Vilazodone (Viibryd) Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Vilazodone (Viibryd) Manufacturing Plant Project Report 2024 Edition: Industry Trends, Capital Investment, Price Trends, Manufacturing Process, Raw Materials Requirement, Plant Setup, Operating Cost, and Revenue Statistics,” provides an in-depth and comprehensive examination of the financial and operational aspects of establishing vilazodone (Viibryd) plant.

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends, including the effects of COVID-19 on both global and regional scales. It profiles key industry players, giving insights into their market strategies, production capacities, and financial performance, which are crucial for benchmarking and competitive analysis.

It delves into historical, current, and forecasted price trends, helping stakeholders understand market dynamics and price volatility. The report provides a thorough analysis of the mass balance and raw materials requirements, ensuring a clear understanding of the input-output ratios essential for efficient production. Detailed examinations of the various unit operations integral to the vilazodone (Viibryd) manufacturing process are included, highlighting process optimisation techniques and technological advancements.

The report presents a comprehensive capital cost analysis, detailing the financial investment required for setting up a vilazodone (Viibryd) plant. This includes an exhaustive breakdown of costs associated with raw materials, catchem, utilities, labour, packaging, transportation, land acquisition, construction, and machinery. Additionally, it offers an in-depth look at the operating costs, providing clarity on the recurring expenses involved in running the plant.

Projected profit margins and optimal product pricing strategies are outlined, offering guidance on maximising profitability. The report also addresses regulatory frameworks, environmental impacts, and sustainability measures pertinent to the vilazodone (Viibryd) industry.

About Vilazodone (Viibryd)

Vilazodone (Viibryd) is an antidepressant medication used to treat major depressive disorder in adults. It works by inhibiting serotonin reuptake and partially agonizing 5-HT1A receptors. Viibryd is taken once daily with food. Vilazodone was approved by the FDA in 2011 as a novel antidepressant option. Vilazodone has a boxed warning for an increased risk of suicidal thoughts and behaviours in certain people, especially those under 25. Dosage can range from 10-80 mg/day, depending on individual response and potential drug interactions.

Properties of Vilazodone (Viibryd)

Vilazodone is the active pharmaceutical ingredient (API) in the antidepressant medication Viibryd. The API is a white to cream-colored solid that exists in multiple polymorphic forms, with Form IV chosen for commercial development. It is taken once daily with food, starting at 10 mg and titrating up to 40 mg. Vilazodone has a bioavailability of 72%, an elimination half-life of 25 hours, and a solubility of 0.32 mg/mL in water at 20°C. Common side effects include nausea, diarrhoea, and insomnia, while serious potential side effects involve increased suicidal thoughts, serotonin syndrome, and bleeding. Vilazodone may offer advantages over other antidepressants by causing less emotional blunting.

Manufacturing Process of Vilazodone (Viibryd)

Key steps in the manufacturing process of Vilazodone include reacting a compound of formula II with a source of ammonia to obtain the Vilazodone base. This base is then converted to its hydrochloride salt form. The Vilazodone active pharmaceutical ingredient (API) is formulated into 10 mg, 20 mg, and 40 mg oral tablets by combining the API with excipients such as microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, and Opadry II. Stability studies have been conducted on batches of the API and drug product to support the commercial manufacturing process and formulation. The finished tablets are packaged for distribution as the prescription medication Viibryd.

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Synthesis of Vilazodone (Viibryd)

Step 1: Synthesis of 5-Bromo-1H-indole

1. Starting Materials:

• Indole: C₈H₇N

• N-Bromosuccinimide (NBS): C₄H₄BrNO₂

2. Reaction:

• Indole reacts with NBS in the presence of a suitable solvent (like DMF) and a catalyst (such as AIBN) to form 5-Bromo-1H-indole.

• C₈H₇N + C₄H₄BrNO₂ → C₈H₆BrN + C₄H₅NO₂

Step 2: Synthesis of 5-(4-Chlorobutyl)-1H-indole

1. Starting Materials:

• 5-Bromo-1H-indole: C₈H₆BrN

• 1,4-Dibromobutane: C₄H₆Br₂

2. Reaction:

• 5-Bromo-1H-indole reacts with 1,4-Dibromobutane in the presence of a base (like KOH) to form 5-(4-Bromobutyl)-1H-indole.

• C₈H₆BrN + C₄H₆Br₂ → C₁₂H₁₃Br₂N

• Further substitution with KCl leads to the formation of 5-(4-Chlorobutyl)-1H-indole.

• C₁₂H₁₃Br₂N + KCl → C₁₂H₁₃ClN + KBr

Step 3: Synthesis of 5-(4-Chlorobutyl)-1H-indol-3-yl Acetate

1. Starting Materials:

• 5-(4-Chlorobutyl)-1H-indole: C₁₂H₁₃ClN

• Acetic anhydride: C₄H₆O₃

2. Reaction:

• 5-(4-Chlorobutyl)-1H-indole reacts with acetic anhydride to form 5-(4-Chlorobutyl)-1H-indol-3-yl acetate.

