Pipemidic Acid

Urinary tract infection is a clinically common infectious disease, and the rising drug resistance of its pathogenic bacteria has always been the focus of attention in clinical medication. Pipemidic acid is a second-generation quinolone antibacterial drug. It blocks bacterial DNA replication by inhibiting the activity of bacterial DNA gyrase, and has definite antibacterial activity against Gram-negative bacilli including Escherichia coli, Klebsiella pneumoniae, Proteus, etc. Clinically, it is mainly used for urinary tract infection and bacterial intestinal infection caused by sensitive bacteria, and can also be used for the treatment of superficial infections such as otitis media. It is a common treatment option for mild bacterial infections in primary medical institutions.

At present, the overall market size of quinolone antibacterial drugs in China is close to 15 billion yuan, among which oral quinolones account for more than 60% of the primary market. As a mature variety with a long launch time, pipemidic acid maintains stable demand in the medication for intestinal and urinary tract infections in community medical and county-level medical institutions by virtue of its cost-effectiveness advantage. Its annual market size is about 230 million yuan, and the annual growth rate is maintained at around 2%. There are more than 30 domestic preparation manufacturers, and the supply of API is dominated by local enterprises. The overall competition pattern is relatively scattered, and there is no oligopoly.

The original research enterprise of pipemidic acid is Japan's Dainippon Pharmaceutical Co., Ltd., and the original research brand name is PPA. Its core compound patent expired globally in 1999. The original research dosage forms are mainly tablets, with specifications including 0.25g and 0.5g, which are not included in the reference preparations in the Catalogue of Marketed Drugs in China at present. According to the domestic API registration platform, 6 enterprises have completed CDE registration of pipemidic acid API with the status of A, which can be legally supplied for preparation production. The domestically approved pipemidic acid preparations cover three categories: tablets, capsules and granules, with a total of more than 120 approval documents. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pipemidic acid, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable impurity reference standard support for API manufacturers, preparation R&D institutions and quality testing departments, effectively shortening the R&D cycle and reducing the cost of quality research.