Tobramycin

Bacterial infection is a common clinical disease type, especially sepsis, central nervous system infections, respiratory and genitourinary tract infections caused by Gram-negative bacteria, which have always been the key areas of anti-infective treatment. Tobramycin is an aminoglycoside antibiotic. It exerts a bactericidal effect by binding to the 30S subunit of bacterial ribosomes and inhibiting the protein synthesis of pathogenic bacteria. It has outstanding antibacterial activity against multi-drug resistant Gram-negative bacteria such as *Pseudomonas aeruginosa*, *Escherichia coli* and *Klebsiella pneumoniae*. It is clinically used for neonatal sepsis, complicated urinary tract infection, superficial ocular infection and other diseases caused by sensitive bacteria, covering multiple applicable groups of adults, children and newborns, and is an important variety in the stepwise anti-infective treatment.

At present, the global market size of tobramycin is approximately USD 680 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the expansion of primary-level anti-infective demand and the expansion of drug use scenarios for cystic fibrosis-related pulmonary infections. The domestic market size is close to RMB 800 million, of which hospital drug use accounts for more than 65%. After the implementation of centralized procurement, the generic drug substitution rate has reached 82%. Domestic API supply dominates the market, with North China and East China as the core production clusters, and the overall supply stability is relatively high.

The original research enterprise of tobramycin is Novartis, and the original research brand name is "Tobrex". Its core compound patent expired globally in 1990. At present, the main dosage forms of the original research drug launched worldwide include injection (80mg/2ml), eye drop (0.3%, 5ml) and nebulized inhalation solution (300mg/5ml). Among them, eye drops and injection have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the FDA Reference Preparations Catalogue. Currently, there are 42 tobramycin API registration numbers in China, of which 36 are in A status, which can be legally supplied for associated preparation review. In addition, 19 domestic preparation products and 2 original research preparations have been approved for marketing in China. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the industry's R&D and quality control needs, CATO provides a full set of tobramycin impurity reference standards. Most products are available in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of the whole process of API R&D, quality research and declaration.