Sulfinpyrazone Manufacturing Plant Project Report 2025: Market by Region, Market by Application, Key Players, Pre-feasibility, Capital Investment Costs, Production Cost Analysis, Expenditure Projections, Return on Investment (ROI), Economic Feasibility, CAPEX, OPEX, Plant Machinery Cost

Sulfinpyrazone Manufacturing Plant Project Report 2025: Cost Analysis, ROI, and Feasibility Insights

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

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Sulfinpyrazone is a pharmaceutical active ingredient, which is categorised as a uricosuric agent and a platelet aggregation inhibitor. It appears in the form of a white to off-white crystalline powder. It is mainly used in the management of chronic gout (gouty arthritis) by reducing elevated uric acid levels in the blood by enhancing the excretion of uric acid by the kidneys. Sulfinpyrazone is also used to prevent or treat conditions linked with high uric acid in the body.
 

Top Manufacturers of Sulfinpyrazone

• Medivis
• Incepta
• TTY Biopharm
• AA Pharma
• American Taiwan Biopharm (ATB)
• Merck KGaA (Germany)
   

Applications of Sulfinpyrazone

Sulfinpyrazone is a highly valuable medication used for treating specific conditions related to high uric acid around the world.

• Treatment of Chronic Gout and Hyperuricemia:
  • Uric Acid Reduction: Sulfinpyrazone is primarily used as a uricosuric agent for reducing uric acid in the body. It helps in the inhibition of the reabsorption of uric acid in the renal tubules, leading to increased excretion of uric acid in the urine. This action effectively lowers high serum urate levels, which are the underlying cause of chronic gout and can lead to gouty arthritis.
  • Gout Attack Prevention: It also helps prevent the recurrence of gout attacks over time, reducing the frequency and severity of painful episodes for patients suffering from chronic gout. It is often prescribed for long-term management once an acute attack has subsided.
  • Prevention of Uric Acid Complications: It can also be used to prevent or manage other medical problems associated with elevated uric acid levels, such as kidney stones composed of uric acid.
• Antithrombotic / Platelet Inhibitory Effects:
  • Prevention of Blood Clots: Sulfinpyrazone possesses antithrombotic properties, meaning it can help prevent the formation of blood clots. It achieves this by inhibiting platelet aggregation, reducing the stickiness of platelets, and preventing them from clumping together to form thrombi.
  • Cardiovascular Applications (Historical/Niche): Historically, it was sometimes used in the prevention of thromboembolic events, such as those following myocardial infarction or in conditions prone to clot formation. While newer antiplatelet agents are now more common, their use in specific niches for this purpose may still exist.
     

Feedstock for Sulfinpyrazone Production

The main feedstock materials for Sulfinpyrazone manufacturing are hydrazobenzol and 2-(2-phenylthioethyl)malonic ester. The industrial procurement of these specialised raw materials and the dynamics affecting their global supply are crucial for the overall production cost analysis and value chain evaluation for pharmaceutical manufacturers.

• Hydrazobenzol (1,2-Diphenylhydrazine):
  • Production Route: Hydrazobenzol is synthesised through the reduction of nitrobenzene. Common industrial methods involve the catalytic hydrogenation of nitrobenzene or reduction using agents like zinc or iron in alkaline conditions.
  • Supply Dynamics: The supply of hydrazobenzol is tied to the availability and cost of its precursor, nitrobenzene, which is a large-volume industrial chemical derived from benzene. Environmental regulations regarding nitrobenzene handling and its reduction processes can influence production costs.
  • Purity Requirements: High purity of hydrazobenzol is important for pharmaceutical synthesis to minimise impurities in the final API, adding complexity and cost to its industrial procurement. Manufacturers often need to source from specialised fine chemical producers.
  • Safety Considerations: Hydrazobenzol can be a hazardous substance, and its handling, storage, and transportation require stringent safety protocols, contributing to the manufacturing expenses.
• 2-(2-phenylthioethyl)malonic ester:
  • Production Route: This is a more complex, specialised chemical intermediate. Its synthesis would typically involve a multi-step organic chemistry route. This likely involves the malonic ester synthesis, where a malonic ester (e.g., diethyl malonate) is alkylated with an appropriate halide containing the 2-phenylthioethyl group. The phenylthioethyl group itself would be synthesised from benzene/thiophenol and an ethylating agent.
  • Supply Dynamics: As a niche chemical intermediate, its supply is often limited to specialised fine chemical or custom synthesis manufacturers. Production is typically on a smaller scale compared to commodity chemicals.
  • Price Volatility: Its price is highly dependent on the cost of its precursors (diethyl malonate, benzene derivatives, sulfur compounds) and the complexity of its multi-step synthesis. Limited suppliers can also lead to higher prices.
  • Synthesis Complexity: The multi-step nature of its synthesis requires specialised equipment, skilled labour, and rigorous quality control, directly impacting its cost model as a raw material.
     

