanding adoption of novel antidepressant therapies worldwide. Overall growth in the global pharmaceutical market, driven by increasing healthcare expenditure and demand for generic medications, ensures a sustained market for essential APIs like vortioxetine hydrobromide. This directly influences the total capital expenditure (CAPEX) for establishing a new Vortioxetine Hydrobromide plant capital cost.
   

CAPEX and OPEX in Vortioxetine Hydrobromide Manufacturing

Making Vortioxetine hydrobromide on a commercial scale involves heavy capital costs for the plant and significant operating expenses.
 

CAPEX (Capital Expenditure):

The Vortioxetine Hydrobromide plant capital cost covers investment in pharmaceutical-grade synthesis reactors, purification equipment, and quality control laboratories. Its components cover:

• Land and Site Preparation: Expenses include securing industrial land and readying it for construction, from levelling and foundation work to utility connections. Since production uses rare and costly raw materials, specialised safety features and secure handling facilities are essential.
• Building and Infrastructure: Construction of specialised reaction halls, purification areas, filtration and drying sections, clean rooms for final product handling and packaging (to meet pharmaceutical standards), raw material storage, advanced analytical laboratories, and administrative offices. Buildings must adhere to stringent pharmaceutical GMP guidelines.
• Reactors/Reaction Vessels: Corrosion-resistant reactors equipped with powerful agitators, heating/cooling jackets, and reflux condensers. These vessels are crucial for the multi-step synthesis of vortioxetine hydrobromide and must be designed for safe handling of reactive and toxic chemicals.
• Raw Material Dosing Systems: Automated and sealed dosing systems for precise and safe feeding of 2,4-Dimethylbenzenethiol, o-iodobromobenzene, piperazine, and hydrobromic acid into the reactor, ensuring accurate stoichiometry and controlled reactions.
• Heating and Cooling Systems: Jacketed reactors, heat exchangers, and steam/hot oil generators for heating reactions, and chillers/cooling towers for cooling, which are crucial for controlling the exothermic reactions and for subsequent purification steps.
• Filtration and Purification Equipment: Specialised filters (e.g., filter presses, centrifuges) to separate crude intermediates and the final solid vortioxetine hydrobromide product from liquid phases. Multiple purification stages, involving recrystallisation from solvents like methanol and acetonitrile, will be required to achieve API purity.
• Drying Equipment: Specialised industrial dryers (e.g., vacuum tray dryers, fluid bed dryers) designed for handling heat-sensitive pharmaceutical powders, ensuring low moisture content and product stability. Drying often occurs under a controlled vacuum or inert atmosphere.
• Grinding/Milling and Screening Equipment: Mills (e.g., conical mills, hammer mills) and sieving equipment for achieving the desired particle size distribution and uniformity of the final powder or granules, often in a controlled environment.
• Storage Tanks/Cylinders: Dedicated, sealed, and often temperature-controlled storage tanks for bulk liquid raw materials, and pressure-rated cylinders for gaseous reagents. Clean, climate-controlled storage for the final API product.
• Pumps and Piping Networks: Networks of chemical-resistant and leak-proof pumps and piping for transferring raw materials, intermediates, solutions, and slurries throughout the plant.
• Utilities and Support Systems: Installation of robust electrical power distribution, industrial cooling water systems, steam generators (boilers for heating), compressed air systems, and purified water systems (e.g., WFI - Water For Injection).
• Control Systems and Instrumentation: Highly advanced DCS (Distributed Control Systems) or PLC-based systems with sophisticated process control loops, extensive temperature, pressure, pH, flow, and level sensors, specialised gas detectors, and multiple layers of safety interlocks and emergency shutdown systems. These are critical for precise control, optimising yield, and ensuring the highest level of safety due to hazardous chemicals and pharmaceutical quality requirements.
• Quality Control Laboratory Equipment: Extensive and highly sophisticated analytical equipment (e.g., HPLC, GC-MS, FTIR, NMR, Karl Fischer titrators, dissolution testers) for raw material testing, in-process control, and finished product release, crucial for compliance with global pharmacopoeial standards (USP, EP, BP).
• Pollution Control Equipment: High-performance scrubbers for toxic or corrosive gas emissions, VOC abatement systems for solvent vapours, and advanced effluent treatment plants (ETP) to manage process wastewater are essential for meeting strict environmental standards. This entails a considerable investment that influences the overall Vortioxetine Hydrobromide manufacturing plant cost.
   

