Ansofaxine Production Cost Reports

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

Ansofaxine is an extended-release oral antidepressant utilised for major depressive disorder (MDD). It shows improvements in anhedonia, motivation, and functional outcomes like CGI-S and SDS. It is utilised as a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) and raises extracellular levels of these monoamines in key brain regions. It works as a next-generation option for patients with inadequate responses to SSRIs or SNRIs, mainly in those with prominent low energy or reward deficits. It is also utilised in oncology adjunct roles like stopping colon cancer growth via anti-TNFR2 immunotherapy synergy and hepatocellular carcinoma. Its common side effects include nausea, vomiting, diarrhoea, dizziness, headache, dry mouth, insomnia, sweating, etc.

The market for Ansofaxine is driven by growing major depressive disorder (MDD) because of urbanisation stress. The ageing populations, along with strong clinician and patient demand for its serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) profile contributes to its market growth. Also, approval from the NMPA as an innovative antidepressant, strategic inclusion in the  National Reimbursement Drug List (NRDL) fuels its market.

The industrial Ansofaxine procurement is influenced by its usage in hospitals, centralised purchasing agencies, and distributors revolve around competitive hospital tenders. Also, instability in the availability of its API raw material, regulatory advantages like 6-year market exclusivity under NMPA Class 1 status, along with favourable toxicology and pharmacovigilance profiles supports its market.

Raw Material for Ansofaxine Production

According to the Ansofaxine production plant project report, the key raw materials used in the production of Ansofaxine include p-Hydroxyphenylacetonitrile, benzyl bromide, potassium carbonate, cyclohexanone, sodium hydroxide, and tetrabutylammonium bromide.

Production Process of Ansofaxine

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

1. From p-Hydroxyphenylacetonitrile: The production process of  Ansofaxine hydrochloride involves multiple steps. It starts with the Benzyl protection of p-hydroxyphenylacetonitrile that leads to the formation of 4-benzyloxyphenylacetonitrile. This is followed by nucleophilic addition to cyclohexanone, giving 1-[cyano(4-benzyloxyphenyl)methyl]cyclohexanol. After that, catalytic hydrogenation (Pd/C) deprotects benzyl and reduces nitrile to 1-[2-amino-1-(4-hydroxyphenyl)ethyl]cyclohexanol hydrochloride. After that, Eschweiler-Clarke N, N-dimethylation with formaldehyde and formic acid leads to the formation of an O-desmethylvenlafaxine (ODV) free base. Final acylation of ODV with 4-methylbenzoyl chloride in dichloromethane and triethylamine takes place, followed by purification and HCl salt formation to give Ansofaxine hydrochloride as the final product.

Ansofaxine has the molecular formula of C24H31NO3 (free base) with a molecular weight of 381.52 g/mol. Its hydrochloride salt has the molecular formula of C24H32ClNO3 with a molar mass of 417.98 g/mol. It appears as a white crystalline powder with a melting point of 159–162 degree Celsius for the HCl salt. It has a topological polar surface area of 49.8 Ų and high lipophilicity (XLogP3-AA ~4.5), supporting oral bioavailability as an extended-release antidepressant. All these physical and chemical properties make it useful as a triple reuptake inhibitor targeting serotonin, dopamine, and norepinephrine transporters.