Apixaban (Eliquis) 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 apixaban (Eliquis) 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 apixaban (Eliquis) 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 apixaban (Eliquis) industry.

About Apixaban (Eliquis)

Apixaban (Eliquis) is an anticoagulant medication used to treat and prevent blood clots, reduce the risk of stroke in people with atrial fibrillation, and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) after hip or knee replacement surgery. It directly inhibits factor Xa, making blood less likely to clot. Apixaban was approved for medical use in the European Union in May 2011 and in the United States in December 2012 for the prevention of stroke in people with atrial fibrillation. It was later approved for additional indications in 2014.

Properties of Apixaban (Eliquis)

Apixaban is an oral direct and is a white to pale-yellow powder with a molecular weight of 459.5. At physiological pH (1.2-6.8), it does not ionise and has an aqueous solubility of ~0.04 mg/mL. It selectively inhibits free and bound FXa, as well as prothrombinase activity, independent of antithrombin III. Also, apixaban indirectly inhibits platelet aggregation induced by thrombin.

Manufacturing Process of Apixaban (Eliquis)

The production process of Apixaban (Eliquis) begins with the synthesis of Apixaban through a multi-step process. Next, the API is blended with excipients, such as lactose and microcrystalline cellulose. The mixture undergoes wet granulation to form granules. The granules are then again blended and compressed into tablets, which are subsequently coated with a film for stability and aesthetic appeal. Finally, the tablets are packaged for distribution, completing the manufacturing process. This systematic approach guarantees controlled dosage and bioavailability of Apixaban.

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Synthesis of Apixaban (Eliquis)

Below is a step-by-step outline of the process to produce Apixaban:

Step 1: Synthesis of Intermediate A (4-Methoxy-N-(2-oxo-1-phenyl-2,3-dihydro-1H-pyrrolo[3,4-b]quinolin-3-yl)benzamide)

Reaction 1: Formation of Intermediate 1

Starting Materials:

• 2-Chloro-N-(4-methoxyphenyl)acetamide (C9H10ClNO2)

• Sodium hydride (NaH)

• 2-Chloroquinoline (C9H6ClN)

Reaction:

C9H10ClNO2 + NaH + C9H6ClN → C18H14Cl2N2O2 + NaCl + H2

Product: 2-(4-Methoxyphenyl)-2-oxoethyl 2-chloroquinoline-4-carboxylate (Intermediate 1)

Reaction 2: Cyclisation to Intermediate 2

Starting Materials:

• Intermediate 1 (C18H14Cl2N2O2)

• Base (e.g., Potassium carbonate, K2CO3)

Reaction:

C18H14Cl2N2O2 + K2CO3 → C19H15ClN2O3 + KCl + CO2

Product: 4-Methoxy-N-(2-oxo-1-phenyl-2,3-dihydro-1H-pyrrolo[3,4-b]quinolin-3-yl)benzamide (Intermediate 2)

Step 2: Synthesis of Apixaban

Reaction 3: Coupling Reaction

Starting Materials:

• Intermediate 2 (C19H15ClN2O3)

• Piperidine (C5H11N)

• Reducing agent (e.g., Sodium borohydride, NaBH4)

Reaction:

C19H15ClN2O3 + C5H11N + NaBH4 → C25H25N5O4 + NaCl + H2O

Product: Apixaban (C25H25N5O4)

Applications and Drivers of Apixaban (Eliquis)

Apixaban, marketed as Eliquis, is an oral anticoagulant that is primarily used for preventing blood clot formation. Its main applications include the prevention and treatment of deep vein thrombosis and pulmonary embolism, particularly in patients undergoing hip or knee replacement surgeries, as well as in individuals with atrial fibrillation. Additionally, apixaban is favoured for its predictable pharmacokinetics, which eliminate the need for routine monitoring of anticoagulation levels, making it a convenient choice for patients and healthcare providers.

Key Features of the Apixaban (Eliquis) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the apixaban (Eliquis) 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 apixaban (Eliquis) 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 apixaban (Eliquis) production plant:

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

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

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

Key Questions Addressed:

• What are the detailed unit operations for apixaban (Eliquis) 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 apixaban (Eliquis) plant?

• How can profitability be maximised in the apixaban (Eliquis) market?

• What pricing strategy should be adopted for apixaban (Eliquis) to remain competitive?

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