• C₁₂H₁₃ClN + C₄H₆O₃ → C₁₄H₁₅ClNO₂

Step 4: Synthesis of Vilazodone

1. Starting Materials:

• 5-(4-Chlorobutyl)-1H-indol-3-yl acetate: C₁₄H₁₅ClNO₂

• 8-(Piperazin-1-yl)-2,3-dihydrobenzofuran-5-carboxamide: C₁₄H₁₅N₃O₂

2. Reaction:

• 5-(4-Chlorobutyl)-1H-indol-3-yl acetate reacts with 8-(Piperazin-1-yl)-2,3-dihydrobenzofuran-5-carboxamide in the presence of a suitable base (like NaOH) to form Vilazodone.

• C₁₄H₁₅ClNO₂ + C₁₄H₁₅N₃O₂ → C₂₆H₂₇ClN₄O₂ + C₂H₄O₂

Final Product:

Vilazodone (Viibryd), with a chemical formula of C₂₆H₂₇ClN₄O₂.

Applications and Drivers of Vilazodone (Viibryd)

Vilazodone (Viibryd) is an antidepressant medication used to treat major depressive disorder (MDD), which is a common and debilitating mental health condition, affecting around 121 million people worldwide.  Market analysis indicates the vilazodone/Viibryd market is expected to grow annually with a high growth rate, driven by factors like the high prevalence of depression and the need for new treatment options.

Key Features of the Vilazodone (Viibryd) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the vilazodone (Viibryd) manufacturing process, offering a comprehensive overview necessary for stakeholders considering venturing into this sector. Based on the latest economic data, the report encompasses detailed insights into the primary process flow, raw material requirements, reactions involved, utility costs, operating costs, capital investments, pricing strategies, and profit margins. This report is an indispensable resource for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake in the vilazodone (Viibryd) industry. It equips them with essential information and strategic insights to effectively navigate the complexities of the market.

The following sections detail the comprehensive scope of the prefeasibility report for a vilazodone (Viibryd) production plant:

• Market Dynamics and Trends: This section analyses the prevailing market conditions, growth drivers, and trends impacting the vilazodone (Viibryd) industry. It offers a thorough examination of demand fluctuations and projections.

• Impact of COVID-19: An assessment of how the pandemic has affected industry operations, supply chains, and overall market dynamics.

• Geographic Analysis: Detailed insights into the major regions active in vilazodone (Viibryd) production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the vilazodone (Viibryd) sector, outlining their market share, strategic positions, and operational strengths.

• Price Fluctuations: Analysis of historical, current, and projected price trends, providing stakeholders with essential pricing intelligence.

• Technical Specifications and Process Description: A detailed overview of the vilazodone (Viibryd) production process including the technology used and innovations within the industry.

• Raw Material Requirements and Sourcing: Evaluation of necessary raw materials, their sourcing strategies, and cost implications.

• Utility Requirements and Costs: Detailed analysis of utilities needed to produce vilazodone (Viibryd), such as electricity, steam, and process water along with their cost assessments. 

• Labour Force Dynamics: Insights into manpower requirements, including skill specifications and labour cost projections.

• Packaging Needs: Overview of packaging requirements for vilazodone (Viibryd) to ensure product integrity and cost efficiency.

• Logistics and Transportation: Examination of transportation needs and logistics planning for distribution and supply chain efficiency.

• Capital and Operating Costs: An in-depth look at investment requirements, including land acquisition and its development cost, civil work costs, construction, machinery procurement, and ongoing operational expenses, such as salaries and wages, plant overheads, tax and insurance as well as packaging, transportation, and administration costs.

• Financial Performance and Profitability Analysis: Projected profit margins and return on investment based on current market and operational parameters.

• Product Pricing Strategy: Recommendations on pricing mechanisms based on industry benchmarks and production costs.

• Environmental Impact and Regulatory Compliance: Analysis of environmental considerations and compliance with local and international regulations.

• Risk Assessment and Mitigation Strategies: Identification of potential risks associated with vilazodone (Viibryd) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for vilazodone (Viibryd) production?

• Who are major technology licensors with their process evaluation?

• How are raw materials or catchem procured and what are their cost implications?

• What utilities are essential for production and what will they cost?

• What are the labour requirements and how does this affect operational costs?

• What packaging solutions are optimal for cost and efficiency?

• What logistical arrangements are necessary for efficient product distribution?

• What are the estimated land and construction costs for a new vilazodone (Viibryd) plant?

• How can profitability be maximised in the vilazodone (Viibryd) market?

• What pricing strategy should be adopted for vilazodone (Viibryd) to remain competitive?

This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the vilazodone (Viibryd) industry.