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The Expert Market Research report, titled “Asenapine (Saphris) 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 asenapine (Saphris) plant.
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 asenapine (Saphris) 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 asenapine (Saphris) 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 asenapine (Saphris) industry.
Asenapine, sold under the brand name Saphris, is an atypical antipsychotic medication used to treat schizophrenia and acute mania associated with bipolar disorder. It was initially approved in the United States in 2009 and approved as a generic medication in 2020. Asenapine was chemically derived by altering the structure of the tetracyclic antidepressant mianserin. Common adverse effects of consuming this medicine include weight gain, extrapyramidal symptoms, sedation, and dizziness. Asenapine is taken sublingually as it is poorly absorbed orally.
Asenapine, sold under the brand name Saphris, is an atypical antipsychotic medication used to treat schizophrenia and bipolar disorder. It is available as a sublingual tablet, which allows for quick absorption and is beneficial for patients who have difficulty swallowing pills. Asenapine has a molar mass of 285.77 g/mol and the chemical formula C17H16ClNO. It is a white to off-white, round, fast-dissolving tablet.
The synthesis of asenapine maleate, the active pharmaceutical ingredient (API), begins with the combination of starting materials including 2-chloro-10,11-dihydro-5H-dibenz[b,e]azepine, and other necessary reagents. These compounds undergo a series of carefully controlled chemical reactions to produce the asenapine free base. The asenapine free base is then reacted with maleic acid to form the asenapine maleate API. After the API is synthesised, it undergoes formulation into the final sublingual tablet dosage form of Saphris. Finally, the Saphris tablets are packaged into the commercial containers, such as blister packs or bottles, and labelled for distribution.
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Below are the detailed steps involved in the synthesis of Asenapine:
Step 1: Synthesis of Key Intermediate
The synthesis of asenapine starts with the formation of a key intermediate, which involves the reaction of a suitable starting material such as 2-chlorobenzonitrile with appropriate reagents.
Chemical reaction: C7H4ClN + Reagents → Intermediate
Step 2: Cyclisation
The intermediate undergoes a cyclisation reaction to form the core structure of asenapine. This involves the formation of a new ring system.
Step 3: Functional Group Modification
The cyclised intermediate is then subjected to functional group modifications to introduce the required functional groups on the molecule.
Step 4: Final Product Formation
The modified intermediate undergoes final synthetic steps, including any necessary purification and crystallization, to produce asenapine.
Chemical reaction: Modified Intermediate + Reagents → Asenapine (C17H16ClNO)
Asenapine (Saphris) is an atypical antipsychotic medication used to treat schizophrenia and bipolar disorder in adults. It works by modulating certain neurotransmitters in the brain, such as dopamine and serotonin, to help manage symptoms like hallucinations, delusions, and mood swings. Saphris is approved by the FDA for acute monotherapy of manic or mixed episodes in adults and paediatric patients 10 to 17 years old with bipolar I disorder, as well as for adjunctive treatment to lithium or valproate in adults. The key drivers for the use of asenapine include its efficacy in reducing psychotic and manic symptoms, its relatively low risk of extrapyramidal side effects compared to older antipsychotics, and its availability in a sublingual formulation which can be beneficial for patients who have difficulty swallowing. However, it carries a black box warning for an increased risk of death in elderly patients with dementia-related psychosis and is not approved for this use.
This production cost analysis report by Expert Market Research scrutinises the asenapine (Saphris) 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 asenapine (Saphris) 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 asenapine (Saphris) production plant:
This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the asenapine (Saphris) industry.
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.
1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Research Methodology
3 Executive Summary
3.1 Market Trends
3.2 Raw Material Requirements
3.3 Income Projections
3.4 Expenditure Projections
3.5 Profit Analysis
4 Global Asenapine (Saphris) Market
4.1 Market Overview
4.2 Global Asenapine (Saphris) Historical Market (2018-2023)
4.3 Global Asenapine (Saphris) Market Forecast (2024-2032)
4.4 Global Asenapine (Saphris) Market Breakup by Segment
4.5 Global Asenapine (Saphris) Market Breakup by Region
4.6 Price Trends
4.6.1 Asenapine (Saphris) Price Trends
4.6.2 Product Margins
4.7 Competitive Landscape
4.7.1 Market Structure
4.7.2 Key Players
4.7.3 Profiles of Key Players
5 Asenapine (Saphris) Manufacturing Process
5.1 Product Overview
5.2 Detailed Process Flow
5.3 Various Types of Unit Operations Involved
5.4 Mass Balance and Raw Material Requirements
6 Production Cost Analysis
6.1 Raw Material Cost Analysis
6.1.1 Raw Material Suppliers
6.1.2 Price Trend of Raw Materials Required
6.1.3 Total Expense on Raw Materials
6.2 Utility Cost Analysis
6.2.1 Electricity Costs
6.2.2 Steam Costs
6.2.3 Process Water Costs
6.2.4 Total Expense on Utilities
6.3 Operating Cost Analysis
6.3.1 Salaries and Wages
6.3.2 Plant Overheads
6.3.3 Tax and Insurance
6.3.4 Packaging Costs
6.3.5 Transportation Costs
6.3.6 Sales and Administration Costs
6.3.7 Total Operating Costs
6.4 Capital Cost Analysis
6.4.1 Land and Site Development Costs
6.4.2 Civil Work Costs
6.4.3 Plant Machinery and Commissioning Costs
6.4.3.1 Plant Machinery Suppliers
6.4.3.2 Plant Machinery Costs
6.4.3.3 Auxiliary Equipment Cost
6.4.3.4 Electrical Works and Piping Costs
6.4.3.5 Other Fixed Costs
6.4.4 Working Capital Requirements for Plant Operation
6.4.5 Total Capital Investment Required
6.5 Total Production Cost
7 Loans and Financial Assistance
8 Project Economics
8.1 Capital Cost of the Project
8.2 Techno-Economic Parameters
8.3 Income Projections
8.4 Expenditure Projections
8.5 Product Pricing and Margins
8.6 Taxation
8.7 Depreciation
8.8 Financial Analysis
9 Regulatory Procedures and Approval
10 Key Success and Risk Factors
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