Alogliptin Manufacturing Plant Project Report: Key Insights and Outline

Alogliptin Manufacturing Plant Project Report thoroughly focuses on every detail that encompasses the cost of manufacturing. Our extensive cost model meticulously covers breaking down expenses around raw materials, labour, technology, and manufacturing expenses. This enables precise cost structure optimization and helps in identifying effective strategies to reduce the overall cash cost of manufacturing.

Alogliptin is an oral antidiabetic medication that is used to manage type 2 diabetes mellitus. It is used to help lower blood sugar levels in adults with type 2 diabetes when only diet and exercise are insufficient. It works by stopping the DPP-4 enzyme that increases the release of insulin from the pancreas and decreases the hormones that raise blood sugar. It helps in maintaining better control of both fasting and post-meal glucose levels. It is also used in combination with other diabetes medications like metformin or pioglitazone. It improves glycemic control without causing significant weight gain or a high risk of hypoglycemia. This helps reduce the risk of long-term diabetes complications like heart disease, kidney problems, nerve damage, and eye issues by maintaining stable blood sugar levels.
 

Top 5 Manufacturers of Alogliptin

• Takeda Pharmaceutical Company Limited
• Perrigo Company plc
• Hikma Pharmaceuticals
• Furiex Pharmaceuticals
• Allergan plc
   

Feedstock for Alogliptin

The production of Alogliptin uses 6-Chloro-3-Methyluracil and 2-(Bromomethyl) Benzonitrile as the major feedstock. The changes in the market dynamics of these raw materials affect the manufacturing of Alogliptin.

The procurement of 6-Chloro-3-Methyluracil is driven by factors like raw materials costs and availability, market demand, regulatory and quality standards, safety measures, and environmental controls etc. The costs and availability of its raw materials, like methylbarbituric acid (the supplier availability and regional production capacity affect methylbarbituric acid sourcing), chlorinating agents (strict regulations for purchase, transport, and storage of chlorinating agents complicate its procurement), impact its production costs.

The fluctuations in its demand in downstream applications like agrochemicals, coordination chemistry, antibacterial agents, and research chemicals for biological and material sciences affect its availability. It requires to be handled with PPE in well-ventilated areas, stored in tightly sealed containers, and disposed of according to local environmental regulations. Regulatory compliance includes minimizing occupational exposure and preventing release into waterways, which adds to its procurement costs.

2-(Bromomethyl) Benzonitrile is another major feedstock used in the manufacturing of Alogliptin. Its sourcing is affected by prices and availability of its major raw material, like 2-bromobenzyl alcohol (compliance with strict environmental and regulatory requirements related to the production and handling of brominated compounds affects its procurement). The changes in its demand as an intermediate in the pharmaceutical industry and in the production of heterocycles and chiral standards impact its availability.  Safety and handling requirements, because of its tear-inducing properties, require adherence to proper protocols and safety measures that add to its procurement costs.
 

Market Drivers for Alogliptin

The market for Alogliptin is driven by its clinical uses and therapeutic benefits in managing type 2 diabetes. Its utilization for lowering blood sugar levels in adults makes it a useful option for monotherapy. Its usage as an add-on with other antidiabetic agents like metformin or pioglitazone contributes to its market. Its ability to be combined with other oral hypoglycemic drugs or insulin makes it a flexible drug in treatment regimens for different patients, which boosts its demand. Its efficiency for improving HbA1c and fasting plasma glucose further expands its clinical demand.

In the North American region, high rates of type 2 diabetes and advanced healthcare systems drive strong demand for Alogliptin. The European market is fueled by an aging population, increasing diabetes cases, and supportive regulatory frameworks that encourage the adoption of innovative treatments. The Asia-Pacific region is growing because of rapid urbanization, lifestyle changes, and a surge in diabetes cases in populous countries, along with improving healthcare access and rising health awareness.

The CAPEX for Alogliptin manufacturing plant involves costs of stainless-steel raw material tanks, glass-lined reactors, overhead condensers, temperature-controlled jackets, and an agitated nutsche filter dryer (ANFD). It also includes jacketed crystallizers, rotary cone vacuum dryers (RCVDs) or vacuum tray dryers (VTDs), a solvent recovery unit (SRU), and a distillation column with reboiler and reflux condenser. Utility systems include a steam boiler, cooling tower, chiller, compressed air system, nitrogen generator, and PLC/DCS-based automation system also comes under CAPEX.

Its OPEX includes the cost of high-purity raw materials and utility costs coming from the usage of steam, electricity, chilled water, and compressed air. The wages for skilled labor to operate and maintain the batch reactors, separation units, distillation columns, and analytical instruments are covered under OPEX. It also includes quality assurance, regulatory documentation, cleanroom maintenance, and GMP validation processes, along with proper waste management systems.
 

