Amikacin

In response to the long-standing clinical challenge of drug-resistant bacteria posed by severe infections caused by Gram-negative bacteria, the emergence of the semi-synthetic aminoglycoside antibiotic amikacin has provided a core solution. It acts on the 30S subunit of bacterial ribosomes to block protein synthesis, and maintains strong antibacterial activity against multi-drug resistant bacteria such as *Pseudomonas aeruginosa*, *Escherichia coli*, and *Klebsiella* spp. Clinically, it is mainly used for the treatment of diseases such as sepsis, lower respiratory tract infections, bacterial endocarditis, and complicated urinary tract infections caused by susceptible bacteria. It is also a second-line drug for *Mycobacterium tuberculosis* infection, and the applicable population covers adults, children and immunocompromised patients with severe infections.

At present, the global market size of amikacin is approximately USD 1.26 billion, with a compound annual growth rate of 4.2% in the past three years. The core growth drivers come from the continuous rise in the incidence of drug-resistant bacterial infections worldwide, as well as the improvement of accessibility for diagnosis and treatment of severe infections in low- and middle-income countries. The competitive landscape of the domestic market is dominated by generic drugs. Domestic enterprises occupy more than 90% of the global API production capacity by virtue of cost advantages. Domestic preparations have been included in multiple rounds of national centralized procurement, with an average price reduction of over 60% for winning bids, which has greatly improved the accessibility of drugs in primary medical institutions.

The original research enterprise of amikacin is Bristol-Myers Squibb from the United States, with the original brand name Amikin. The US compound patent expired globally in 1997. At present, the main dosage forms approved for the original drug include injections, with specifications of 100mg/2mL, 500mg/2mL and 1g/4mL, which have been included in the FDA Reference Listed Drug Catalog and the China *List of Chemical Drugs*. For the domestic market, there are currently 31 valid registration numbers on the CDE API registration platform, of which 17 have been activated (A status). Multiple domestic enterprises have obtained marketing approvals for preparations such as amikacin for injection and amikacin injection. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for amikacin API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the usage needs of pharmaceutical enterprises in the whole process scenarios such as API R&D, quality research, and registration declaration.