Terconazole Production Cost Reports

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

Terconazole is a triazole antifungal agent that targets yeast infections by stopping ergosterol synthesis in fungal cell membranes. It effectively kills Candida species responsible for common vaginal issues. It is prescribed as a vaginal cream (0.4% or 0.8%) or suppository (80 mg) to treat vulvovaginal candidiasis in non-pregnant adult women.

It is applied once daily at bedtime for 3-7 days to quickly relieve symptoms like itching, burning, white discharge, and soreness. It shows activity against various Candida strains, including non-albicans types, and may serve for recurrent infection prophylaxis or dermatomycoses.  Its common side effects include headache, vaginal burning or irritation, abdominal or stomach pain, painful menstrual periods, and body aches.

The market for Terconazole is driven by increasing global cases of fungal infections. Its utilisation in vulvovaginal candidiasis, athlete's foot, and skin mycoses contributes to its market. The growing awareness of topical antifungals, self-care trends, and emphasis on women's reproductive health products fuels its growth. The availability of generic versions, improved healthcare in developing regions, and advancements in user-friendly formulations make it a popular medication.

The industrial Terconazole procurement is influenced by GMP-compliant API sources from Indian firms, Spanish suppliers, etc. Also, DMF filings, purity levels exceeding 99%, supply reliability, and competitive pricing through negotiations shape hospital and pharmacy decisions that impact its sourcing strategies.

Raw Material for Terconazole Production

According to the Terconazole production plant project report, the key raw materials used in the production of Terconazole include 1H-1,2,4-triazole | cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-ylmethyl benzoate | methanesulfonyl chloride | 1-(4-hydroxyphenyl)-4-(1-methylethyl)piperazine.

Production Process of Terconazole

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

1. From 1H-1,2,4-triazole: The production of Terconazole involves several steps. First, 1H-1,2,4-triazole reacts with cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-ylmethyl benzoate using sodium hydride. The reaction takes place in DMF and benzene to get triazole benzoate. The benzoate is hydrolysed with NaOH in dioxane and water, purified by chromatography to give the dioxolane methanol. This alcohol is mesylated with methanesulfonyl chloride in pyridine, purified to the mesylate. Finally, the mesylate couples with 1-(4-hydroxyphenyl)-4-(1-methylethyl)piperazine and K2CO3 in DMF, followed by deprotection to get Terconazole as the final product.

Terconazole is a triazole antifungal that has a molecular formula of C26H31Cl2N5O3 and a molecular weight of 532.47 g/mol. It appears as a white to almost-white crystalline powder. It has a melting point at 125–129 degree Celsius and a boiling point at 682 degree Celsius. It has a density of 1.35 g/cm³  and a logP value of 3.51–5.37. It has a pKa value of 8.4 (weak base, strongest basic site) and is insoluble in water. It is sparingly soluble in ethanol and soluble in butanol and DMSO. It has 0 H-bond donors, 7 acceptors, 8 rotatable bonds, and 5 rings. It is highly protein-bound (94.9), extensively metabolised (>95%) via oxidative dealkylation and ring cleavage, and is excreted renally and fecally.