Market Drivers for Sulfinpyrazone

The market for Sulfinpyrazone is mainly driven by its demand as a treatment for gout and hyperuricemia, helping manage uric acid levels in the body.

• Rising Incidence and Prevalence of Gout:
  • Lifestyle Factors: The global increase in sedentary lifestyles, obesity, and diets rich in purines contributes to a rising prevalence of hyperuricemia and gout. This trend increases the long-term demand for uricosuric agents like Sulfinpyrazone.
  • Ageing Population: As the global population ages, the incidence of chronic diseases like gout, which often manifests in older adults, tends to increase, creating a consistent patient pool.
  • Awareness and Diagnosis: Improved diagnostic capabilities and greater awareness among healthcare professionals lead to more identified cases of gout, increasing the number of patients requiring treatment.
• Need for Long-Term Uric Acid Management:
  • Preventive Therapy: Sulfinpyrazone's role in preventing recurrent gout attacks underscores the ongoing need for long-term management of hyperuricemia, rather than just treating acute flare-ups. This drives continuous prescription volumes.
  • Treatment Guidelines: Global clinical guidelines for gout often recommend uricosuric agents for patients who cannot tolerate or do not respond adequately to other uric acid-lowering therapies (e.g., xanthine oxidase inhibitors).
• Specific Niche in Gout Therapy:
  • Alternative to First-Line Drugs: It is not always a first-line therapy, but it remains an important option for patients who may have contraindications or adverse reactions to more commonly prescribed drugs like allopurinol or febuxostat. It is used for those requiring additional uric acid lowering.
  • Complementary Therapy: It can be used in combination with other anti-gout medications, further solidifying its role in comprehensive gout management.
• Antithrombotic Properties (Niche/Historical):
  • Legacy Use: Sulfinpyrazone's historical use and established efficacy in certain antithrombotic scenarios provide a limited market, particularly where specific patient profiles or historical prescribing habits exist.
  • Research Interest: Ongoing research into broader applications of uricosuric or platelet-inhibiting compounds could potentially uncover new uses, although this is a long-term speculative driver.
• Global Healthcare Expenditure:
  • Access to Healthcare: Increasing healthcare expenditure and expanding access to medical treatment in emerging geo-locations contribute to a broader patient base for chronic conditions like gout.
     

CAPEX and OPEX for Sulfinpyrazone Manufacturing

Operating expenses (OPEX) and total capital expenditure (CAPEX) must be thoroughly examined in order to provide a thorough production cost analysis for a sulfinpyrazone plant. The Sulfinpyrazone manufacturing plant cost is a primary determinant of the overall investment cost for an Active Pharmaceutical Ingredient (API) manufacturing facility.
 

Capital Expenditure (CAPEX):

The Sulfinpyrazon manufacturing plant capital cost covers investment for establishing and equipping its manufacturing plant.

