Isosorbide Mononitrate Manufacturing Plant Project Report 2025

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 isosorbide mononitrate 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 isosorbide mononitrate 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 isosorbide mononitrate industry.

About Isosorbide Mononitrate

Isosorbide mononitrate is a nitrate medication primarily used to prevent angina pectoris; a type of chest pain caused by reduced blood flow to the heart. The medication was first synthesised in the 1950s and it gained FDA approval in 1991. It works by dilating blood vessels, which eases blood flow and reduces the heart's workload. Commonly prescribed under brand names like Imdur and Monoket, it is effective for long-term management but is not suitable for acute angina attacks.

Properties of Isosorbide Mononitrate

Isosorbide mononitrate is a crystalline, white, odourless compound that is stable in air and solution. It is a nitrate vasodilator that relaxes vascular smooth muscle, especially venous vessels, via generation of nitric oxide. This reduces atrial pressure, afterload, and preload. Isosorbide mononitrate is rapidly absorbed orally, with peak plasma levels occurring about 1 hour after dosing. It is completely bioavailable. The drug is eliminated from plasma with a half-life of about 5.1 hours, primarily as unchanged drug in urine and as the metabolite isosorbide-5MN-2-glucoronide.

Manufacturing Process of Isosorbide Mononitrate

The production process of isosorbide mononitrate begins with the synthesis of isosorbide, which is derived from sorbitol. This precursor undergoes a nitration reaction, where it is treated with nitric acid and sulfuric acid to introduce the nitrate group. Following this, the product is purified and formulated into the desired dosage forms, such as tablets. Quality control tests are then conducted to ensure the product meets pharmacological standards before it is packaged for distribution.

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Synthesis of Isosorbide Mononitrate

The production of isosorbide mononitrate involves the following processes:

1. Hydrogenation of Glucose

The production process begins with the hydrogenation of glucose to produce sorbitol. The reaction is as follows:

C6H12O6 + H2 → C6H14O6

In this reaction, glucose (C6H12O6) reacts with hydrogen (H2) in the presence of a nickel catalyst to form sorbitol (C6H14O6).

2. Dehydration to Form Isosorbide

Sorbitol is then dehydrated to form isosorbide through an acid-catalysed dehydration reaction. The reaction is as follows:

C6H14O6 → C6H10O4 + 2H2O

In this reaction, sorbitol (C6H14O6) undergoes dehydration to produce isosorbide (C6H10O4) and water (H2O).

3. Nitration to Form Isosorbide Mononitrate

The isosorbide is then nitrated to form isosorbide mononitrate. The nitration reaction is:

C6H10O4 + HNO3 → C6H9NO6 + H2O

In this reaction, isosorbide (C6H10O4) reacts with nitric acid (HNO3) to produce isosorbide mononitrate (C6H9NO6) and water (H2O).

Applications and Drivers of Isosorbide Mononitrate

The isosorbide mononitrate market is driven by its critical applications in treating cardiovascular conditions, particularly angina pectoris and heart failure. As a nitrate vasodilator, it effectively relaxes blood vessels, improving blood flow and reducing heart workload. The growing prevalence of heart diseases, coupled with an ageing population, fuels demand for effective anti-anginal therapies. Additionally, the rise in healthcare spending and advancements in drug formulations, such as extended-release tablets, enhance its market growth.

Key Features of the Isosorbide Mononitrate Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the isosorbide mononitrate 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 isosorbide mononitrate 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 isosorbide mononitrate production plant:

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

• Geographic Analysis: Detailed insights into the major regions active in isosorbide mononitrate production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the isosorbide mononitrate 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 isosorbide mononitrate 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 isosorbide mononitrate, 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 isosorbide mononitrate 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 isosorbide mononitrate production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for isosorbide mononitrate 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 isosorbide mononitrate plant?

• How can profitability be maximised in the isosorbide mononitrate market?

• What pricing strategy should be adopted for isosorbide mononitrate to remain competitive?

This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the isosorbide mononitrate industry.