Nalbuphine Production Cost Reports

The report provides a detailed analysis essential for establishing a Nalbuphine manufacturing plant. It encompasses all critical aspects necessary for Nalbuphine production, including the cost of Nalbuphine production, Nalbuphine plant cost, Nalbuphine production costs, and the overall Nalbuphine manufacturing plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Nalbuphine production plant. These encompass manufacturing processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Nalbuphine is a synthetic mixed opioid medication that is known for its strong analgesic properties. It is widely used as a drug for the treatment of moderate to severe pain associated with various causes, including surgery, trauma, cancer, biliary colic, or kidney pain. Moreover, it also finds its application as a supplementary drug for pre- and post-operational analgesia and as a pain killer in labor and delivery.

The market for Nalbuphine is primarily led by its role as an oral pain medication for relieving acute pain, which remarkably boosts its demand in the medical and pharmaceutical industries. Moreover, its utilization as an opioid agonist-antagonist to treat severe pain and as a supplementary drug for balanced anesthesia further enhances its demand in the medical and healthcare industries. Additionally, its usage in gynecological interventions significantly promotes its market expansion. Additionally, the availability of raw materials (Oxymorphone), cost and pricing, compliance with medical regulations, adherence to quality standards, supplier relationship, distribution (including trading and shipping), logistics, safety standards, etc., are some of the major factors that largely influence industrial Nalbuphine procurement.

Raw Material for Nalbuphine Production

According to the Nalbuphine manufacturing plant project report, the major raw material for Nalbuphine production includes Oxymorphone.

Manufacturing Process of Nalbuphine

The extensive Nalbuphine production cost report consists of the following industrial manufacturing process:

• Production from Oxymorphone: This method of production is initiated by the acetylation of oxymorphone, followed by its reaction with cyanogen bromide to form an N-cyano derivative compound and further hydrolyzing it by using hydrochloric acid to obtain 14-hydroxydihy-dronormorphone. Further, the obtained 14-hydroxydihydronormaphone undergoes reduction in the presence of sodium borohydride, followed by alkylation of the obtained product by using cyclobutylmethylbromide, which results in the formation of Nalbuphine as the final product.

Nalbuphine is an organic heterocyclic compound that is used as an analgesic. The molecular formula of the compound is C21H27NO4, and its molecular weight is 357.4 g/mol. Moreover, the compound serves as a drug that is primarily marketed under the trade names Nalbuphin and Nubain. The compound is administered orally and is also available in the injection. Its analgesic action is similar to that of morphine. Additionally, the compound exits in the form of a solid with melting point of 230°C as the hydrochloride salt. Its solubility in water is 35.5mg/mL at 25 °C as HCl salt. The dissociation constant value (pka) of Nalbuphine is 8.71, and Nalbuphine hydrochloride is 9.96 (HCl form). Additionally, the flash point of its HCl salt is 9°C and is generally stored at the temperature of -20°C. The compound is also observed to have adverse side effects, such as sedation and Dysphoria.