Diclofenac (Voltaren) Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Diclofenac (Voltaren) 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 diclofenac (voltaren) 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 diclofenac (voltaren) 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 diclofenac (voltaren) 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 diclofenac (voltaren) industry.

About Diclofenac (Voltaren)

Diclofenac (Voltaren) is a type of anti-inflammatory drug which is used for the treatment of joint pain. It can reduce the inflammation caused by arthritis, a condition in which swelling occurs in one or more than one joints. Diclofenac is also used as a first line of therapy for acute pain conditions and was approved by the FDA in July 1988 under the brand name Voltaren.

Properties of Diclofenac (Voltaren)

Diclofenac (Voltaren), which belongs to a group of medications known as NSAIDs, is a derivative of phenylacetic acid and has a chemical name 2-[(2,6-chlorophenyl) amino] benzene- acetic acid, monosodium salt. This compound possesses a terminal half-life of 2 hours and a water solubility of 0.00447 mg/mL. It contains an active substance, diclofenac sodium which appears in crystalline powder form and depicts a white to slightly yellow colour.

Manufacturing Process of Diclofenac (Voltaren)

The production process of diclofenac is a multi-step process that results in the formation of diclofenac sodium salt. Firstly, a reaction occurs between 2,6-Dichloroaniline and 1-chloro-2-nitrobenzene in the presence of copper as a catalyst. In the next step, catalytic hydrogenation takes place for the conversion of the nitro group to the amine group. The carboxylic acid derivative of diclofenac is first formed which is then neutralised to obtain diclofenac sodium salt. The diclofenac can be then extracted and purified for industrial purposes.

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Synthesis of Diclofenac (Voltaren)

Diclofenac, commonly known by its brand name Voltaren, is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The synthesis of diclofenac involves several steps, starting from 2,6-dichloroaniline and finishing with the formation of the final diclofenac sodium salt. Here are the primary steps:

1.    Synthesis of 2,6-dichlorodiphenylamine:

Reactants: 2,6-Dichloroaniline (C6H3Cl2NH2) and 1-Chloro-2-nitrobenzene (C6H4ClNO2).

Reaction: C6H3Cl2NH2 + C6H4ClNO2 → C12H8Cl3N + H2O.

Conditions: This reaction is carried out in the presence of a base and a copper catalyst at elevated temperatures.

2.    Reduction of the Nitro Group:

Reactants: 2,6-Dichlorodiphenylamine (C12H8Cl3N)

Reaction: C12H8Cl3N + 3H2 → C12H10Cl3N

Conditions: The nitro group is reduced to an amine group using catalytic hydrogenation.

3.    Formation of Diclofenac:

Reactants: 2-(2,6-Dichloroanilino) phenylacetic acid.

Reaction: C14H11Cl2NO2 → Diclofenac (C14H11Cl2NO2)

Conditions: This step involves the formation of the carboxylic acid derivative.

4.    Conversion to Diclofenac Sodium:

Reactants: Diclofenac (C14H11Cl2NO2) and Sodium Hydroxide (NaOH)

Reaction: C14H11Cl2NO2 + NaOH → Diclofenac Sodium (C14H10Cl2NO2Na) + H2O

Conditions: Neutralisation reaction to form the sodium salt of diclofenac.

5.    Final Reaction:

C6H3Cl2NH2 + C6H4ClNO2 + 3H2 + NaOH → Diclofenac Sodium (C14H10Cl2NO2Na) + H2O

This multi-step synthesis showcases how diclofenac is manufactured in organic pharmaceutical sector.

Applications and Drivers of Diclofenac (Voltaren)

Diclofenac is widely used for the treatment of both chronic and acute episodes as it inhibits the growth of cyclooxygenase (COX)-1 and-2, pain-inducing enzymes. It can further be used for the treatment of ankylosing spondylitis, an inflammatory condition which affects the spine and large joints of a person. This medication may also be used to mitigate the inflammation caused by physical trauma and surgery. Around 1 billion people are estimated to suffer from arthritis by 2050, which creates a rapid rise in demand for diclofenac.

Key Features of the Diclofenac (Voltaren) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the diclofenac (voltaren) 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 diclofenac (voltaren) 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 diclofenac (voltaren) production plant:

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

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

Key Questions Addressed:

• What are the detailed unit operations for diclofenac (voltaren) 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 diclofenac (voltaren) plant?

• How can profitability be maximised in the diclofenac (voltaren) market?

• What pricing strategy should be adopted for diclofenac (voltaren) to remain competitive?

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