Valsartan Manufacturing Plant Project Report: Key Insights and Outline

Valsartan 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.

Valsartan is a medication used primarily to treat high blood pressure (hypertension) and heart failure. It is primarily used as a drug for the treatment of hypertension (high blood pressure). It is also utilized as a medicine to manage heart failure and in therapies post-myocardial infarction (heart attack). It is also used to treat kidney disease associated with type 2 diabetes and helps to slow disease progression. Valsartan is often combined with other antihypertensive agents (such as hydrochlorothiazide or sacubitril) to create combination drugs for chronic heart conditions. It also finds its application as a cardiovascular drug in the treatment of left ventricular dysfunction.
 

Top Manufacturers of Valsartan

• Hetero Labs
• Dr. Reddy's Laboratories
• Sun Pharma
• Lupin
• Mylan
• Teva Pharma
• Zhejiang Hisun Pharma
• Jubilant Pharmova
• Aurobindo Pharma
• Torrent Pharmaceuticals
   

Feedstock for Valsartan

The feedstock involved in the production of Valsartan is 4-Methyl-2-cyano-biphenyl. Variations in the availability and cost of raw materials involved in the production of 4-methyl-2-cyano-biphenyl directly impact its production, costs, and sourcing strategies. 4-Methyl-2-cyano-biphenyl is used primarily in the production of liquid crystal materials, which are crucial for the manufacturing of LCDs.

The growth and demand in the electronics sector, particularly for displays in smartphones, televisions, and other consumer electronics, have a direct impact on the sourcing of 4-methyl-2-cyano-biphenyl. Increased demand for LCDs and advancements in display technologies can increase the demand for 4-Methyl-2-cyano-biphenyl, which further affects its pricing and sourcing decisions.

The production of chemicals like 4-methyl-2-cyano-biphenyl involves the use of hazardous substances, such as cyanide or methylating agents. Therefore, adherence to regulations related to chemical safety, waste disposal, emissions, and the handling of toxic substances can further impact production costs and sourcing strategies for 4-methyl-2-cyano-biphenyl.
 

Market Drivers for Valsartan

The primary factor that drives the market for Valsartan is its demand as an antihypertensive drug used to treat hypertension and manage heart failure. Its utilization as a drug for the treatment and management of heart failure significantly promotes its demand in the pharmaceutical industry. Its application as a therapeutic agent in the treatment of high blood pressure or hypertension further enhances its demand in the pharmaceutical industry.

Its involvement as a combination drug used with other antihypertensive drugs to treat heart disorders also contributes to its demand in the pharmaceutical and healthcare industries. Its usage as a medication to slow down the progression of nephropathy in type 2 diabetes further fuels its demand in the medical, pharmaceutical, and healthcare industries.

The industrial Valsartan procurement is significantly affected by fluctuations in the availability and cost of these raw materials. Factors like supply chain disruptions, seasonal production changes, or market demand for other chemicals can directly affect the availability of raw materials, which in turn impact procurement strategies for Valsartan. The demand for Valsartan is influenced by its clinical applications, primarily in the treatment of hypertension and heart failure.

Variations in the demand based on the prevalence of these conditions, adoption of new treatments, or changes in global healthcare policies directly affect pricing and procurement decisions for Valsartan. The pharmaceutical industry is heavily regulated. Compliance with regulatory standards set by agencies like the FDA (Food and Drug Administration), EMA (European Medicines Agency), etc., also plays a crucial role in the procurement of Valsartan.

The capital expenditure (CAPEX) for manufacturing valsartan includes all the initial costs needed to set up and equip the production plant. It includes the cost of purchasing or leasing the land and building the facility. A significant part of CAPEX also goes toward buying and installing specialized machinery like reactors, agitators, condensers, liquid-liquid extractors, vacuum distillation units, crystallizers, vacuum filtration apparatuses, and drying ovens.

The construction costs of cleanrooms and laboratories for quality control, research, and development purposes, along with storage tanks for raw materials and finished products, further add to CAPEX. Investments in safety equipment like fire suppression systems and protective gear for workers also contribute to CAPEX. Environmental protection measures, such as wastewater treatment and air filtration systems, depending on local regulations, also fall under CAPEX.

Operating expenditure (OPEX) covers the ongoing costs to run the valsartan manufacturing plant on a daily basis. Major OPEX expenses include purchasing raw materials, labor costs for employees involved in production, quality control, plant maintenance, and energy consumption. Maintenance of equipment and expenses related to safety procedures, waste management, and compliance with regulatory standards all contribute to OPEX. Packaging and distribution costs for shipping the final product to market also form a part of OPEX.
 

Manufacturing Process

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

• Production from 4-Methyl-2-cyano-biphenyl: The feedstock required for this process includes 4-methyl-2-cyano-biphenyl.

The production of Valsartan from 4'-methyl-2-cyano-biphenyl involves several key steps. Initially, 4'-methyl-2-cyano-biphenyl is converted into a tetrazole ring using sodium azide and Et3N·HCl as a catalyst, followed by neutralization, extraction, and reacidification to yield pure biphenyltetrazole.  Then, the tetrazole ring is protected with trityl chloride in dichloromethane and triethylamine.

The protected intermediate undergoes selective bromination using N-bromosuccinimide in tetrachloromethane with AIBN, forming 4’-bromo-methyl-2-(N-trityl-1H-tetrazol-5-yl)-biphenyl. Further, the compound is subjected to benzolation with L-valine methyl ester hydrochloride in acetonitrile and potassium carbonate, followed by acylation with valeroyl chloride. The trityl protecting group is then removed using hydrochloric acid in methanol to form the free tetrazole derivative. Finally, the obtained compound undergoes hydrolysis with sodium hydroxide, which produces Valsartan as the final product.
 

Properties of Valsartan

Valsartan appears as a white to off-white crystalline powder with the molecular formula C24H29N5O3 and a molecular weight of approximately 435.5 g/mol. It is freely soluble in ethanol and methanol, but only sparingly soluble in water (about 0.18 g/L at 25 degree Celsius), with its solubility increasing significantly at higher pH. The melting point of the compound is in the range of 105–110 degree Celsius, and its boiling point is around 684.9 degree Celsius.

The pKa value of the compound is 3.9, and it has a 1.212 ± 0.06 g/cm³. Valsartan contains both a carboxylic acid and a tetrazole ring, which contribute to its pH-dependent solubility and hydrophilic character. It is a derivative of valine with a biphenyl-tetrazole structure, which makes it stable under dry storage conditions and suitable for oral administration.

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

Key Insights and Report Highlights

Key Questions Covered in our Valsartan Manufacturing Plant Report

• How can the cost of producing Valsartan 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 a Valsartan 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 Valsartan, 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 Valsartan manufacturing?
• How do market price fluctuations impact the profitability and cost per metric ton (USD/MT) for Valsartan, and what pricing strategy adjustments are necessary?
• What are the lifecycle costs and break-even points for Valsartan 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 Valsartan manufacturing?
• What types of insurance are required, and what are the comprehensive risk mitigation costs for Valsartan manufacturing?