Alogliptin (Nesina) Manufacturing Plant Project Report 2024

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 alogliptin (nesina) 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 an alogliptin (nesina) 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 alogliptin (nesina) industry.

About Alogliptin (Nesina)

Alogliptin is a medication used to treat type 2 diabetes. It functions by inhibiting an enzyme known as DPP-4, which in turn enhances the levels of incretins (metabolic hormones), which play a crucial role in lowering blood sugar levels. Primarily, it boosts insulin levels in the body, reduces blood sugar (glucose) levels, and mitigates the sugar release in the bloodstream. Typically, the doctor recommends this medication along with some changes in diet and exercise.

Properties of Alogliptin (Nesina)

Alogliptin possesses a molecular weight of 339.4 g/mol and is found in the form of white to off-white crystalline powder. This medication is generally stored at room temperature between 20 and 25 degrees C (68- and 77 degrees F) to preserve its medicinal qualities. It is also chemically formulated as a benzoate salt and is primarily present as the R-enantiomer (>99%). Moreover, it possesses a terminal half-life of 21 hours and a water solubility of 0.58 mg/ml as it is sparingly soluble in water.

Manufacturing Process of Alogliptin (Nesina)

The production process of alogliptin comprises 3 primary steps. Firstly, the 6-chlorouracil is made to react with a-bromo-o-tolunitrile in the presence of strong alkali like sodium hydride (NaH) and lithium bromide (LiBr) in a solvent mixture of dimethylformamide (DMF) and dimethylsulfoxide (DMSO) to produce the 2-(6-chloro-2,4-dioxo-3,4-dihydro-2H-pyrimidin-l-ylmethyl) benzonitrile, an intermediate compound. Secondly, this intermediate compound undergoes methylation using methyl iodide (MeI) with sodium hydride in a solvent mixture of dimethylformamide (DMF) and tetrahydrofuran (THF) to obtain the 2-[(6-chloro-3-methyl-2,4-dioxo-3,4-dihydro-2H-pyrimidin-l-yl) methyl] benzonitrile, an N-methylated compound. Finally, the N-methylated intermediate compound is made to react with (R)-3-amino-piperidine dihydrochloride in the presence of sodium bicarbonate and a solvent such as methanol to yield alogliptin-free base, the active form of alogliptin.

Read more about this report - REQUEST FREE SAMPLE COPY IN PDF

Synthesis of Alogliptin (Nesina)

Step 1: Synthesis of Cyanopyrrolidine Intermediate

Chemicals: Pyrrolidine, Acrylonitrile

Reaction: Pyrrolidine (C4H9N) + Acrylonitrile (CH2) = CH-CN → Cyanopyrrolidine (C6H10N2)

Step 2: Formation of Aminopyrazine Intermediate

Chemicals: Aminopyrazine

Reaction: Nucleophilic substitution on an aminopyrazine precursor.

Step 3: Coupling of Cyanopyrrolidine and Aminopyrazine

Chemicals: Cyanopyrrolidine from Step 1, Aminopyrazine derivative from Step 2

Reaction: Cyanopyrrolidine (C6H10N2) + Aminopyrazine derivative → Alogliptin precursor

Step 4: Final Modifications

Chemicals: Alogliptin precursor, Various reagents for final modification

Reaction: Final modifications such as methylation or the removal of protecting groups.

Step 5: Purification

Process: The crude Alogliptin is purified using chromatographic techniques.

Final Product: Alogliptin (Nesina)

Chemical Formula: C18H21N5O2

Applications and Drivers of Alogliptin (Nesina)

Alogliptin is used for the treatment of type-2 diabetes, and it works by increasing the levels of incretin hormones in the body, helping to regulate blood sugar levels. It is often recommended as an additional treatment along with diet and exercise to improve glycaemic control in adults suffering from this condition. Alogliptin can also be used on its own if diet and exercise do not help in managing blood sugar levels. Furthermore, it is commonly prescribed with other antidiabetic medications such as metformin, sulfonylureas, or insulin for effective treatment.

Key Features of the Alogliptin (Nesina) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the alogliptin (nesina) 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 alogliptin (nesina) 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 an alogliptin (nesina) production plant:

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

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

Key Questions Addressed:

• What are the detailed unit operations for alogliptin (nesina) 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 alogliptin (nesina) plant?

• How can profitability be maximised in the alogliptin (nesina) market?

• What pricing strategy should be adopted for alogliptin (nesina) to remain competitive?

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