Nafcillin

In response to the clinical treatment needs for infections caused by penicillin-resistant Staphylococcus aureus, nafcillin, as a representative variety of isoxazole class semi-synthetic penicillins, exerts a bactericidal effect by specifically binding to bacterial penicillin-binding proteins and inhibiting the synthesis of cell wall mucopeptides. Its unique molecular structure can resist hydrolysis by β-lactamase and has significant activity against enzyme-producing drug-resistant staphylococci. Clinically, it is mainly used to treat enzyme-producing staphylococcal infections such as sepsis, endocarditis, pneumonia, skin and soft tissue infections, etc. It is also applicable to patients with penicillin-resistant staphylococcal infections, and is an important drug option in the treatment system for drug-resistant Gram-positive bacterial infections.

At present, the global nafcillin market size is stable at around USD 420 million, with an annual compound growth rate of approximately 3.8%. The growth momentum mainly comes from the increase in the diagnosis and treatment rate of drug-resistant bacterial infections in primary medical institutions and the release of demand for perioperative infection prevention. The Chinese market accounts for about 12%, and the current competitive landscape is dominated by generic drugs, with the market share of the original research product being less than 20%. Domestic API manufacturers are concentrated in North China and East China. The APIs of 3 enterprises have been approved by the CDE, and the preparation products have been included in the centralized procurement catalogs of multiple provinces. The average drop in the winning bid price compared with the listing price has reached 47%, further improving clinical accessibility.

The original research enterprise of nafcillin is Bristol-Myers Squibb, with the original brand name Nafcil. The core compound patent expired globally in 1990. The main dosage form of the original research product is injection, with conventional specifications of 0.5g and 1g. It has been included in the FDA Orange Book Reference Listed Drug Catalog, and is also included in the China Listed Drug Catalog. At present, there are 5 domestic nafcillin API registration numbers, 3 of which are in A status and can be used in association with preparation declaration. For nafcillin sodium for injection, 11 domestic approval documents have been granted for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of nafcillin impurity reference standards, covering the full-path research requirements such as synthetic starting materials, intermediates, and degradation impurities. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference substance support for API R&D, quality research, and declaration and registration links.