OPEX (Operating Expenses):

Operating expenses include the cost of buying expensive raw materials, solvents, skilled labour, strict quality assurance, and regulatory compliance. Major components are explained below:

• Raw Material Costs: The main cost driver is the purchase of 2,4-dimethylbenzenethiol, o-iodobromobenzene, piperazine, hydrobromic acid, and other reagents. Shifts in their prices raise or lower production costs and cost per metric ton (USD/MT). Specialised intermediates also add significantly to the expense.
• Energy Costs: Significant electricity consumption for pumps, mixers, dryers, and distillation units, along with fuel or steam for heating reactors and running purification steps, results in high energy demands. The intensive heating, cooling, and separation stages have a major impact on the Vortioxetine hydrobromide production cost analysis.
• Labour Costs: Wages, salaries, benefits, and specialised training costs for a highly skilled workforce, including pharmaceutical production operators, organic synthesis chemists, quality assurance/control personnel, maintenance technicians, and engineers. Due to stringent GMP requirements and handling of hazardous APIs, labour costs are significantly higher.
• Utilities: Ongoing costs for process water (especially purified water), cooling water, and compressed air.
• Maintenance and Repairs: Expenses for routine preventative maintenance, periodic inspection and repair of glass-lined reactors, pressure vessels, and high-purity filtration/drying equipment.
• Packaging Costs: The recurring expense of purchasing suitable, pharmaceutical-grade, and moisture-proof packaging materials for the final API product.
• Transportation and Logistics: Costs associated with inward logistics for raw materials and outward logistics for distributing the high-value API globally. Special handling requirements for some materials add to transportation costs.
• Fixed and Variable Costs: For Vortioxetine hydrobromide production, the cost structure includes both fixed and variable components. Fixed costs consist of depreciation on high-value equipment, property taxes, and insurance for specialised assets. Variable costs fluctuate with production levels and mainly include raw materials, energy consumed in the process, and direct labour linked to output.
• Quality Control and Regulatory Costs: Significant recurring expenses for extensive analytical testing, quality assurance, batch release, validation studies, and compliance with stringent global pharmacopoeial standards (USP, EP, BP, JP) and Good Manufacturing Practices (GMP). This includes costs for regulatory filings, audits, and managing complex regulatory frameworks, which are particularly high for pharmaceutical APIs.
• Waste Disposal Costs: Large sums are spent on proper treatment and disposal of chemical waste and wastewater during vortioxetine hydrobromide processing.  Expenses are also involved in adhering to pharmaceutical industry environmental standards.
   

Manufacturing Process

This report comprises a thorough value chain evaluation for Vortioxetine Hydrobromide manufacturing and consists of an in-depth production cost analysis revolving around industrial Vortioxetine Hydrobromide manufacturing.

• Production from 2,4-Dimethylbenzenethiol: The manufacturing process of Vortioxetine hydrobromide is a three-step organic synthesis. The production of Vortioxetine hydrobromide starts with 2,4-dimethylbenzenethiol, which is reacted with o-iodobromobenzene in the presence of a palladium catalyst and a base to form a thioether-linked intermediate. This intermediate is then taken through an amination step, where piperazine is introduced to create a piperazine-containing intermediate. As the last step, the obtained compound is treated with hydrobromic acid under ambient temperature, which leads to the formation of Vortioxetine hydrobromide as the final product.
   

Properties of Vortioxetine Hydrobromide

Vortioxetine Hydrobromide is a synthetic antidepressant, characterised by its multi-modal activity on the serotonin system.
 

Physical Properties

• Appearance: White to off-white crystalline powder.
• Odour: Odourless.
• Molecular Formula: C18H22N2S⋅HBr (Vortioxetine hydrobromide).
• Molar Mass: 379.36g/mol
• Melting Point: 165 degree Celsius (decomposes). Some sources cite a different melting point.
• Boiling Point: Approximately 485.8±55.0 degree Celsius (760 mmHg) (predicted for the free base).
• Density: 1.41g/cm3 at 20 degree Celsius (predicted).
• Flash Point: Not applicable for the solid.
   

