Atorvastatin Calcium Production Cost Reports

The report provides a detailed analysis essential for establishing an Atorvastatin Calcium manufacturing plant. It encompasses all critical aspects necessary for Atorvastatin Calcium production, including the cost of Atorvastatin Calcium production, Atorvastatin Calcium plant cost, Atorvastatin Calcium production costs, and the overall Atorvastatin Calcium manufacturing plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Atorvastatin Calcium production plant. These encompass manufacturing processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Atorvastatin Calcium is the calcium salt of Atorvastatin. It is a lipid-lowering medicine and a member of the statin class of drugs. It inhibits hydroxymethyl-glutaryl coenzyme A (HMG-CoA) reductase. It is used to lower the risk of cardiovascular disease and manage abnormal lipid levels by reducing the endogenous production of cholesterol in the liver.

The procurement of Atorvastatin Calcium is influenced by its application in the pharmaceutical and medical industries as an antihyperlipidemic drug used to lower the levels of LDL cholesterol. The need for Atorvastatin Calcium is increasing as cases of cardiovascular diseases are on the rise. The FDA has approved Atorvastatin Calcium to treat adults with primary hyperlipidemia and mixed dyslipidemia, homozygous familial hypercholesterolemia, pediatric patients with heterozygous familial hypercholesterolemia, hypertriglyceridemia, and primary dysbetalipoproteinemia, thus increasing its demand.

It witnesses a significant demand from the aging population as they are more likely to be affected by cardiovascular diseases. Various formulations are available for Atorvastatin Calcium, which increases its demand. It is also available in generic forms, which increases its affordability. Overall, the industrial Atorvastatin Calcium procurement is influenced by its application in the pharmaceutical and medical industries as an antihyperlipidemic agent, rising cases of cardiovascular disorders, the aging population, its wide range of applications, its availability in different dosage forms, along with cost-effectiveness, research and development, and regulatory approvals.

Raw Material for Atorvastatin Calcium Production

According to the Atorvastatin Calcium manufacturing plant project report, the key raw material used in the production of Atorvastatin Calcium includes 4-methyl-3-oxopentanoic acid methyl ester.

Manufacturing Process of Atorvastatin Calcium

The extensive Atorvastatin Calcium production cost report consists of the following major industrial manufacturing process:

• Production from 4-methyl-3-oxopentanoic acid methyl ester: The manufacturing process of Atorvastatin calcium starts with the reaction of 4-methyl-3-oxopentanoic acid methyl ester with aniline and ethylene diamine in toluene to form an intermediate. This intermediate undergoes a condensation reaction with benzaldehyde in hexane to form another intermediate. The intermediate is subjected to a stellar reaction with 4-fluorobenzaldehyde in an ethanol solution containing a catalytic amount of 3-ethyl-5-(2-hydroxyethyl)-4-methylthiazolium bromide and triethylamine to produce a diketone intermediate. The diketone is then subjected to Paal-Knorr pyrrole formation to form another intermediate. This intermediate is treated with dilute hydrochloric acid to produce a diol intermediate, which is treated with NaOH and followed by acidification with hydrochloric acid to form a lactone compound. The lactone compound is finally treated with NaOH and Ca(OAc)2 to produce Atorvastatin Calcium.

Atorvastatin Calcium is the calcium salt of Atorvastatin. It is commercially known as Lipitor. It is a white to off-white crystalline powder having the molecular formula C66H68CaF2N4O10 and a molecular weight of 1155.3 g/mol. It has a low water solubility of around 8.17e-05 mg/mL. It dissolves in methanol and acetonitrile. It dissolves to some extent in ethanol and is insoluble in aqueous solutions. The value of its log P is 6.98. The value of its dissociation constant, pKa, is 4.31. It is an HMG-co enzyme reductase inhibitor used to lower LDL levels and treat cardiovascular disorders.