Ulipristal Production Cost Reports

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

Ulipristal is a selective progesterone receptor modulator (SPRM) that works as an antiprogestin for emergency contraception and uterine fibroid management. It is used as emergency contraception as a single 30 mg oral dose effectively delays ovulation. It stops the luteinising hormone surge up to 120 hours post-unprotected intercourse, mainly in the 72–120-hour window without impacting implantation. It is utilised in uterine fibroids in premenopausal women with intermittent 3-month courses of 5 mg daily. It reduces heavy menstrual bleeding, induces amenorrhea, and shrinks fibroid volume by 30-60% via apoptosis and anti-angiogenic effects. Its common side effects include headache, nausea, abdominal or stomach pain, fatigue or tiredness, dizziness, and painful menstrual periods or dysmenorrhea.

The market for Ulipristal is driven by growing unintended pregnancies and the growing cases of uterine fibroids in women over 35. The demand for better emergency contraception effective up to 120 hours post-intercourse, plus non-surgical fibroid options, contributes to its market growth. The rise in awareness of women's health, reproductive advocacy, family planning access, and emergency contraception contributes to its market in hospitals, retail, and online.

Also, reproductive health focus, government programs, along with non-invasive therapy preferences fuels its demand. Also, strict regulations, R&D for endometriosis, and insurance coverage affect its market dynamics. The industrial Ulipristal procurement is influenced by cGMP and GMP suppliers offering DMFs, COAs, USP and EP purity. Other factors like availability of generics, disruptions in supply and price impacts its sourcing strategies.

Raw Material for Ulipristal Production

According to the Ulipristal production plant project report, the key raw materials used in the production of Ulipristal include 3-(ethylenedioxy)-19-estra-5(10),9(11)-diene-17-one | phenylsulfenyl chloride | 4-(N, N-dimethylamino)phenylmagnesium bromide.

Production Process of Ulipristal

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

1. By Alkylation: The production of Ulipristal follows an industrial-scale route that uses  3-(ethylenedioxy)-19-estra-5(10),9(11)-diene-17-one. First, its alkylation with tBuOK and acetylene gives alcohol, which is treated with phenylsulfenyl chloride that forms thiolester and sulfinate-sulfoxide rearrangement to allene sulfoxide. The sulfoxide goes through NaOMe and MeOH treatment to get enol ether, then trimethyl phosphite for rearrangement to hydroxyl enol ether, followed by demethylation to ketone and protection with ethylene glycol. Epoxidation with hexachloroacetone and H2O2 gives an epoxide mixture, which is reacted with 4-(N, N-dimethylamino)phenylmagnesium bromide. Finally, it is dehydrated followed by acetylation to give ulipristal acetate.

Ulipristal appears as a white to yellow-green crystalline powder form with a molecular weight of 475.62 g/mol. It has a melting point of 184-188 degree Celsius with specific rotation of +173 to +183 degree (c=1, CHCl3). It has low water solubility, typical of steroidal compounds, with a logP of around 5-6 for lipophilicity. It has five rings, four hydrogen bond acceptors, no donors and a polar surface area of 63.68 Ų. It is basic with a pKa value of around 4.89 and is stable under heat-sensitive storage at -20 degree Celsius. All these physical and chemical properties make it useful as an antiprogestin.