The report provides a detailed analysis essential for establishing a Dapagliflozin production plant. It encompasses all critical aspects necessary for Dapagliflozin production, including the cost of Dapagliflozin production, Dapagliflozin plant cost, Dapagliflozin production costs, and the overall Dapagliflozin production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Dapagliflozin production plant.
These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Dapagliflozin is a medication prescribed as a complementary oral antidiabetic drug on top of lifestyle modifications to treat patients with type-2 diabetes mellitus. It is a sodium-glucose cotransporter 2 inhibitor indicated for the reduction of end-stage renal disease, heart failure hospitalizations, cardiovascular death, and worsening of eGFR in patients with chronic kidney disease at high risk of progression.
The procurement of Dapagliflozin is influenced by its application in the pharmaceutical and medical industries as an antidiabetic medication used to treat type-2 diabetes mellitus. The widespread occurrence of type-2 diabetes is significantly increasing the demand for Dapagliflozin.
It witnesses a significant demand from the aging population as they are more likely to be affected by diabetes. Clinical research has demonstrated that the drops in HbA1c levels seen with Dapagliflozin are similar to those seen with other oral diabetic medicines and other SGLT2 inhibitors, such as Canagliflozin which puts Dapagliflozin in a competitive position within the diabetic therapy market, attracting the interest of medical professionals and patients alike.
Its safer profile and better tolerability when compared to other diabetic drugs makes it more appealing to patients and medical professionals, which fuels the expansion of the market. Overall, industrial Dapagliflozin procurement is influenced by its application in the pharmaceutical and medical industries, the rising cases of type-2 diabetes mellitus, the aging population, greater efficacy, fewer side effects, better tolerability, and regulatory approvals.
Raw Material for Dapagliflozin Production
According to the Dapagliflozin production plant project report, the key raw material used in the production of Dapagliflozin includes aryl bromide.
Production Process of Dapagliflozin
The extensive Dapagliflozin production cost report consists of the following major industrial production process:
- Production from aryl bromide: The production process of Dapagliflozin starts with the reaction of the trimethylsilyl (TMS)-protected gluconolactone with aryllithium formed by Br/Li exchange of aryl bromide with n-BuLi. The resulting mixture is reacted with methanesulfonic acid in the presence of methanol to form methyl C-aryl glycoside. The compound undergoes acetylation with Ac2O to give an intermediate, which is further reduced to another intermediate with triethylsilane (Et3SiH) and BF3·Et2O. Finally, the intermediate is subjected to hydrolysis with lithium hydroxide to produce Dapagliflozin.
Dapagliflozin, commercially known as Edistride, is a white to off-white crystalline powder having the molecular formula C21H25ClO6 and a molecular weight of 408.9 g/mol. Its melting point and boiling point are measured at 65 °C and 609 °C, respectively. It has a log P value of 2.7. It has an estimated water solubility of 0.173 mg/mL. The value of its dissociation constant, pKa, is 12.57. It is a member of the class of drugs called sodium-glucose cotransporter 2 inhibitors used to manage type 2 diabetes mellitus.