Dolutegravir Production Cost Reports

The report provides a detailed analysis essential for establishing a Dolutegravir manufacturing plant. It encompasses all critical aspects necessary for Dolutegravir production, including the cost of Dolutegravir production, Dolutegravir plant cost, Dolutegravir production costs, and the overall Dolutegravir manufacturing plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Dolutegravir 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.

Dolutegravir is an organic heterotricyclic compound that serves as a drug in the medical industry. It is widely used as an FDA-approved drug in the treatment of HIV-1 infections in combination with other HIV medicines. It is used in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents, and children of at least 6 years of age or older. It also finds its application as a major component in the production of various antiretroviral drug combinations. It is also utilized in various research and clinical trials to evaluate its efficacy in HIV treatment. It is often used as a reference drug, or a model compound used in the development of new antiretroviral medications or in improving existing HIV treatments.

The market for Dolutegravir is primarily driven by its demand as an anti-viral agent utilized for the treatment of infection caused by Human Immunodeficiency Virus (HIV). Its utilization as a drug, in combination with other medicines in the treatment of HIV-1 infections, significantly promotes its demand in the pharmaceutical and healthcare industries. Its usage for research studies and clinical trials for synthesizing other antiretroviral drugs further enhances its demand in the medical research and biotechnology industries.

The production of Dolutegravir significantly depends on the availability of specific chemical precursors and intermediates. Several factors that affect the stability of the supply of these raw materials, such as market demand or regulatory changes, directly impact industrial Dolutegravir procurement. Dolutegravir must meet strict quality and safety standards set by regulatory bodies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) due to its major applications in the pharmaceutical industry. Thus, compliance with these regulations also serves as a crucial factor that affects the industrial procurement of dolutegravir. Additionally, patent issues that control manufacturing and distribution can greatly affect the supply and pricing of dolutegravir, which further impacts its procurement strategies.

Raw Material for Dolutegravir Production

According to the Dolutegravir manufacturing plant project report, the major raw materials for Dolutegravir production includes 4- Methoxyacetoacetic Acid Methyl Ester.

Manufacturing Process of Dolutegravir

The extensive Dolutegravir production cost report consists of the following industrial manufacturing process:

• Production from 4- Methoxyacetoacetic Acid Methyl Ester: In this method, 4- methoxyacetoacetic acid methyl ester is used as the starting material for the synthesis of Dolutegravir as the desired product. The process begins with the conversion of 4- methoxyacetoacetic acid methyl ester into its derivative, which is treated with CH3SO3H in acetonitrile to give an aldehyde. Further, the obtained aldehyde compound is cyclized with (R)-2-aminobutanol to form (4S,12aR)-4-Methyl-7-(methyloxy)-6,8- dioxo-3,4,6,8,12,12a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-9-carboxylic acid as an intermediate compound. Then, the obtained intermediate compound undergoes a coupling reaction with 2, 4-difluorobenzylamine, followed by de-methylation to obtain dolutegravir as the final product.

Dolutegravir is a monocarboxylic acid amide that is also commonly known by the brand names Tivicay and Tivicay PD. It is used as a medicine for the treatment of HIV infection. The molecular formula of the compound is C20H19F2N3O5. The molecular formula of Dolutegravir is 419.4 g/mol. The melting point of the compound is 190-193ºC. It is slightly soluble in water, and its pKa value is around 8.2. The compound appears as white to light yellow powder, and its LogP value is 2.2. It mainly serves as an antiviral agent in the medical industry.