Tacrolimus Production Cost Reports

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

Tacrolimus is a medication that helps prevent organ rejection after transplants and treats severe skin conditions like eczema. It works by calming down the immune system, specifically by stopping certain immune cells from becoming overly active, which reduces inflammation and helps the body accept the new organ or heal the skin. It is used in combination with other medications to prevent organ rejection during transplant in adults as well as children. Tacrolimus is utilized as a short-term treatment for moderate to chronic atopic dermatitis. It is also used for the treatment of other skin disorders like psoriasis, vitiligo, pyoderma, etc.

The industrial Tacrolimus procurement is driven by several factors, including its growing use in treating various skin conditions. It has grown in the medical field because of its use in organ transplantation to reduce the risk of organ rejection. Its usage in the treatment of atopic dermatitis when they are moderate to severe establishes it as a well-known product in the treatment of skin disorders. Its application in several other dermatoses further establishes it as a popular medication. Thus, its market is driven by approvals from regulators and new formulations, along with its usage in treating skin disorders and reducing organ rejections in transplantations.

Raw Material for Tacrolimus Production

According to the Tacrolimus manufacturing plant project report, the key raw materials used in the production of Tacrolimus include Streptomyces Tsukubaensis-Dextrose-Yeast Extract-Methanol.

Manufacturing Process of Tacrolimus

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

1. From Streptomyces Tsukubaensis, Dextrose, Yeast Extract, and Methanol: The manufacturing of Tacrolimus consists of several steps. First, the Streptomyces tsukubaensis bacterium is fermented in a nutrient-rich medium containing dextrose, yeast extract, etc. The fermentation takes place at a controlled temperature and pH to get maximum yield. After getting the maximum concentration of Tacrolimus, the fermentation broth is harvested, and Tacrolimus is extracted using methanol. Finally, the product is purified using chromatography to obtain pure Tacrolimus.

Tacrolimus appears as a white to off-white solid having a molecular formula of C44H69NO12. Its molecular weight is about 804.02 g/mol, and it has a density of about 1.19 g/cm³. Its melting point is in range from 113°C to 115°C and it has a boiling point of around 871.7°C. It is poorly soluble in water but freely soluble in ethanol, acetone, and DMSO. It has a pKa of about 9.97 making it weakly basic in nature. Its elimination half-life varies from 3.5 to 40.6 hours, and its oral bioavailability ranges from 5% to 67%.  All these physical and chemical properties contribute to its application as an immunosuppressive agent.