The report provides a detailed analysis essential for establishing an Oxaliplatin production plant. It encompasses all critical aspects necessary for Oxaliplatin production, including the cost of Oxaliplatin production, Oxaliplatin plant cost, Oxaliplatin production costs, and the overall Oxaliplatin production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Oxaliplatin 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.
Oxaliplatin is a platinum-based chemotherapeutic agent which is FDA-approved for treating advanced colorectal cancer. It is also used as adjuvant therapy in stage III colon cancer following primary tumour resection. Oxaliplatin combines with IV-infused 5-fluorouracil and leucovorin in the FOLFOX regimen, or with oral capecitabine in CAPOX and XELOX, to boost colorectal cancer treatment effectiveness. It shows efficacy in pancreatic, gastric, oesophageal, and biliary tract cancers, including cholangiocarcinoma and gallbladder cancer.
It is also utilised in refractory solid tumours in paediatrics, like neuroblastoma with doxorubicin, refractory lymphomas (e.g., non-Hodgkin, T-cell), and advanced ovarian, breast, and testicular cancers. Its common side effects include numbness and tingling in hands and feet (peripheral neuropathy), nausea, vomiting, diarrhoea, fatigue, low blood counts, etc.
The market for Oxaliplatin is influenced by growing cases of colorectal cancer around the globe. Its utilisation in managing stomach, ovarian, and other cancers contributes to its market growth. The industrial Oxaliplatin procurement is affected by the need for special cold storage during shipping to keep it safe, strict rules for making the raw ingredient (API), and problems like wars or shortages.
Other factors like complex supply chains involving cold chain logistics, regulatory hurdles for APIs, and disruptions from geopolitical events further impact its sourcing. Big companies like Sanofi, Dr Reddy's, and Yakult control most of the market, setting prices, and side effects like nerve pain also limit patients' utilisation, which affects market dynamics.
Raw Material for Oxaliplatin Production
According to the Oxaliplatin production plant project report, the key raw materials used in the production of Oxaliplatin include (1R,2R)-1,2-diaminocyclohexane dichloroplatinum(II) (DACHPtCl2) | Celite | Smopex-101.
Production Process of Oxaliplatin
The extensive Oxaliplatin production cost report consists of the following major industrial production process:
- From DACHPtCl2: The production process of Oxaliplatin starts by making a mixture of fine powdered DACHPtCl2, Celite, silver nitrate and water. This mixture is stirred at room temperature for 5 minutes and then at 45 degree Celsius for 2 hours. The suspension is cooled, filtered through active charcoal, and treated with Smopex-101. After that, oxalic acid dihydrate is added to the purified solution, pH adjusted to 2.9, stirred, and cooled. The resulting suspension is filtered, washed with ice water and ethanol, and dried under nitrogen flow to get pure Oxaliplatin as the final product.
Oxaliplatin appears as a white to off-white or pale yellow crystalline powder, with the molecular formula C8H14N2O4Pt (or anhydrous C8H12N2O4Pt) and a molecular weight of 397.29 g/mol. It shows slight solubility in water and DMSO. It is very slight solubility in methanol and is practically insoluble in ethanol or acetone. It shows a specific optical rotation of +74.5 to +78.0 degree (c=0.5 in water) and thermal decomposition around 200 degree Celsius. It has a square planar Pt(II) centre with a bidentate trans-1,2-diaminocyclohexane ligand and oxalate group, enabling DNA cross-linking. It has a monoisotopic mass of 397.060148 Da, two hydrogen bond donors, six acceptors, and a topological polar surface area of 82.3 Ų.