Faropenem

In response to the clinical treatment needs of multi-drug resistant bacterial infections, faropenem sodium, as a representative variety of oral carbapenem antibiotics, exerts bactericidal activity by inhibiting the synthesis of bacterial cell walls. It shows broad-spectrum antibacterial effects against Gram-positive bacteria, Gram-negative bacteria and anaerobes, and is highly stable to β-lactamases. Its clinical indications cover respiratory system infections, urinary system infections, reproductive system infections, skin and soft tissue infections, and otorhinolaryngological infections caused by sensitive bacteria, etc. It is especially suitable for the sequential treatment of mild to moderate infections, which can effectively reduce the risk of adverse reactions of intravenous medication, and provides a convenient oral treatment option for patients with community-acquired infections and those receiving sequential treatment after discharge.

Driven by both the rising bacterial resistance rate and the expansion of the oral anti-infective drug market, the market of faropenem sodium has maintained a steady growth trend in recent years. In 2023, the sales volume in domestic sample hospitals exceeded 900 million yuan, with a compound growth rate of 12.7% in the past three years. In terms of the competitive landscape, the current domestic preparation market is dominated by domestic generic drugs, with the market share of original research products being less than 10%. On the API side, the number of domestic manufacturers is small, with fewer than 5 manufacturers having large-scale supply capacity. With the advancement of the consistency evaluation of generic drugs and the penetration of the primary medical market, there is still considerable room for the release of downstream demand.

The original research enterprise of faropenem sodium is Yamanouchi Pharmaceutical Co., Ltd. of Japan (now Astellas Pharma), with the original research trade name "Farom". Its core compound patent in Japan expired in 2009, and the compound patent in China expired in 2010. The main dosage forms of the original research product are tablets, with specifications including 100mg/tablet and 200mg/tablet, which have been included in the Pharmaceutical Standards of the Ministry of Health, Labour and Welfare of Japan and the Catalogue of Reference Preparations for Chemical Drugs of China. Up to now, 12 domestic enterprises have obtained Class A status for their faropenem sodium APIs through CDE registration, and another 23 domestic preparation products have been approved for marketing, covering three dosage forms: tablets, granules and capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for faropenem sodium API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of drug R&D, quality research and production.