Mezlocillin

Gram-negative bacterial infection is a key area of clinical anti-infective treatment, especially for respiratory and urinary tract infections caused by drug-resistant bacteria such as *Pseudomonas aeruginosa*, and the clinical demand for drugs that combine safety and antibacterial activity continues to rise. Mezlocillin is a broad-spectrum semi-synthetic penicillin antibiotic, which exerts a bactericidal effect by inhibiting the activity of bacterial cell wall mucopeptide synthetase and blocking cell wall synthesis. Its antibacterial activity against Gram-negative bacteria is significantly better than that of ampicillin. Clinically, it is mainly used for infections of the respiratory system, urinary system, digestive system, gynecology and reproductive organs caused by sensitive bacteria, and can also be used for the treatment of moderate to severe infections such as sepsis, purulent meningitis, peritonitis and osteomyelitis. The applicable population covers adult and pediatric patients with no history of penicillin allergy.

The anti-infective drug market has long occupied an important share of the global pharmaceutical market, among which semi-synthetic penicillin drugs have always maintained stable demand due to their clear clinical positioning and outstanding cost-effectiveness. Data show that in recent years, the domestic market size of mezlocillin-related preparations is about 1.2 to 1.5 billion yuan, with an annual compound growth rate of around 4%. The market is dominated by generic drugs, and the proportion of original research products is less than 10%. At present, more than ten domestic enterprises have obtained the production qualification of mezlocillin preparations. The price of preparations in the areas covered by centralized procurement has dropped by more than 60%, and the supply stability of upstream API has become a core influencing factor for the cost control of downstream preparation enterprises.

The original research enterprise of mezlocillin is Bayer AG, and the original brand name is "Baypen". Its core compound patents in major global markets expired before 2002. The main dosage forms approved for the original product are injections, with specifications including 0.5g, 1.0g and 2.0g. The original mezlocillin for injection has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. According to the domestic API registration platform, at present, 6 enterprises' mezlocillin APIs have obtained A status through CDE registration and can be legally supplied for domestic preparation production. The domestic approved preparation products are mainly mezlocillin for injection and mezlocillin sodium and sulbactam sodium for injection. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the demand for quality research and compliance of mezlocillin, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of different scenarios such as API production, preparation research and development, and quality testing.