• Land and Site Development: Acquisition of suitable industrial land within a pharmaceutical or chemical industrial zone, followed by comprehensive site grading, foundation work, and initial environmental impact assessments. Compliance with pharmaceutical industry zoning and infrastructure requirements is critical.
• Civil and Building Construction: Construction of specialised cleanroom facilities, reaction bays, purification areas, drying rooms, raw material storage (including controlled environments for sensitive materials), finished API warehouses, a dedicated analytical quality control laboratory, and administrative offices. Buildings must meet Good Manufacturing Practice (GMP) standards.
• Reactors/Reaction Vessels: Stainless steel or glass-lined reactors capable of handling the condensation and oxidation reactions. These vessels must be equipped with precise temperature control (heating/cooling jackets), agitation systems, and inert atmosphere capabilities (e.g., nitrogen blanketing) for safety and yield optimisation.
• Filtration Equipment: Pressure filters, centrifuges, or nutsche filters for separating the solid intermediate (pyrazolidinedione) and the final Sulfinpyrazone product from liquid mother liquors. These must be suitable for pharmaceutical-grade solids.
• Oxidation Reactors: Specific vessels for the oxidation step using hydrogen peroxide in acetic acid, requiring materials of construction compatible with oxidisers and acids.
• Crystallisation Equipment: Crystallisers for controlled cooling or solvent evaporation to achieve the desired particle size and polymorphic form of Sulfinpyrazone, crucial for downstream processing and bioavailability.
• Drying Equipment: Vacuum dryers, tray dryers, or fluid bed dryers designed for pharmaceutical products, ensuring efficient removal of solvent residues and moisture while preventing degradation.
• Solvent Recovery Systems: Distillation columns and condensers for recovering solvents (e.g., acetic acid, reaction solvents) used in the process, crucial for both cost efficiency and environmental compliance.
• Material Handling Systems: Enclosed conveying systems for solids, metering pumps for liquids, and controlled charging systems for raw materials into reactors, adhering to contamination control principles.
• Utilities Infrastructure: Installation of high-purity water generation systems (demineralised, purified water), industrial boilers for steam, chillers for cooling, compressed air (instrument air, plant air), and a robust electrical power distribution network with backup systems to ensure uninterrupted operation.
• Instrumentation and Control Systems: State-of-the-art Distributed Control Systems (DCS) or Programmable Logic Controllers (PLC) for precise monitoring and automated control of all process parameters (temperature, pressure, pH, stirring speed, reactant addition rates), ensuring batch consistency and regulatory compliance.
• Quality Control (QC) Laboratory: Extensive analytical equipment including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier-Transform Infrared (FTIR) spectroscopy, UV-Vis spectrophotometers, Karl Fischer titrators, and dissolution testers for raw material, in-process, and finished product testing.
• Safety and Environmental Systems: Comprehensive safety measures, including fume hoods, emergency showers/eyewash stations, fire detection and suppression systems, solvent vapour recovery, and advanced wastewater treatment facilities for chemical effluents. Compliance with local and international pharmaceutical and environmental regulations is paramount.
• Packaging and Storage: Equipment for packaging the final API into appropriate containers (e.g., drums, bags) under controlled conditions, and temperature-controlled storage facilities.
• Engineering, Procurement, and Construction (EPC) Costs: Fees for detailed engineering design (specialised for API manufacturing), procurement of specialised and often imported equipment, and the safe and compliant construction management of the entire facility, adhering to global GMP standards (e.g., US FDA, EMA, WHO GMP).
   

Operating Expenses (OPEX):

Operating expenses consist of both fixed and variable costs. It mainly covers the expenses involved in buying raw materials, labour costs, energy costs, and maintenance and repair charges.

• Raw Material Costs: It covers the costs of purchasing hydrazobenzol, 2-(2-phenylthioethyl)malonic ester, hydrogen peroxide, acetic acid, and other solvents, catalysts, and reagents. Given the specialised nature of some inputs, industrial procurement involves managing supply chain complexities and potential price volatility.
• Utility Costs:
  • Energy/Fuel: Significant expenses for heating reactors, running distillation columns, and operating dryers.
  • Electricity: For powering all machinery, pumps, cooling systems, and analytical equipment.
  • Water: For process use (purified water), cooling, and cleaning, with associated treatment costs.
• Labour Costs: Wages, benefits, and ongoing specialised training for highly skilled chemists, chemical engineers, operators, quality control analysts, and safety personnel. Compliance with GMP requires a highly trained workforce.
• Maintenance and Repair: Routine preventative maintenance and unexpected equipment repairs for specialised reactors, filtration units, and drying equipment. Maintaining the integrity of corrosion-resistant and cleanroom-grade equipment is critical.
• Catalyst and Reagent Costs: Expense associated with initial catalyst loading, periodic replacement, and the consumption of various reagents (e.g., hydrogen peroxide, acetic acid).
• Consumables: Includes filters, laboratory chemicals, chromatography columns, and other analytical consumables.
• Waste Treatment and Disposal: Significant costs associated with the safe collection, treatment, and disposal of chemical waste, including solvents and process residues, in strict compliance with environmental regulations.
• Packaging Costs: Costs for specialised, pharmaceutical-grade packaging materials for the API.
• Logistics and Transportation: Inbound freight costs for raw materials from global sources and outbound freight costs for the finished API to drug formulators worldwide.
• Quality Control and Assurance Costs: Ongoing expenses for analytical testing, validation studies, stability testing, and maintaining a robust Quality Management System (QMS) as per GMP requirements.
• Regulatory Compliance Costs: Significant ongoing costs for maintaining regulatory approvals, conducting audits, and adhering to evolving pharmaceutical regulations globally.
• Depreciation and Amortisation: Non-cash expenses that are crucial for calculating the economic feasibility of the manufacturing plant.
• Administrative and Overhead Costs: Salaries for general office expenses, administrative staff, insurance (including liability insurance for pharmaceutical products), and research and development (R&D) expenses for process optimisation or new product development.

