Flucloxacillin

In response to the treatment needs of infectious diseases caused by drug-resistant Staphylococcus aureus, flucloxacillin, as an isoxazole class penicillin antibiotic, can resist the hydrolysis of bacterial β-lactamase by virtue of the steric hindrance effect of its side chain, solving the clinical pain point that ordinary penicillin drugs are ineffective against enzyme-producing drug-resistant bacteria. This drug has significant antibacterial activity against Gram-positive bacteria including penicillinase-producing staphylococci. It is clinically mainly used for the treatment of respiratory tract infections, skin and soft tissue infections, bone and joint infections, endocarditis and sepsis caused by sensitive bacteria, and is applicable to adult and pediatric patients with drug-resistant bacterial infections. It is one of the commonly used options for perioperative infection prevention and community-acquired infection treatment.

The global market size of flucloxacillin preparations is stable at around US$ 1.8 billion, with a compound annual growth rate maintained at 3.2%. The growth momentum mainly comes from the increase in demand for anti-infective drugs in primary medical institutions and the standardized application of prophylactic drugs in surgical operations. In the domestic market, this drug has been included in the centralized procurement catalogs of multiple provinces, and the price of the winning preparations has dropped by more than 70%, directly driving the continuous expansion of the demand for upstream API. At present, the domestic supply of compliant APIs is still dominated by local pharmaceutical companies, with sufficient import substitution space. The overall market competition pattern is characterized by the concentration of leading enterprises and the scarcity of compliant production capacity.

The original research enterprise of flucloxacillin is AstraZeneca, with the original research trade name Floxapen, and its core compound patent expired globally in the 1990s. The main dosage forms of the original research include capsules (250mg, 500mg), injections (250mg, 500mg, 1g) and oral suspensions. Among them, capsules and injections have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, 6 domestic enterprises have obtained the A status for their flucloxacillin APIs through CDE registration, and another 12 related preparations have been approved for marketing, covering mainstream dosage forms such as flucloxacillin sodium for injection and flucloxacillin sodium capsules. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for flucloxacillin API, covering the full-path research needs including synthetic starting materials, intermediates and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. Meanwhile, they meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process technical needs of pharmaceutical enterprises in process development, quality research and registration declaration.