Gentamicin

Gram-negative bacterial infection is a common type of infection in clinical practice. Aminoglycoside antibiotics have always been an important medication option, especially in the treatment of acute and severe diseases such as abdominal infection, urinary tract infection and sepsis. As a classic variety of aminoglycosides, gentamicin blocks protein synthesis by binding to the 30S subunit of bacterial ribosomes, and has strong bactericidal activity against a variety of Gram-negative bacteria such as Pseudomonas aeruginosa, Escherichia coli and Klebsiella pneumoniae. Meanwhile, it also has a good effect on some methicillin-sensitive Staphylococci. Clinically, it can be used for neonatal sepsis, respiratory tract infection, biliary tract infection, skin and soft tissue infection and other types of diseases caused by sensitive bacteria, and can also be used as a perioperative prophylactic medication in related surgical procedures.

The global gentamicin market size has maintained steady growth for a long time. The market size in 2023 was approximately USD 680 million, and the compound annual growth rate from 2024 to 2030 is expected to be approximately 3.2%. The current market is dominated by generic drugs. India and China are the world's most important API suppliers, with their combined production capacity accounting for more than 85% of the global total. In the domestic market, gentamicin is a variety included in the National Essential Medicines List, and has been included in multiple rounds of provincial centralized procurement. The winning bid price tends to be stable, the clinical demand has obvious rigid characteristics, and the overall market supply and demand relationship has been in a balanced state for a long time.

The original developer of gentamicin is Merck & Co., Inc., with the original brand name Garamycin. The core compound patent of gentamicin expired worldwide in the 1970s. At present, the commonly used clinical dosage forms include injection (20mg/1ml, 40mg/1ml, 80mg/2ml), tablet (40mg), eye drop (0.3%) and other specifications. The original product has been included in the FDA Reference Listed Drug Catalog. As of now, there are 22 valid registration numbers of gentamicin APIs on the China CDE API Registration Platform, 16 of which are in status A and can be supplied for domestic preparation production. More than 200 domestic enterprises have obtained marketing approval for gentamicin-related preparations, covering all dosage forms such as injection, tablet, granule and eye drop. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the needs of gentamicin quality research and production quality control, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide reliable material basis support for pharmaceutical enterprises in work such as impurity qualitative and quantitative research, stability investigation and quality standard establishment.