Iloperidone (Fanapt) Manufacturing Plant Project Report 2024

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends. 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 Iloperidone (Fanapt) 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 Iloperidone (Fanapt) 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 Iloperidone (Fanapt) industry.

About Iloperidone (Fanapt)

Iloperidone (Fanapt) is an atypical antipsychotic medication approved for the treatment of schizophrenia in adults. It works by antagonising dopamine and serotonin receptors in the brain. Iloperidone was initially developed by Hoechst Marion Roussel, then later acquired by Titan Pharmaceuticals, Novartis, and Vanda Pharmaceuticals. The FDA approved iloperidone for schizophrenia in 2009 and more recently for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Properties of Iloperidone (Fanapt)

Iloperidone (Fanapt) is a white to off-white finely crystalline powder that is practically insoluble in water, very slightly soluble in 0.1 N HCl, and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone has an average molecular weight of 426.48 and a chemical formula of C24H27FN2O4. It acts as an antagonist at serotonin 5-HT2A, dopamine D2 and D3, and norepinephrine α1 receptors, with moderate affinity for other receptors. Iloperidone is metabolised primarily by CYP2D6 and CYP3A4, with an elimination half-life of 18-33 hours.

Manufacturing Process of Iloperidone (Fanapt)

The synthesis begins with the reaction of tetrabutyl ammonium bromide, potassium hydroxide, 1-[4-(3-chloropropoxy)-3-methoxyphenyl] ethenone, and 6-fluoro-3-piperidin-4-yl-1,2-benzisoxazole hydrochloride. This mixture is stirred and heated to produce the crude iloperidone product, which is then purified by dissolution in isopropyl alcohol, decolourisation, and recrystallisation.

The purified iloperidone is then formulated into an amorphous co-precipitate with the polymer povidone (PVP K30). This is achieved by dissolving the iloperidone and povidone in dichloromethane, filtering the solution, and removing the solvent under vacuum. The resulting amorphous co-precipitate is confirmed by X-ray diffraction analysis. Finally, the iloperidone product and its hydrochloride and fumarate salts undergo thorough characterisation. This includes analysis of purity, yield, and impurity profiles, which are reported in detailed tables.

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Synthesis of Iloperidone (Fanapt)

The production of iloperidone involves the following chemical synthesis steps:

1. Synthesis of Key Intermediates

The synthesis of iloperidone starts with the preparation of key intermediates. One of the primary intermediates is 6-fluoro-1,2-benzoxazole, which is produced as follows:

1.1 Synthesis of 6-Fluoro-1,2-Benzoxazole

6-Fluoro-1,2-benzoxazole is synthesised from 2-fluoroaniline and carbonyl diimidazole:

C6H4FN + C7H6N2O2 -> C7H4FNO + C3H4N2

2. Formation of Iloperidone

The synthesis of iloperidone involves the reaction of 6-fluoro-1,2-benzoxazole with 1-[4-(3-chloropropoxy)-3-methoxyphenyl]piperazine. This multi-step process can be summarised as follows:

2.1 Reaction with 1-[4-(3-Chloropropoxy)-3-Methoxyphenyl]piperazine

The key intermediate 6-fluoro-1,2-benzoxazole reacts with 1-[4-(3-chloropropoxy)-3-methoxyphenyl] piperazine to form an intermediate compound:

C7H4FNO + C14H21ClN2O2 -> Intermediate

2.2 Cyclisation and Formation of Iloperidone

The intermediate undergoes cyclisation and further reactions to form iloperidone. The final step involves the following reaction:

Intermediate + C8H8ClNO -> Iloperidone (C24H27ClFN3O4)

3. Purification and Formulation

After the synthesis, iloperidone is purified through recrystallisation or chromatography to achieve the desired purity. The purified iloperidone is then formulated into the final pharmaceutical product, such as tablets or capsules, ready for use.

Applications and Drivers of Iloperidone (Fanapt)

The key applications of iloperidone, marketed under the brand name Fanapt, include treating psychotic symptoms in patients with schizophrenia. Iloperidone has been shown to be effective in improving symptoms like hallucinations, delusions, and disorganised thinking in clinical trials, making it a valuable treatment option for managing schizophrenia.  Additionally, pharmacogenomic studies have identified genetic factors associated with enhanced response to iloperidone during acute treatment of schizophrenia.

The main drivers of the iloperidone (Fanapt) market include the growing prevalence of schizophrenia globally, the need for effective antipsychotic medications to manage the condition, and the drug's favourable pharmacokinetic profile compared to other atypical antipsychotics.  Iloperidone's high oral bioavailability, long half-life, and low risk of certain side effects like weight gain and metabolic changes make it an attractive treatment option for healthcare providers and patients.

Key Features of the Iloperidone (Fanapt) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the Iloperidone (Fanapt) 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 Iloperidone (Fanapt) 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 Iloperidone (Fanapt) production plant:

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

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

• Key Industry Players: Profiles of leading manufacturers in the Iloperidone (Fanapt) 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 Iloperidone (Fanapt) 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 Iloperidone (Fanapt), 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 Iloperidone (Fanapt) 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 Iloperidone (Fanapt) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for Iloperidone (Fanapt) 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 Iloperidone (Fanapt) plant?

• How can profitability be maximised in the Iloperidone (Fanapt) market?

• What pricing strategy should be adopted for Iloperidone (Fanapt) to remain competitive?

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