Manufacturing Process

This report comprises a thorough value chain evaluation for Alogliptin manufacturing and consists of an in-depth production cost analysis revolving around industrial Alogliptin manufacturing.

• From 6-Chloro-3-Methyluracil and 2-(Bromomethyl)Benzonitrile: The feedstock for this process includes 6-chloro-3-methyluracil and 2-(bromomethyl)benzonitrile.

The manufacturing process of Alogliptin involves two main steps. First, 6-chloro-3-methyluracil reacts with 2-(bromomethyl)benzonitrile in the presence of a solvent like toluene to form 2-[(6-chloro-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl]benzonitrile as an intermediate. After that, this intermediate is reacted with 3-aminopiperidine in the presence of a base like sodium bicarbonate and an organic solvent like n-butanol, and results in the formation of Alogliptin as the final product.
 

Properties of Alogliptin

Alogliptin has a molecular formula of C18H21N5O2 and a molecular weight of 339.39 g/mol. It is a white to off-white solid that has a melting point of 127–129 degree Celsius.  It is barely soluble in water, but slightly soluble in solvents like chloroform, ethyl acetate, and methanol. It has a partition coefficient (logP) of 0.66, which makes it moderately lipophilic. It has an aqueous solubility (logS) of -2.8, and it exists as the R-enantiomer. It contains a piperidine ring, a uracil core, and a cyanobenzyl group, which are key to its selective inhibition of the DPP-4 enzyme. Its pKa value is around 9.89, and it has a topological polar surface area of about 94 Å. It is stable under normal conditions, non-flammable, and does not present an explosion hazard.

Alogliptin Manufacturing Plant Report provides you with a detailed assessment of capital investment costs (CAPEX) and operational expenses (OPEX), generally measured as cost per metric ton (USD/MT). This approach ensures that your investment decisions are aligned with the latest industry standards and economic feasibility metrics, enhancing your manufacturing efficiency and financial planning.

Apart from that, this Alogliptin manufacturing plant report also covers the leading technology providers that help you plan a robust plan of action related to Alogliptin manufacturing plant and its production process(es), and also by helping you with an in-depth supplier database. This report provides exclusive insights into the best manufacturing practices for Alogliptin and technology implementation costs. This report also covers operational cash flow, fixed and variable costs, and detailed break-even point analysis, ensuring that your manufacturing process is not only efficient but also economically viable in the competitive market landscape.

In addition to operational insights, the Alogliptin manufacturing plant report also comprehensively focuses on lifecycle cost analysis, maintenance costs, and energy consumption costs, which are critical for maintaining long-term sustainability and profitability. Our manufacturing cost analysis extends to include regulatory compliance costs, inventory holding costs, and logistics and distribution costs, providing a holistic view of the potential expenses and savings.

We at Procurement Resource ensure that this report is not only cost-efficient, environmentally sustainable, and aligned with the latest technological advancements but also that you are equipped with all necessary tools to optimize supply chain operations, manage risks effectively, and achieve superior market positioning for Alogliptin.
 

Key Insights and Report Highlights

Key Questions Covered in our Alogliptin Manufacturing Plant Report

• How can the cost of producing Alogliptin be minimized, cash costs reduced, and manufacturing expenses managed efficiently to maximize overall efficiency?
• What are the initial investment and capital expenditure requirements for setting up an Alogliptin manufacturing plant, and how do these investments affect economic feasibility and ROI?
• How do we select and integrate technology providers to optimize the production process of Alogliptin, and what are the associated implementation costs?
• How can operational cash flow be managed, and what strategies are recommended to balance fixed and variable costs during the operational phase of Alogliptin manufacturing?
• How do market price fluctuations impact the profitability and cost per metric ton (USD/MT) for Alogliptin, and what pricing strategy adjustments are necessary?
• What are the lifecycle costs and break-even points for Alogliptin manufacturing, and which production efficiency metrics are critical for success?
• What strategies are in place to optimize the supply chain and manage inventory, ensuring regulatory compliance and minimizing energy consumption costs?
• How can labor efficiency be optimized, and what measures are in place to enhance quality control and minimize material waste?
• What are the logistics and distribution costs, what financial and environmental risks are associated with entering new markets, and how can these be mitigated?
• What are the costs and benefits associated with technology upgrades, modernization, and protecting intellectual property in Alogliptin manufacturing?
• What types of insurance are required, and what are the comprehensive risk mitigation costs for Alogliptin manufacturing?