Aztreonam

Gram-negative bacterial infection is a common challenge in clinical anti-infective therapy, and medication options have long been limited, especially for patients with β-lactam allergy. As a monobactam β-lactam antibiotic, aztreonam can selectively inhibit bacterial cell wall synthesis, has strong antibacterial activity against Gram-negative bacteria, and has an extremely low incidence of cross-allergic reactions with penicillins and cephalosporins. It is clinically used mainly to treat urinary tract infections, lower respiratory tract infections, sepsis, intra-abdominal infections, gynecological infections, and skin and soft tissue infections such as postoperative wounds, burns, and ulcers caused by susceptible bacteria. It is an important alternative medication for patients with β-lactam allergy suffering from Gram-negative bacterial infections, and can also be used for infection treatment in immunodeficient patients such as those with neutropenia.

At present, the global market size of aztreonam is stable at around USD 1.8 billion. Driven by factors such as the upgrading of drug-resistant bacteria prevention and control needs and the standardization of medication for perioperative infection prevention, the compound annual growth rate has maintained at 3.2% in recent years. The Chinese market is one of the fastest growing regions. In 2023, the sales volume at the public hospital terminal reached RMB 2.76 billion. In terms of the competitive landscape, the original research product still accounts for about 22% of the high-end hospital market, and domestic generic drugs have passed the consistency evaluation to achieve batch substitution. API enterprises in Zhejiang, Guangdong, Jiangsu and other regions are the core suppliers of global aztreonam API. After the implementation of domestic centralized procurement, the significant drop in preparation prices has greatly driven the increase in downstream clinical dosage, and the demand for API continues to be released.

The original research enterprise of aztreonam is Bristol-Myers Squibb, with the original trade name "Azactam", and its core compound patent expired globally in 2003. The original dosage form is aztreonam for injection, with conventional specifications including 0.5g, 1g and 2g, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for their aztreonam API, which can be officially supplied for preparation production. A total of 69 varieties of aztreonam for injection have been approved in China, among which 27 varieties have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of aztreonam quality research and production quality control, CATO provides a full set of impurity reference standards for this API. Most of the products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support enterprises in their impurity qualitative and quantitative research, stability investigation and registration declaration work.