Ranolazine (Ranexa) Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Ranolazine (Ranexa) 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 a ranolazine (ranexa) 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 ranolazine (ranexa) 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 ranolazine (ranexa) 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 ranolazine (ranexa) industry.

About Ranolazine (Ranexa)

Ranolazine (Ranexa) is a medication which belongs to the class of anti-anginal drugs and received FDA approval for the treatment of chronic angina pectoris in 2006. This heart medication is widely used to treat chronic cases of chest pain and ensures that there is no repetition of the acute pain episode. It is generally recommended to store this medication at room temperatures to ensure its effectiveness.

Properties of Ranolazine (Ranexa)

Ranolazine is a well-acclaimed derivative of piperazine, which is used to manage and control angina condition. Currently, this condition affects around 1.6 per cent of the world population . This medication exhibits antianginal and ischemic properties by blocking delayed rectifier potassium currents, thereby prolonging the QTc intervals. It does not exert any negative effect such as chronotropic, dromotropic, or inotropic, making it significantly effective.

Manufacturing Process of Ranolazine (Ranexa)

The synthesis of ranolazine (ranexa) is a fairly simple process. Firstly, the condensation of (piperazin-1-yl) acetamide is carried out with phenoxyoxirane in a boiling solvent mixture of toluene/methanol. Afterwards, the purification of the compound is performed in column chromatography. The purification process can also be performed by the conversion of crude product into fumaric acid salt or hydrochloride. This step is followed by the crystallisation of the salt and then basification to derive the desired compound of ranzoline (ranexa) for medicinal purposes.

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Synthesis of Ranolazine

The synthesis of ranolazine involves multiple steps starting from readily available starting materials.

Step 1: Preparation of 1-(2-Methoxyphenoxy)-2,3-epoxypropane

Chemicals Used: 2-Methoxyphenol (Guaiacol), Epichlorohydrin

Reaction: Guaiacol is reacted with epichlorohydrin under basic conditions to form 1-(2-methoxyphenoxy)-2,3-epoxypropane.

Chemical Equation: Chemical Equation: C7H8O2 + C3H5ClO → C10H12O3

Step 2: Ring Opening of Epoxide

Chemicals Used: Ammonia (NH3)

Reaction: The epoxide ring is opened by ammonia, forming an amino alcohol.

Chemical Equation: Chemical Equation: C10H12O3 + NH3 → C10H15NO3

Step 3: Formation of Nitrile

Chemicals Used: Diethyl sulfate (Et2SO4)

Reaction: The amino group is treated with diethyl sulfate to form a nitrile derivative.

Chemical Equation: Chemical Equation: C10H15NO3 + Et2SO4 → C10H14N2O3 + EtOH

Step 4: Hydrolysis of Nitrile to Amide

Chemicals Used: Water (H2O)

Reaction: The nitrile group is hydrolysed to form an amide.

Chemical Equation: Chemical Equation: C10H14N2O3 + H2O → C10H15NO4

Step 5: Methylation of Amide

Chemicals Used: Methyl iodide (CH3I)

Reaction: The amide nitrogen is methylated using methyl iodide.

Chemical Equation: Chemical Equation: C10H15NO4 + CH3I → C11H17NO4 + HI

Step 6: Final Cyclisation to Ranolazine

Chemicals Used: Heat or a suitable catalyst.

Reaction: The final step involves cyclisation of the methylated amide to form ranolazine.

Chemical Equation: Chemical Equation: C11H17NO4 → C15H21N2O2

Final structure of ranolazine is C15H21N2O2.

Applications and Drivers of Ranolazine (Ranexa)

Ranolazine, an effective medication for chest pain, disrupts the cardiac late sodium current (INa), potentially affecting the electrolyte balance in heart muscle tissues, thereby relieving angina symptoms. Angina refers to the pain in the chest due to the insufficient oxygen supply to the cardiac cells. There are approximately 30,000 to 40,000 cases of angina per million people in Western countries, which creates an urgent demand for ranolazine. It can be used alone or in combination with other medicines, depending upon the consultation of the doctor and instruction on prescription label.

Key Features of the Ranolazine (Ranexa) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the ranolazine (ranexa) 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 ranolazine (ranexa) 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 Ranolazine (Ranexa) production plant:

• Market Dynamics and Trends: This section analyses the prevailing market conditions, growth drivers, and trends impacting the ranolazine (ranexa) 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 ranolazine (ranexa) production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the ranolazine (ranexa) 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 ranolazine (ranexa) 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 ranolazine (ranexa), 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 ranolazine (ranexa) 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 and its development costs, 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 ranolazine (ranexa) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for ranolazine (ranexa) 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 ranolazine (ranexa) plant?

• How can profitability be maximised in the ranolazine (ranexa) market?

• What pricing strategy should be adopted for ranolazine (ranexa) to remain competitive?