Sunitinib Production Cost Reports

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

Sunitinib is a multi-targeted receptor tyrosine kinase inhibitor, which treats gastrointestinal stromal tumours (GIST) in patients resistant or intolerant to imatinib. It works by blocking certain proteins cancer cells need to grow blood vessels and spread. It is utilised to treat advanced kidney cancer where tumours have spread or come back.

It is also used for stomach tumours that don't respond to other drugs like imatinib, stopping these hard-to-treat growths from getting bigger by targeting signals inside the cancer cells. It treats rare pancreas neuroendocrine tumours that can't be removed by surgery or have spread, giving patients more time by shrinking or stabilising them when other options fail. Its common side effects include fatigue, diarrhoea, mouth sores, nausea, hand-foot rash, high blood pressure, bleeding, taste changes, hair loss, headache, and dry mouth.

The market for Sunitinib is influenced by growing cancer cases, mainly renal cell carcinoma, gastrointestinal stromal tumors and neuroendocrine tumours. The ageing populations, along with improved diagnostics, healthcare infrastructure growth and rising oncology investments contributes to its market growth.

Also, generic biosimilar launches following patent expiry, R&D in personalised therapies and nanocarrier delivery systems expands its applications. The industrial Sunitinib procurement is affected by the need to secure GMP-certified API from suppliers offering USDMF CEP WC filings and polymorphic purity control. Other factors like competitive pricing and quality assurances amid challenges like cost fluctuations, supply disruptions, trade policies, patent litigations, and competition from alternative TKIs impact its sourcing strategies.

Raw Material for Sunitinib Production

According to the Sunitinib production plant project report, the key raw materials used in the production of Sunitinib include 5-((Z)-(5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid | N, N-diethylethylenediamine | EDCI hydrochloride | hydroxybenzotriazole.

Production Process of Sunitinib

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

1. By Amide Coupling: The production process of Sunitinib involves amide coupling of 5-((Z)-(5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid with N, N-diethylethylenediamine. This is done using EDCI hydrochloride, hydroxybenzotriazole, and triethylamine in tetrahydrofuran at room temperature. Followed by the addition of the amine and stirring. The reaction mass is diluted with saturated sodium bicarbonate, adjusted to alkaline pH using sodium hydroxide solution, extracted with ethyl acetate and dried to get pure Sunitinib as the final product.

Sunitinib appears as a yellow to orange-yellow non-hygroscopic powder. It has the molecular formula of C22H27FN4O2  with a molecular weight of 398.48 g/mol. It features a pyrrole carboxamide linked via exocyclic double bond (Z) to 5-fluoroindolin-2-one and N-(diethylaminoethyl) side chain. It displays pH-dependent solubility with a pKa value of 8.95. It has the logP value of 2.94 and topological polar surface area 77.23 Ų. It has three H-bond donors, eight rotatable bonds and collision cross sections of 207.0 Ų [M+H]⁺ / 214.3 Ų [M+Na]⁺ in ESI-MS. It exhibits polymorphism and stops RTKs via ATP-competitive binding, and requires enteric coatings for oral bioavailability.