Cefprozil

For common diseases such as upper and lower respiratory tract infections, skin and soft tissue infections caused by sensitive bacteria, cefprozil has become a commonly used oral anti-infective drug in clinical practice due to its precise action and high safety. As a second-generation cephalosporin, it exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, with outstanding antibacterial activity against Gram-positive bacteria and good inhibitory effect on some Gram-negative bacteria. It is applicable to adults and children over 6 months old, and is one of the mainstream options for empirical treatment of community-acquired infections.

The domestic market size of cefprozil has been stable at around RMB 1.5 billion for years. With the increasing demand for oral antibacterial drugs in the primary diagnosis and treatment market, the compound annual growth rate in the past three years has maintained at 4.2%. At present, the domestic preparation market is dominated by generic drugs, and oral dosage forms of more than 20 enterprises have been approved for marketing. After the implementation of centralized procurement, the average price reduction of winning bids reached 68%, which further promoted the improvement of clinical accessibility, and the market demand for upstream API also shows a trend of steady expansion.

The original developer of cefprozil is Bristol-Myers Squibb, and the original brand name is "Cefzil". The expiration date of its core compound patent in the United States is 2003, and the core patent in China expired in 2002. The main dosage forms approved for the original product are tablets and dry suspensions. The specifications of tablets include 0.25g and 0.5g, and the specifications of dry suspensions are 0.125g and 0.25g. Relevant dosage forms have been included in the Reference Listed Drug Catalogue published by NMPA, and are also included in the FDA Reference Listed Drug Catalogue. Up to now, nearly 30 domestic enterprises have obtained A status for their cefprozil API through CDE registration, which can be associated with preparation declaration or marketed for sale. The approved preparation varieties cover multiple dosage forms such as tablets, capsules and dry suspensions. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefprozil impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of impurity reference in API R&D, quality research and production processes.