Chemical Properties

• Serotonin Modulator and Stimulator (SMS): It acts as a serotonin modulator and stimulator (SMS), which is a novel mechanism of action for antidepressants. It inhibits the serotonin transporter (SERT) and modulates various serotonin receptors, which results in both antidepressant and anxiolytic effects.
• pH Stability: The stability of the compound in solution is pH-dependent. Its solubility in water decreases as the pH increases.
• Thermal Stability: It decomposes upon heating, releasing toxic fumes of sulfur oxides and nitrogen oxides.
• Reactivity: It is not compatible with potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin), as this can lead to serious drug interactions.
• Metabolism: It is primarily metabolised by the liver, with its metabolites being excreted in the urine.
• Spasmolytic Activity: It displays spasmolytic activity and a lower affinity for alpha-1 adrenergic receptors, which may be related to its lower incidence of cardiovascular side effects compared to other adrenergic agonists.
   

Vortioxetine Hydrobromide Manufacturing Plant Report provides you with a detailed assessment of capital investment costs (CAPEX) and operational expenses (OPEX), generally measured as cost per metric ton (USD/MT). This approach ensures that your investment decisions are aligned with the latest industry standards and economic feasibility metrics, enhancing your manufacturing efficiency and financial planning.

Apart from that, this Vortioxetine Hydrobromide manufacturing plant report also covers the leading technology providers that help you plan a robust plan of action related to Vortioxetine Hydrobromide manufacturing plant and its production process(es), and also by helping you with an in-depth supplier database. This report provides exclusive insights into the best manufacturing practices for Vortioxetine Hydrobromide and technology implementation costs. This report also covers operational cash flow, fixed and variable costs, and detailed break-even point analysis, ensuring that your manufacturing process is not only efficient but also economically viable in the competitive market landscape.

In addition to operational insights, the Vortioxetine Hydrobromide manufacturing plant report also comprehensively focuses on lifecycle cost analysis, maintenance costs, and energy consumption costs, which are critical for maintaining long-term sustainability and profitability. Our manufacturing cost analysis extends to include regulatory compliance costs, inventory holding costs, and logistics and distribution costs, providing a holistic view of the potential expenses and savings.

We at Procurement Resource ensure that this report is not only cost-efficient, environmentally sustainable, and aligned with the latest technological advancements but also that you are equipped with all necessary tools to optimize supply chain operations, manage risks effectively, and achieve superior market positioning for Vortioxetine Hydrobromide.
 

Key Insights and Report Highlights

Key Questions Covered in our Vortioxetine Hydrobromide Manufacturing Plant Report

• How can the cost of producing Vortioxetine Hydrobromide be minimized, cash costs reduced, and manufacturing expenses managed efficiently to maximize overall efficiency?
• What is the estimated Vortioxetine Hydrobromide manufacturing plant cost?
• What are the initial investment and capital expenditure requirements for setting up a Vortioxetine Hydrobromide manufacturing plant, and how do these investments affect economic feasibility and ROI?
• How do we select and integrate technology providers to optimize the production process of Vortioxetine Hydrobromide, and what are the associated implementation costs?
• How can operational cash flow be managed, and what strategies are recommended to balance fixed and variable costs during the operational phase of Vortioxetine Hydrobromide manufacturing?
• How do market price fluctuations impact the profitability and cost per metric ton (USD/MT) for Vortioxetine Hydrobromide, and what pricing strategy adjustments are necessary?
• What are the lifecycle costs and break-even points for Vortioxetine Hydrobromide manufacturing, and which production efficiency metrics are critical for success?
• What strategies are in place to optimize the supply chain and manage inventory, ensuring regulatory compliance and minimizing energy consumption costs?
• How can labor efficiency be optimized, and what measures are in place to enhance quality control and minimize material waste?
• What are the logistics and distribution costs, what financial and environmental risks are associated with entering new markets, and how can these be mitigated?
• What are the costs and benefits associated with technology upgrades, modernization, and protecting intellectual property in Vortioxetine Hydrobromide manufacturing?
• What types of insurance are required, and what are the comprehensive risk mitigation costs for Vortioxetine Hydrobromide manufacturing?