Piperacillin

In response to the clinical dilemma of rising drug resistance in Gram-negative bacteria, piperacillin, a semi-synthetic ureido broad-spectrum penicillin, exerts bactericidal activity by inhibiting the synthesis of bacterial cell wall mucopeptides, and maintains high sensitivity to multi-drug resistant bacteria such as *Pseudomonas aeruginosa*, *Escherichia coli* and *Klebsiella pneumoniae*. It is often clinically formulated into a compound preparation with the β-lactamase inhibitor tazobactam, which is used for the treatment of moderate to severe hospital-acquired pneumonia, complicated urinary tract infection, abdominal infection, and bloodstream infection, covering high-risk groups such as ICU patients, post-surgical patients, and immunodeficient patients with concurrent infections, and is one of the core drugs for empirical treatment of severe infections.

Piperacillin compound preparations are the core varieties in the global anti-infective market. In 2023, the global market size reached USD 2.87 billion, with a compound annual growth rate of 4.2% in the past five years. In the domestic market, the sales volume in sample hospitals in the first half of 2024 reached RMB 1.23 billion, ranking fourth among systemic antibacterial drugs. The competitive landscape is dominated by generic drugs. At present, more than 30 enterprises have obtained approval for the production of piperacillin and tazobactam preparations. After the centralized procurement, the price has dropped by more than 80%, further promoting the increase of penetration rate in primary medical institutions, and the demand for upstream API maintains an annual growth rate of about 10%.

The original developer of piperacillin is Pfizer, and the original compound preparation is sold under the trade name Tazocin®. The core compound patent expired globally in 2003, and the preparation patent in China expired in 2007. The main dosage form approved in China is piperacillin sodium and tazobactam sodium for injection, with three common specifications: 1.125g (1g piperacillin/0.125g tazobactam), 2.25g and 4.5g. The original product has been included in the *Reference Preparation Catalogue of Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 26 piperacillin API registration entries on the API registration platform of China CDE, among which 19 are in status A (already used in marketed preparations), and the supply of domestic APIs has been fully independent and controllable. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full range of piperacillin impurity reference standards, which can perfectly match the full-process requirements such as quality research, stability study, and registration declaration of APIs and preparations. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can be directly used in various declaration scenarios.