All the manufacturing expenses help in determining the cost per metric ton (USD/MT) of Sulfinpyrazone, which provides insight into its overall economic feasibility.
 

Manufacturing Process

This report includes a thorough value chain evaluation for Sulfinpyrazone manufacturing and provides an in-depth production cost analysis revolving around industrial Sulfinpyrazone manufacturing.

• Production from Hydrazobenzol: The manufacturing process of Sulfinpyrazone starts with a condensation reaction between hydrazobenzol and 2-(2-phenylthioethyl)malonic ester, which is carefully controlled. The reaction forms an intermediate compound called pyrazolidinedione, which has a key ring structure. After this, the pyrazolidinedione compound undergoes oxidation. In this step, it is treated with hydrogen peroxide in an acetic acid solvent, turning the sulfide group into a sulfoxide. This transformation results in the formation of Sulfinpyrazone as the active pharmaceutical ingredient. Finally, the product is purified through crystallisation, filtration, and drying to ensure it’s ready for use.
   

Properties of Sulfinpyrazone

Sulfinpyrazone is a derivative of phenylbutazone. It possesses specific physical and chemical characteristics and is known for its pharmaceutical uses. It appears as a white to off-white crystalline powder.
 

Physical Properties:

• Molecular Formula: C23H20N2O3S
• Molar Mass: 404.48 g/mol
• Melting Point: 136-137 degree Celsius
• Boiling Point: It decomposes before boiling at high temperatures.
• Density: No readily available specific gravity for the solid form, as it is a pharmaceutical compound.
• Flash Point: Not applicable (as it is a solid pharmaceutical compound)
   

Chemical Properties:

• Solubility: It is slightly soluble in water, but readily soluble in organic solvents such as ethyl acetate, chloroform, acetone, and dilute alkaline solutions. It is also slightly soluble in alcohol and ether.
• Stability: It is stable to light and air under recommended storage conditions. It can undergo both reduction and oxidation under certain conditions.
• Acidity: Possesses weakly acidic properties due to the hydrogen at the 4-position of the pyrazolidinedione ring, which contributes to its pharmacological activity.
• Structure: It is a sulfoxide and a member of the pyrazolidinedione class of compounds, which are often associated with anti-inflammatory and uricosuric activities.
• Decomposition: Upon decomposition, specific toxic fumes may be released, including sulfur oxides and nitrogen oxides, requiring careful handling and disposal.
   

Sulfinpyrazone 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 Sulfinpyrazone manufacturing plant report also covers the leading technology providers that help you plan a robust plan of action related to Sulfinpyrazone 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 Sulfinpyrazone 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 Sulfinpyrazone 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 Sulfinpyrazone.
 

Key Insights and Report Highlights

Key Questions Covered in our Sulfinpyrazone Manufacturing Plant Report

• How can the cost of producing Sulfinpyrazone be minimized, cash costs reduced, and manufacturing expenses managed efficiently to maximize overall efficiency?
• What is the estimated Sulfinpyrazone manufacturing plant cost?
• What are the initial investment and capital expenditure requirements for setting up a Sulfinpyrazone 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 Sulfinpyrazone, 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 Sulfinpyrazone manufacturing?
• How do market price fluctuations impact the profitability and cost per metric ton (USD/MT) for Sulfinpyrazone, and what pricing strategy adjustments are necessary?
• What are the lifecycle costs and break-even points for Sulfinpyrazone 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 Sulfinpyrazone manufacturing?
• What types of insurance are required, and what are the comprehensive risk mitigation costs for Sulfinpyrazone manufacturing?