Amikacin Production Cost Reports

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

Amikacin is a strong aminoglycoside antibiotic that is administered via injection for short-term treatment (7-10 days) of serious bacterial infections. It is effective against aerobic Gram-negative bacteria including Pseudomonas aeruginosa, Acinetobacter baumannii, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, and Serratia marcescens.

It is also utilised in Gram-positive organisms like Staphylococcus and Nocardia, along with mycobacterial strains. It is utilised in hospital-acquired and ventilator-associated pneumonia, sepsis and bacteremia, intra-abdominal infections, urinary tract infections, bone and joint infections, etc. It also finds its applications in managing central nervous system infections like neonatal meningitis and multidrug-resistant tuberculosis or non-tubercular mycobacteria as second-line therapy.

The market for amikacin is driven by the global rise in multidrug-resistant (MDR) bacterial infections. Its utilisation in hospital-acquired pneumonia, sepsis, and tuberculosis contributes to its market demand. The government antimicrobial stewardship programs, hospital infrastructure growth, and regulatory support for generics boost its adoption in hospitals. Its utilisation in cystic fibrosis and neonatal infections fuels its market. The frequent shortages from fragile supply chains, single-vendor dependencies, China-sourced API volatility, and GMP compliance costs influence industrial amikacin procurement.  Other factors like pricing stability, regulatory hurdles (FDA and EMA approvals), and disruptions from geopolitical issues affect its market dynamics.

Raw Material for Amikacin Production

According to the amikacin production plant project report, the key raw materials used in the production of amikacin include kanamycin A | N-(benzoyloxycarbonyloxy)succinimide | N-hydroxysuccinimide | (benzyloxycarbonyl)amino-α-L-2-hydroxybutyric acid.

Production Process of Amikacin

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

1. By Acylation: The production process of Amikacin involves a selective three-step process. First, the primary amino groups of kanamycin A are protected by acylation with N-(benzoyloxycarbonyloxy)succinimide in dimethylformamide, which forms a protected intermediate. After that, the 4-amino group of the intermediate in the deoxystreptamine region is selectively acylated using an activated ester derived from N-hydroxysuccinimide and (benzyloxycarbonyl)amino-α-L-2-hydroxybutyric acid. Finally, the two benzyloxycarbonyloxy protecting groups are removed via catalytic hydrogenolysis using hydrogen gas and palladium on carbon (Pd/C) catalyst to get pure amikacin.

Amikacin has the molecular formula of C22H43N5O13 with a molecular weight of 585.60 g/mol. It appears as a white to off-white hygroscopic crystalline powder or solid. It is freely soluble in water with a boiling point of around 642 degree Celsius. It has a density of 1.38 g/cm³ with a refractive index of 1.75. Its LogP value is in the range -5.8 to -3.8, making it highly hydrophilic. It has optical rotation of +99 degree (c=1.0) with a polar surface area of 331.94 Ų. It has 17 H-bond acceptors, 13 donors, and 10 rotatable bonds supporting its aminoglycoside structure. It decomposes before melting and is stored at 2-8 degree Celsius.