Tenapanor Production Cost Reports

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

Tenapanor is a gut-specific medicine that blocks a protein called NHE3, which normally absorbs sodium and water from the intestines into the body.  This helps to keep more water in the gut to soften stools and ease bowel movements. It treats irritable bowel syndrome with constipation (IBS-C) in adults, helping reduce hard stools, belly pain, bloating, and straining.

It is taken in a dose of 50 mg twice daily and shows results in weeks. It also lowers high phosphate levels in the blood for kidney disease patients on dialysis when standard binders fail, by trapping phosphate in the gut instead of letting it enter the bloodstream. Its common side effects include diarrhoea, abdominal bloating and distension, flatulence, dizziness, nausea, and increased abdominal sounds.

The market for Tenapanor is driven by the expanding chronic kidney disease (CKD). The rise in dialysis patients who require better hyperphosphatemia management contributes to its market growth. The rise in IBS-C cases and its strong performance fuel its market. The increasing ageing population leads to diabetes and hypertension cases, and processed diets worsen CKD and hyperphosphatemia, which supports the market further.

The industrial Tenapanor procurement is affected by pricing and payer hurdles despite superior efficacy and fewer pills versus binders. Other factors, like API supply from GMP suppliers in India and China, impact costs and generic timelines post-patent. Also, established binder competition and dialysis polypharmacy further shape its procurement strategies.

Raw Material for Tenapanor Production

According to the Tenapanor production plant project report, the key raw materials used in the production of Tenapanor include Bromoacetophenone, Amine, Sodium Borohydride, D-(+)-DBTA, and Benzenethiol.

Production Process of Tenapanor

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

1. From Bromoacetophenone: The Tenapanor synthesis starts with the reaction of bromoacetophenone and amine. This forms a ketone that is reduced via sodium borohydride to racemic alcohol. This alcohol goes through acidic intramolecular cyclisation, followed by resolution using D-(+)-DBTA to yield enantiomerically pure azacycle. After that, Buchwald-Hartwig coupling introduces benzenethiol to produce mercaptan, which converts to sulfonyl chloride through gaseous chlorination in acetic acid. The sulfonyl chloride reacts with diamine under mild basic conditions, and Boc deprotection affords the amine. This reacts with bis(isocyanate) and base, followed by methanolic HCl treatment to give Tenapanor hydrochloride salt as the final product.

Tenapanor has the molecular formula C50H66Cl4N8O10S2 (free base) or C50H68Cl6N8O10S2 (hydrochloride salt) with a molecular weight of 1145.04 g/mol (free base) or 1217.96 g/mol (HCl salt). It appears as a white to off-white or light brown hygroscopic amorphous solid. It is almost insoluble in water and shows moderate lipophilicity with a logP value between 4.55 and 5.02. It has an acidic pKa value of 9.86 and a basic pKa value of 6.84. It has a physiological charge of +1 with a high polar surface area between 218–235 Ų. Its hydrochloride form supports tablet formulation with excipients like hypromellose, requiring controlled humidity storage due to hygroscopicity.